Na snazi

Objavljeno u NN 79/10 od 24.06.2010.:

MINISTARSTVO ZDRAVSTVA I SOCIJALNE SKRBI

Na temelju članka 8. stavka 2. Zakona o medicinskim proizvodima (»Narodne novine«, br. 67/08), te na temelju dostavljenog popisa hrvatskih norma na području medicinskih proizvoda od Hrvatskog zavoda za norme, ministar zdravstva i socijalne skrbi objavljuje

POPIS HRVATSKIH NORMA ZA MEDICINSKE PROIZVODE 2010-05-24

Aktivni medicinski proizvodi za ugradnju

Oznaka hrvatske norme	Naslov hrvatske norme	Oznaka europske norme	Naslov engleske norme
HRN EN 556-1:2008		EN 556-1:2001	Sterilization of medical devices – Requirements for medical devices to be designated »STERILE« – Part 1: Requirements for terminally sterilized medical devices (EN 556-1:2001+AC:2006)
HRN EN 556-2:2008		EN 556-2:2003	Sterilization of medical devices – Requirements for medical devices to be designated »STERILE« – Part 2: Requirements for aseptically processed medical devices (EN 556-2:2003)
HRN EN 980:2008		EN 980:2008	Symbols for use in the labelling of medical devices (EN 980:2008)
HRN EN 1041:2008		EN 1041:2008	Information supplied by the manufacturer of medical devices (EN 1041:2008)
HRN EN ISO 11135-1:2008		EN ISO 11135-1:2007	Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007; EN ISO 11135-1:2007)
HRN EN ISO 11137-1:2007	Sterilizacija proizvoda za zdravstvenu skrb – Zračenje – 1. dio: Zahtjevi za razvoj, vrednovanje i kontrolu provedbe sterilizacijskog postupka za medicinske proizvode (ISO 11137-1:2006; EN ISO 11137-1:2006)	EN ISO 11137-1:2006	Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006; EN ISO 11137-1:2006)
HRN EN ISO 11137-2:2008		EN ISO 11137-2:2007	Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01; EN ISO 11137-2:2007)
HRN EN ISO 11737-1:2006	Sterilizacija medicinskoga pribora – Mikrobiološke metode – 1. dio: Određivanje vrste i broja mikroorganizama na proizvodima (ISO 11737-1:2006; EN ISO 11737-1:2006)	EN ISO 11737-1:2006	Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006; EN ISO 11737-1:2006)
HRN EN ISO 13485:2003	Medicinski uređaji – Sustavi upravljanja kvalitetom – Zahtjevi za zakonsku namjenu (ISO 13485:2003; EN ISO 13485:2003)	EN ISO 13485:2003	Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2003; EN ISO 13485:2003)
HRN EN ISO 13485:2003/Ispr.1:2008	Medicinski uređaji – Sustavi upravljanja kvalitetom – Zahtjevi za zakonsku namjenu (EN ISO 13485:2003/AC:2007)	EN ISO 13485:2003/AC:2007	Medical devices – Quality management systems – Requirements for regulatory purposes (EN ISO 13485:2003/AC:2007)
HRN EN 13824:2007	Sterilizacija medicinskih proizvoda – Sterilna priprema tekućih medicinskih proizvoda – Zahtjevi (EN 13824:2004)	EN 13824:2004	Sterilization of medical devices – Aseptic processing of liquid medical devices – Requirements (EN 13824:2004)
HRN EN ISO 14155-1:2008		EN ISO 14155-1:2003	Clinical investigation of medical devices for human subjects – Part 1: General requirements (ISO 14155-1:2003; EN ISO 14155-1:2003)
HRN EN ISO 14155-2:2008		EN ISO 14155-2:2003	Clinical investigation of medical devices for human subjects – Part 2: Clinical investigation plans (ISO 14155-2:2003; EN ISO 14155-2:2003)
HRN EN ISO 14937:2005	Sterilizacija proizvoda za zdravstvenu skrb – Opći zahtjevi za značajke sredstva za sterilizaciju i za provedbu, ocjenjivanje i tijek ispitivanja provedbe sterilizacije medicinskih proizvoda (ISO 14937:2000+Cor 1:2003; EN ISO 14937:2000+AC:2003+AC:2005)	EN ISO 14937:2000	Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000+Cor 1:2003; EN ISO 14937:2000+AC:2003+AC:2005)
HRN EN ISO 14971:2009		EN ISO 14971:2007	Medical devices – Application of risk management to medical devices (ISO 14971:2007; EN ISO 14971:2007)
HRN EN ISO 17665-1:2008		EN ISO 17665-1:2006	Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006; EN ISO 17665-1:2006)
HRN EN 45502-1:2000	Aktivni implantabilni medicinski uređaji – 1. dio: Opći zahtjevi za sigurnost, označivanje i obavijesti koje mora dati proizvođač (EN 45502-1:1997)	EN 45502-1:1997	Active implantable medical devices – Part 1: General requirements for safety, marking and information to be provided by the manufacturer (EN 45502-1:1997)
HRN EN 45502-2-1:2008	Aktivni implantabilni medicinski uređaji – Dio 2-1: Posebni zahtjevi za aktivne implantabilne medicinske uređaje (elektrostimulatore srca) namijenjene liječenju bradiaritmija (EN 45502-2-1:2003)	EN 45502-2-1:2003	Active implantable medical devices – Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) (EN 45502-2-1:2003)
HRN EN 45502-2-2:2008	Aktivni implantabilni medicinski uređaji – Dio 2-2: Posebni zahtjevi za aktivne implantabilne medicinske uređaje namijenjene liječenju tahiaritmija (uključuje implantabilne defibrilatore) (EN 45502-2-2:2008)	EN 45502-2-2:2008	Active implantable medical devices – Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) (EN 45502-2-2:2008)
HRN EN 60601-1:1999	Medicinski električni uređaji – 1. dio: Opći sigurnosni zahtjevi (IEC 60601-1:1988+A1:1991+A2:1995, prilag.; EN 60601-1:1990+A1:1993+A2:1995+A13:1996)	EN 60601-1:1990	Medical electrical equipment – Part 1: General requirements for safety (IEC 60601-1:1988+A1:1991+A2:1995, mod.; EN 60601-1:1990+A1:1993+A2:1995+A13:1996)
HRN EN 60601-1:2008	Medicinski električni uređaji – 1. dio: Opći zahtjevi za osnovnu sigurnost i bitne radne značajke (IEC 60601-1:2005; EN 60601-1:2006)	EN 60601-1:2006	Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005; EN 60601-1:2006)
HRN EN 62304:2008	Programske podrške medicinskih uređaja – Održavanje programske podrške za vrijeme životnog vijeka (IEC 62304:2006; EN 62304:2006)	EN 62304:2006	Medical device software – Software life-cycle processes (IEC 62304:2006; EN 62304:2006)

In vitro dijagnostički medicinski proizvodi

Oznaka hrvatske norme	Naslov hrvatske norme	Oznaka europske norme	Naslov europske norme
HRN EN 375:2008		EN 375:2001	Information supplied by the manufacturer with in vitro diagnostic reagents for professional use (EN 375:2001)
HRN EN 376:2008		EN 376:2002	Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing (EN 376:2002)
HRN EN 556-1:2008		EN 556-1:2001	Sterilization of medical devices – Requirements for medical devices to be designated »STERILE« – Part 1: Requirements for terminally sterilized medical devices (EN 556-1:2001+AC:2006)
HRN EN 556-2:2008		EN 556-2:2003	Sterilization of medical devices – Requirements for medical devices to be designated »STERILE« – Part 2: Requirements for aseptically processed medical devices (EN 556-2:2003)
HRN EN 591:2008		EN 591:2001	Instructions for use for in vitro diagnostic instruments for professional use (EN 591:2001)
HRN EN 592:2008		EN 592:2002	Instructions for use for in vitro diagnostic instruments for self-testing (EN 592:2002)
HRN EN 980:2008		EN 980:2008	Symbols for use in the labelling of medical devices (EN 980:2008)
HRN EN 12286:2008		EN 12286:1998	In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Presentation of reference measurement procedures (EN 12286:1998+A1:2000)
HRN EN 12287:2008		EN 12287:1999	In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Description of reference materials (EN 12287:1999)
HRN EN 12322:2008		EN 12322:1999	In vitro diagnostic medical devices – Culture media for microbiology – Performance criteria for culture media (EN 12322:1999+A1:2001)
HRN EN ISO 13485:2003	Medicinski uređaji – Sustavi upravljanja kvalitetom – Zahtjevi za zakonsku namjenu (ISO 13485:2003; EN ISO 13485:2003)	EN ISO 13485:2003	Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2003; EN ISO 13485:2003)
HRN EN ISO 13485:2003/Ispr.1:2008	Medicinski uređaji – Sustavi upravljanja kvalitetom – Zahtjevi za zakonsku namjenu (EN ISO 13485:2003/AC:2007)	EN ISO 13485:2003/AC:2007	Medical devices – Quality management systems – Requirements for regulatory purposes (EN ISO 13485:2003/AC:2007)
HRN EN 13532:2008		EN 13532:2002	General requirements for in vitro diagnostic medical devices for self-testing (EN 13532:2002)
HRN EN 13612:2008		EN 13612:2002	Performance evaluation of in vitro diagnostic medical devices (EN 13612:2002+AC:2002)
HRN EN 13640:2008		EN 13640:2002	Stability testing of in vitro diagnostic reagents (EN 13640:2002)
HRN EN 13641:2008		EN 13641:2002	Elimination or reduction of risk of infection related to in vitro diagnostic reagents (EN 13641:2002)
HRN EN 13975:2008		EN 13975:2003	Sampling procedures used for acceptance testing of in vitro diagnostic medical devices – Statistical aspects (EN 13975:2003)
HRN EN 14136:2008		EN 14136:2004	Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures (EN 14136:2004)
HRN EN 14254:2008		EN 14254:2004	In vitro diagnostic medical devices – Single-use receptacles for the collection of specimens, other than blood, from humans (EN 14254:2004)
HRN EN 14820:2008		EN 14820:2004	Single-use containers for human venous blood specimen collection (EN 14820:2004)
HRN EN ISO 14937:2005	Sterilizacija proizvoda za zdravstvenu skrb – Opći zahtjevi za značajke sredstva za sterilizaciju i za provedbu, ocjenjivanje i tijek ispitivanja provedbe sterilizacije medicinskih proizvoda (ISO 14937:2000+Cor 1:2003; EN ISO 14937:2000+AC:2003+AC:2005)	EN ISO 14937:2000	Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000+Cor 1:2003; EN ISO 14937:2000+AC:2003+AC:2005)
HRN EN ISO 14971:2009		EN ISO 14971:2007	Medical devices – Application of risk management to medical devices (ISO 14971:2007; EN ISO 14971:2007)
HRN EN ISO 15197:2007	Dijagnostički sustavi ispitivanja in vitro – Zahtjevi za sustave praćenja glukoze u krvi za samoispitivanje šećerne bolesti (ISO 15197:2003; EN ISO 15197:2003+AC:2005)	EN ISO 15197:2003	In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003; EN ISO 15197:2003+AC:2005)
HRN EN ISO 15225:2008		EN ISO 15225:2000	Nomenclature – Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000+Amd 1:2004; EN ISO 15225:2000+A1:2004+A2:2005)
HRN EN ISO 17511:2008		EN ISO 17511:2003	In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003; EN ISO 17511:2003)
HRN EN ISO 18153:2008		EN ISO 18153:2003	In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003; EN ISO 18153:2003)
HRN EN ISO 20776-1:2008		EN ISO 20776-1:2006	Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006; EN ISO 20776-1:2006)
HRN EN 61010-2-101:2004	Sigurnosni zahtjevi za mjernu, upravljačku i laboratorijsku električnu opremu – Dio 2-101: Posebni zahtjevi za in vitro dijagnostičku (IVD) medicinsku opremu (IEC 61010-2-101:2002, preinačena; EN 61010-2-101:2002)	EN 61010-2-101:2002	Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2002, modified; EN 61010-2-101:2002)
HRN EN 61326-2-6:2008	Električna oprema za mjerenje, vođenje i laboratorijsku uporabu – Zahtjevi za elektromagnetsku kompatibilnost (EMC) – Dio 2-6: Posebni zahtjevi – Medicinski uređaji za in vitro dijagnostiku (IEC 61326-2-6:2005+Corr.1:2007; EN 61326-2-6:2006)	EN 61326-2-6:2006	Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2005+Corr.1:2007; EN 61326-2-6:2006)
HRN EN 62304:2008	Programske podrške medicinskih uređaja – Održavanje programske podrške za vrijeme životnog vijeka (IEC 62304:2006; EN 62304:2006)	EN 62304:2006	Medical device software – Software life-cycle processes (IEC 62304:2006; EN 62304:2006)
HRN EN 62366:2008	Medicinski električni uređaji – Primjena prikladnog oblikovanja i konstrukcije medicinskih uređaja (IEC 62366:2007; EN 62366:2008)	EN 62366:2008	Medical devices – Application of usability engineering to medical devices (IEC 62366:2007; EN 62366:2008)

Medicinski proizvodi

Oznaka hrvatske norme	Naslov hrvatske norme	Oznaka europske norme	Naslov europske norme
HRN EN 455-1:2008		EN 455-1:2000	Medical gloves for single use – Part 1: Requirements and testing for freedom from holes (EN 455-1:2000)
HRN EN 455-2:2008		EN 455-2:2000	Medical gloves for single use – Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996) (EN 455-2:2000)
HRN EN 455-3:2008		EN 455-3:2006	Medical gloves for single use – Part 3: Requirements and testing for biological evaluation (EN 455-3:2006)
HRN EN 556-1:2008		EN 556-1:2001	Sterilization of medical devices – Requirements for medical devices to be designated »STERILE« – Part 1: Requirements for terminally sterilized medical devices (EN 556-1:2001+AC:2006)
HRN EN 556-2:2008		EN 556-2:2003	Sterilization of medical devices – Requirements for medical devices to be designated »STERILE« – Part 2: Requirements for aseptically processed medical devices (EN 556-2:2003)
HRN EN 794-3:2004	Plućni ventilatori – 3. dio: Posebni zahtjevi za prijenosne ventilatore za hitne slučajeve (EN 794-3:1998)	EN 794-3:1998	Lung ventilators – Part 3: Particular requirements for emergency and transport ventilators (EN 794-3:1998)
HRN EN 794-3:2004/A1:2008	Ventilatori pluća – 3. dio: Posebni zahtjevi za transportne ventilatore i ventilatore za hitnu pomoć (EN 794-3:1998/A1:2005)	EN 794-3:1998/A1:2005	Lung ventilators – Part 3: Particular requirements for emergency and transport ventilators (EN 794-3:1998/A1:2005)
HRN EN 980:2008		EN 980:2008	Symbols for use in the labelling of medical devices (EN 980:2008)
HRN EN 1041:2008		EN 1041:2008	Information supplied by the manufacturer of medical devices (EN 1041:2008)
HRN EN 1060-1:2008		EN 1060-1:1995	Non-invasive sphygmomanometers – Part 1: General requirements (EN 1060-1:1995+A1:2002)
HRN EN 1060-2:2008		EN 1060-2:1995	Non-invasive sphygmomanometers – Part 2: Supplementary requirements for mechanical sphygmomanometers (EN 1060-2:1995+AC:2002)
HRN EN 1060-3:2008		EN 1060-3:1997	Non-invasive sphygmomanometers – Part 3: Supplementary requirements for electromechanical blood pressure measuring systems (EN 1060-3:1997+A1:2005)
HRN EN 1060-4:2008		EN 1060-4:2004	Non-invasive sphygmomanometers – Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers (EN 1060-4:2004)
HRN EN 1089-3:2008	Prenosive plinske boce – Označivanje plinskih boca (osim UNP) – 3. dio: Označivanje bojom (EN 1089-3:2004)	EN 1089-3:2004	Transportable gas cylinders – Gas cylinder identification (excluding LPG) – Part 3: Colour coding (EN 1089-3:2004)
HRN EN 1282-2:2008	Traheostomijske cijevi – 2. dio: Cijevi za djecu (ISO 5366-3:2001, MOD; EN 1282-2:2005)	EN 1282-2:2005	Tracheostomy tubes – Part 2: Paediatric tubes (ISO 5366-3:2001, MOD; EN 1282-2:2005)
HRN EN 1618:2008		EN 1618:1997	Catheters other than intravascular catheters – Test methods for common properties (EN 1618:1997)
HRN EN 1639:2004	Stomatologija – Medicinske naprave za stomatologiju – Instrumenti (EN 1639:2004)	EN 1639:2004	Dentistry – Medical devices for dentistry – Instruments (EN 1639:2004)
HRN EN 1640:2004	Stomatologija – Medicinske naprave za stomatologiju – Oprema (EN 1640:2004)	EN 1640:2004	Dentistry – Medical devices for dentistry – Equipment (EN 1640:2004)
HRN EN 1641:2004	Stomatologija – Medicinske naprave za stomatologiju – Materijali (EN 1641:2004)	EN 1641:2004	Dentistry – Medical devices for dentistry – Materials (EN 1641:2004)
HRN EN 1642:2008		EN 1642:2004	Dentistry – Medical devices for dentistry – Dental implants (EN 1642:2004)
HRN EN 1707:2008		EN 1707:1996	Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Lock fittings (EN 1707:1996)
HRN EN 1782:2004	Trahealne cijevi i priključci (EN 1782:1998)	EN 1782:1998	Tracheal tubes and connectors (EN 1782:1998)
HRN EN 1789:2008	Medicinski automobili i njihova oprema – Cestovni medicinski automobili (EN 1789:2007)	EN 1789:2007	Medical vehicles and their equipment – Road ambulances (EN 1789:2007)
HRN EN 1820:2008	Zračni baloni za anesteziju (ISO 5362:2000, MOD; EN 1820:2005)	EN 1820:2005	Anaesthetic reservoir bags (ISO 5362:2000, MOD; EN 1820:2005)
HRN EN 1865:2004	Specifikacije za nosila i drugu opremu za postupanje s bolesnikom koja se upotrebljavaju u cestovnome medicinskom automobilu (EN 1865:1999)	EN 1865:1999	Specifications for stretchers and other patient handling equipment used in road ambulances (EN 1865:1999)
HRN EN 1970:2008		EN 1970:2000	Adjustable beds for disabled persons – Requirements and test methods (EN 1970:2000+A1:2005)
HRN EN 1985:2008		EN 1985:1998	Walking aids – General requirements and test methods (EN 1985:1998)
HRN EN ISO 3826-2:2008		EN ISO 3826-2:2008	Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008; EN ISO 3826-2:2008)
HRN EN ISO 3826-3:2008		EN ISO 3826-3:2007	Plastics collapsible containers for human blood and blood components – Part 3: Blood bag systems with integrated features (ISO 3826-3:2006; EN ISO 3826-3:2007)
HRN EN ISO 4074:2008		EN ISO 4074:2002	Natural latex rubber condoms – Requirements and test methods (ISO 4074:2002+Cor 1:2003+Cor 2:2008; EN ISO 4074:2002+AC:2004+AC:2008)
HRN EN ISO 4135:2008	Anestetička i respiracijska oprema – Terminološki rječnik (ISO 4135: 2001; EN ISO 4135:2001)	EN ISO 4135:2001	Anaesthetic and respiratory equipment – Vocabulary (ISO 4135: 2001; EN ISO 4135:2001)
HRN EN ISO 5356-1:2008	Anestetička i respiracijska oprema – Stožasti priključci – 1. dio: Stožasti utikači i utičnice (ISO 5356-1:2004; EN ISO 5356-1:2004)	EN ISO 5356-1:2004	Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets (ISO 5356-1:2004; EN ISO 5356-1:2004)
HRN EN ISO 5356-2:2008	Anestetička i respiracijska oprema – Stožasti priključci – 2. dio: Priključci na navoj veće nosivosti (ISO 5356-2:2006; EN ISO 5356-2:2007)	EN ISO 5356-2:2007	Anaesthetic and respiratory equipment – Conical connectors – Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2006; EN ISO 5356-2:2007)
HRN EN ISO 5359:2008	Niskotlačni cjevovodni sklop za primjenu s medicinskim plinovima (ISO 5359:2008; EN ISO 5359:2008)	EN ISO 5359:2008	Low-pressure hose assemblies for use with medical gases (ISO 5359:2008; EN ISO 5359:2008)
HRN EN ISO 7396-1:2008	Cjevovodni sustavi za medicinske plinove – 1. dio: Cjevovodni sustavi za komprimirane medicinske plinove i vakuum (ISO 7396-1:2007; EN ISO 7396-1:2007)	EN ISO 7396-1:2007	Medical gas pipeline systems – Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007; EN ISO 7396-1:2007)
HRN EN ISO 7396-2:2008	Cjevovodni sustavi za medicinske plinove – 2. dio: Sustavi za odstranjivanje anestetičkih plinova (ISO 7396-2:2007; EN ISO 7396-2:2007)	EN ISO 7396-2:2007	Medical gas pipeline systems – Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007; EN ISO 7396-2:2007)
HRN EN ISO 7886-3:2008		EN ISO 7886-3:2005	Sterile hypodermic syringes for single use – Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005; EN ISO 7886-3:2005)
HRN EN ISO 7886-4:2008		EN ISO 7886-4:2006	Sterile hypodermic syringes for single use – Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006; EN ISO 7886-4:2006)
HRN EN ISO 8536-4:2008		EN ISO 8536-4:2007	Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007; EN ISO 8536-4:2007)
HRN EN ISO 9360-1:2004	Anestetička i respiracijska oprema – Izmjenjivači topline i vlage (HMEs) za ovlaživanje dišnih plinova za ljude – 1. dio: HMEs za upotrebu s minimalnim volumenom udisaja od 250 ml (ISO 9360-1:2000; EN ISO 9360-1:2009)	EN ISO 9360-1:2009	Anaesthetic and respiratory equipment – Heat and moisture exchangers (HMEs) for humidifying respired gases in humans – Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000; EN ISO 9360-1:2009)
HRN EN ISO 9360-2:2004	Anestetička i respiracijska oprema – Izmjenjivači topline i vlage (HMEs) za ovlaživanje dišnih plinova za ljude – 2. dio: HMEs za upotrebu kod trahetomiranih bolesnika s minimalnim volumenom udisaja od 250 ml (ISO 9360-2:2001; EN ISO 9360-2:2009)	EN ISO 9360-2:2009	Anaesthetic and respiratory equipment – Heat and moisture exchangers (HMEs) for humidifying respired gases in humans – Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001; EN ISO 9360-2:2009)
HRN EN ISO 10328:2008		EN ISO 10328:2006	Prosthetics – Structural testing of lower-limb prostheses – Requirements and test methods (ISO 10328:2006; EN ISO 10328:2006)
HRN EN ISO 10524-1:2008	Regulatori tlaka za uporabu s medicinskim plinovima – 1. dio: Regulatori tlaka i regulatori tlaka s uređajima za mjerenje protoka (ISO 10524-1:2006; EN ISO 10524-1:2006)	EN ISO 10524-1:2006	Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006; EN ISO 10524-1:2006)
HRN EN ISO 10524-2:2008	Regulatori tlaka za uporabu s medicinskim plinovima – 2. dio: Regulatori tlaka baterija boca i tlaka središnjeg sustava opskrbe (ISO 10524-2:2005; EN ISO 10524-2:2006)	EN ISO 10524-2:2006	Pressure regulators for use with medical gases – Part 2: Manifold and line pressure regulators (ISO 10524-2:2005; EN ISO 10524-2:2006)
HRN EN ISO 10524-3:2008	Regulatori tlaka za uporabu s medicinskim plinovima – 3. dio: Regulatori tlaka integrirani s ventilima na boci (ISO 10524-3:2005; EN ISO 10524-3:2006)	EN ISO 10524-3:2006	Pressure regulators for use with medical gases – Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005; EN ISO 10524-3:2006)
HRN EN ISO 10524-4:2008	Regulatori pritiska za uporabu s medicinskim plinovima – 4. dio: Niskotlačni regulatori (ISO 10524-4:2008; EN ISO 10524-4:2008)	EN ISO 10524-4:2008	Pressure regulators for use with medical gases – Part 4: Low-pressure regulators (ISO 10524-4:2008; EN ISO 10524-4:2008)
HRN EN ISO 10535:2008		EN ISO 10535:2006	Hoists for the transfer of disabled persons – Requirements and test methods (ISO 10535:2006; EN ISO 10535:2006)
HRN EN ISO 10993-7:2008		EN ISO 10993-7:2008	Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008; EN ISO 10993-7:2008)
HRN EN ISO 11135-1:2008		EN ISO 11135-1:2007	Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007; EN ISO 11135-1:2007)
HRN EN ISO 11137-1:2007	Sterilizacija proizvoda za zdravstvenu skrb – Zračenje – 1. dio: Zahtjevi za razvoj, vrednovanje i kontrolu provedbe sterilizacijskog postupka za medicinske proizvode (ISO 11137-1:2006; EN ISO 11137-1:2006)	EN ISO 11137-1:2006	Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006; EN ISO 11137-1:2006)
HRN EN ISO 11137-2:2008		EN ISO 11137-2:2007	Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01; EN ISO 11137-2:2007)
HRN EN ISO 11137-2:2008/AC:2009		EN ISO 11137-2:2007/AC:2009	Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose (ISO 11137-2:2006/Cor 1:2009; EN ISO 11137-2:2007/AC:2009)
HRN EN ISO 11607-2:2008		EN ISO 11607-2:2006	Packaging for terminally sterilized medical devices – Part 2: Requirements for forming, sealing and assembly processes (ISO 11607-2:2006; EN ISO 11607-2:2006)
HRN EN ISO 11737-1:2006	Sterilizacija medicinskoga pribora – Mikrobiološke metode – 1. dio: Određivanje vrste i broja mikroorganizama na proizvodima (ISO 11737-1:2006; EN ISO 11737-1:2006)	EN ISO 11737-1:2006	Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006; EN ISO 11737-1:2006)
HRN EN ISO 11990:2008	Optika i optički instrumenti – Laseri i pridružena oprema – Utvrđivanje otpornosti trahealnih intubacijskih cijevi na lasersko zračenje (ISO 11990:2003; EN ISO 11990:2003)	EN ISO 11990:2003	Optics and optical instruments – Lasers and laser-related equipment – Determination of laser resistance of tracheal tube shafts (ISO 11990:2003; EN ISO 11990:2003)
HRN EN 12182:2008		EN 12182:1999	Technical aids for disabled persons – General requirements and test methods (EN 12182:1999)
HRN EN 12342:2004	Cijevi za disanje namijenjene za uporabu s anestetičkim uređajima i ventilatorima (EN 12342:1998)	EN 12342:1998	Breathing tubes intended for use with anaesthetic apparatus and ventilators (EN 12342:1998)
HRN EN 12470-5:2005	Medicinski termometri – 5. dio: Zahtjevi za infracrvene ušne termometre (za mjerenje najviše temperature ljudskoga tijela) (EN 12470-5:2003)	EN 12470-5:2003	Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with maximum device) (EN 12470-5:2003)
HRN EN ISO 13485:2003	Medicinski uređaji – Sustavi upravljanja kvalitetom – Zahtjevi za zakonsku namjenu (ISO 13485:2003; EN ISO 13485:2003)	EN ISO 13485:2003	Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2003; EN ISO 13485:2003)
HRN EN ISO 13485:2003/Ispr.1:2008	Medicinski uređaji – Sustavi upravljanja kvalitetom – Zahtjevi za zakonsku namjenu (EN ISO 13485:2003/AC:2007)	EN ISO 13485:2003/AC:2007	Medical devices – Quality management systems – Requirements for regulatory purposes (EN ISO 13485:2003/AC:2007)
HRN EN 13544-1:2008	Oprema za respiracijsku terapiju – 1. dio: Sustavi za stvaranje aerosola i njihovi dijelovi (EN 13544-1:2007)	EN 13544-1:2007	Respiratory therapy equipment – Part 1: Nebulizing systems and their components (EN 13544-1:2007)
HRN EN 13544-2:2004	Oprema za respiracijsku terapiju – 2. dio: Cijevi i spojevi (EN 13544-2:2002)	EN 13544-2:2002	Respiratory therapy equipment – Part 2: Tubing and connectors (EN 13544-2:2002)
HRN EN 13544-3:2004	Oprema za respiracijsku terapiju – 3. dio: Uređaji za obogaćivanje zraka kisikom (EN 13544-3:2001)	EN 13544-3:2001	Respiratory therapy equipment – Part 3: Air entrainment devices (EN 13544-3:2001)
HRN EN 13624:2005	Kemijski dezinficijensi i antiseptici – Kvantitativni suspenzijski test za vrednovanje fungicidne djelotvornosti kemijskih dezinficijensa za instrumente koji se upotrebljavaju u medicini – Metoda i zahtjevi testiranja (faza 2, korak 1) (EN 13624:2003)	EN 13624:2003	Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area – Test method and requirements (phase 2, step 1) (EN 13624:2003)
HRN EN 13726-1:2008		EN 13726-1:2002	Test methods for primary wound dressings – Part 1: Aspects of absorbency (EN 13726-1:2002)
HRN EN 13726-2:2008		EN 13726-2:2002	Test methods for primary wound dressings – Part 2: Moisture vapour transmission rate of permeable film dressings (EN 13726-2:2002)
HRN EN 13727:2005	Kemijski dezinficijensi i antiseptici – Kvantitativni suspenzijski test za vrednovanje baktericidne djelotvornosti kemijskih dezinficijensa za instrumente koji se upotrebljavaju u medicini – Metoda i zahtjevi testiranja (faza 2, korak 1) (EN 13727:2003)	EN 13727:2003	Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area – Test method and requirements (phase 2, step 1) (EN 13727:2003)
HRN EN 13795-1:2008		EN 13795-1:2002	Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment – Part 1: General requirements for manufacturers, processors and products (EN 13795-1:2002)
HRN EN 13795-2:2008		EN 13795-2:2004	Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment – Part 2: Test methods (EN 13795-2:2004)
HRN EN 13795-3:2008		EN 13795-3:2006	Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment – Part 3: Performance requirements and performance levels (EN 13795-3:2006)
HRN EN 13824:2007	Sterilizacija medicinskih proizvoda – Sterilna priprema tekućih medicinskih proizvoda – Zahtjevi (EN 13824:2004)	EN 13824:2004	Sterilization of medical devices – Aseptic processing of liquid medical devices – Requirements (EN 13824:2004)
HRN EN 13976-1:2008	Sustavi za spašavanje – Transport inkubatora – 1. dio: Uvjeti povezivanja (EN 13976-1:2003)	EN 13976-1:2003	Rescue systems – Transportation of incubators – Part 1: Interface conditions (EN 13976-1:2003)
HRN EN 13976-2:2008	Sustavi za spašavanje – Transport inkubatora – 2. dio: Zahtjevi za sustav (EN 13976-2:2003+AC:2004)	EN 13976-2:2003	Rescue systems – Transportation of incubators – Part 2: System requirements (EN 13976-2:2003+AC:2004)
HRN EN 14079:2008		EN 14079:2003	Non-active medical devices – Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze (EN 14079:2003)
HRN EN ISO 14155-1:2008		EN ISO 14155-1:2003	Clinical investigation of medical devices for human subjects – Part 1: General requirements (ISO 14155-1:2003; EN ISO 14155-1:2003)
HRN EN ISO 14155-2:2008		EN ISO 14155-2:2003	Clinical investigation of medical devices for human subjects – Part 2: Clinical investigation plans (ISO 14155-2:2003; EN ISO 14155-2:2003)
HRN EN ISO 14160:2008		EN ISO 14160:1998	Sterilization of single-use medical devices incorporating materials of animal origin – Validation and routine control of sterilization by liquid chemical sterilants (ISO 14160:1998; EN ISO 14160:1998)
HRN EN 14348:2005	Kemijski dezinficijensi i antiseptici – Kvantitativni suspenzijski test za vrednovanje mikobaktericidne djelotvornosti kemijskih dezinficijenasa koji se upotrebljavaju u medicini, uključujući dezinficijense za instrumente – Metoda testiranja i zahtjevi (faza 2/korak 1) (EN 14348:2005)	EN 14348:2005	Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants – Test methods and requirements (phase 2, step 1) (EN 14348:2005)
HRN EN 14561:2006	Kemijski dezinficijensi i antiseptici – Kvantitativni test na nosaču za vrednovanje baktericidne djelotvornosti za instrumente koji se upotrebljavaju u medicini – Metoda testiranja i zahtjevi (faza 2/korak 2) (EN 14561:2006)	EN 14561:2006	Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area – Test methods and requirements (phase 2, step 2) (EN 14561:2006)
HRN EN 14562:2006	Kemijski dezinficijensi i antiseptici – Kvantitativni test na nosaču za vrednovanje fungicidne ili djelotvornosti na kvasce za instrumente koji se upotrebljavaju u medicini – Metoda testiranja i zahtjevi (faza 2/korak 2) (EN 14562:2006)	EN 14562:2006	Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area – Test methods and requirements (phase 2, step 2) (EN 14562:2006)
HRN EN 14563:2008	Kemijski dezinficijensi i antiseptici – Kvantitativni test na nosaču za vrednovanje mikobaktericidne ili tuberkulocidne djelotvornosti za instrumente koji se upotrebljavaju u medicini – Metoda testiranja i zahtjevi (faza 2/korak 2) (EN 14563:2008)	EN 14563:2008	Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area – Test methods and requirements (phase 2, step 2) (EN 14563:2008)
HRN EN 14683:2008		EN 14683:2005	Surgical masks – Requirements and test methods (EN 14683:2005)
HRN EN 14931:2008		EN 14931:2006	Pressure vessels for human occupancy (PVHO) – Multi-place pressure chamber systems for hyperbaric therapy – Performance, safety requirements and testing (EN 14931:2006)
HRN EN ISO 14937:2005	Sterilizacija proizvoda za zdravstvenu skrb – Opći zahtjevi za značajke sredstva za sterilizaciju i za provedbu, ocjenjivanje i tijek ispitivanja provedbe sterilizacije medicinskih proizvoda (ISO 14937:2000+Cor 1:2003; EN ISO 14937:2000+AC:2003+AC:2005)	EN ISO 14937:2000	Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000+Cor 1:2003; EN ISO 14937:2000+AC:2003+AC:2005)
HRN EN ISO 14971:2009		EN ISO 14971:2007	Medical devices – Application of risk management to medical devices (ISO 14971:2007; EN ISO 14971:2007)
HRN EN ISO 15001:2008	Anestetička i respiracijska oprema – Kompatibilnost s kisikom (ISO 15001:2003; EN ISO 15001:2004)	EN ISO 15001:2004	Anaesthetic and respiratory equipment – Compatibility with oxygen (ISO 15001:2003; EN ISO 15001:2004)
HRN EN ISO 15225:2008		EN ISO 15225:2000	Nomenclature – Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000+Amd 1:2004; EN ISO 15225:2000+A1:2004+A2:2005)
HRN EN 15424:2008		EN 15424:2007	Sterilization of medical devices – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (EN 15424:2007)
HRN EN 15546-1:2008		EN 15546-1:2008	Small bore connectors for liquids and gases in healthcare applications – Part 1: General requirements (EN 15546-1:2008)
HRN EN ISO 15747:2008		EN ISO 15747:2005	Plastics containers for intravenous injection (ISO 15747:2003; EN ISO 15747:2005)
HRN EN ISO 16061:2009		EN ISO 16061:2008	Instrumentation for use in association with non-active surgical implants – General requirements (ISO 16061:2008; EN ISO 16061:2008)
HRN EN ISO 16201:2008		EN ISO 16201:2006	Technical aids for disabled persons – Environmental control systems for daily living (ISO 16201:2006; EN ISO 16201:2006)
HRN EN ISO 17664:2008		EN ISO 17664:2004	Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004; EN ISO 17664:2004)
HRN EN ISO 17665-1:2008		EN ISO 17665-1:2006	Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006; EN ISO 17665-1:2006)
HRN EN ISO 18779:2008	Medicinski uređaji za čuvanje kisika i mješavina kisika – Posebni zahtjevi (ISO 18779:2005; EN ISO 18779:2005)	EN ISO 18779:2005	Medical devices for conserving oxygen and oxygen mixtures – Particular requirements (ISO 18779:2005; EN ISO 18779:2005)
HRN EN ISO 19054:2008	Pružni sustavi za učvršćenje medicinskih uređaja (ISO 19054:2005; EN ISO 19054:2006)	EN ISO 19054:2006	Rail systems for supporting medical equipment (ISO 19054:2005; EN ISO 19054:2006)
HRN EN 20594-1:2008		EN 20594-1:1993	Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 1: General requirements (ISO 594-1:1986; EN 20594-1:1993+A1:1997+AC:1996)
HRN EN ISO 21171:2008		EN ISO 21171:2006	Medical gloves – Determination of removable surface powder (ISO 21171:2006; EN ISO 21171:2006)
HRN EN ISO 21649:2008		EN ISO 21649:2006	Needle-free injectors for medical use – Requirements and test methods (ISO 21649:2006; EN ISO 21649:2006)
HRN EN ISO 21969:2008	Visokotlačni fleksibilni priključci za uporabu s medicinskim plinskim sustavima (ISO 21969:2005; EN ISO 21969:2006)	EN ISO 21969:2006	High-pressure flexible connections for use with medical gas systems (ISO 21969:2005; EN ISO 21969:2006)
HRN EN ISO 22442-1:2008		EN ISO 22442-1:2007	Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2007; EN ISO 22442-1:2007)
HRN EN ISO 22442-2:2008		EN ISO 22442-2:2007	Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007; EN ISO 22442-2:2007)
HRN EN ISO 22442-3:2008		EN ISO 22442-3:2007	Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007; EN ISO 22442-3:2007)
HRN EN ISO 22523:2008		EN ISO 22523:2006	External limb prostheses and external orthoses – Requirements and test methods (ISO 22523:2006; EN ISO 22523:2006)
HRN EN ISO 22610:2008		EN ISO 22610:2006	Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment – Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006; EN ISO 22610:2006)
HRN EN ISO 22612:2008		EN ISO 22612:2005	Clothing for protection against infectious agents – Test method for resistance to dry microbial penetration (ISO 22612:2005; EN ISO 22612:2005)
HRN EN ISO 22675:2008		EN ISO 22675:2006	Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2006; EN ISO 22675:2006)
HRN EN ISO 23328-1:2008	Sustav respiratornih filtara za anestetičku i respiracijsku uporabu – 1. dio: Ispitni postupci sa solima za procjenu kakvoće filtra (ISO 23328-1:2003; EN ISO 23328-1:2008)	EN ISO 23328-1:2008	Breathing system filters for anaesthetic and respiratory use – Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003; EN ISO 23328-1:2008)
HRN EN 27740:2008		EN 27740:1992	Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985; EN 27740:1992+A1:1997+AC:1996)
HRN EN 60118-13:2008	Elektroakustika – Slušna pomagala – 13. dio: Elektromagnetska kompatibilnost (EMC) (IEC 60118-13:2004; EN 60118-13:2005)	EN 60118-13:2005	Electroacoustics – Hearing aids – Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2004; EN 60118-13:2005)
HRN EN 60522:2000	Određivanje veličine trajne filtracije sklopova rendgenskih cijevi (IEC 60522:1999; EN 60522:1999)	EN 60522:1999	Determination of the permanent filtration of X-ray tube assemblies (IEC 60522:1999; EN 60522:1999)
HRN EN 60580:2003	Medicinska električna oprema – Mjerila radioaktivne ozračenosti prostora (IEC 60580:2000; EN 60580:2000)	EN 60580:2000	Medical electrical equipment – Dose area product meters (IEC 60580:2000; EN 60580:2000)
HRN EN 60601-1-10:2008	Medicinski električni uređaji – Dio 1-10: Opći zahtjevi za osnovnu sigurnost i bitne radne značajke – Popratna norma: Zahtjevi za razvoj fizioloških kontrolera u zatvorenoj petlji (IEC 60601-1-10:2007; EN 60601-1-10:2008)	EN 60601-1-10:2008	Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007; EN 60601-1-10:2008)
HRN EN 60601-1-1:2003	Medicinska električna oprema – Dio 1-1: Opći zahtjevi za sigurnost – Popratna norma: Sigurnosni zahtjevi za medicinske električne sustave (IEC 60601-1-1:2000; EN 60601-1-1:2001)	EN 60601-1-1:2001	Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000; EN 60601-1-1:2001)
HRN EN 60601-1:1999	Medicinski električni uređaji – 1. dio: Opći sigurnosni zahtjevi (IEC 60601-1:1988+A1:1991+A2:1995, prilag.; EN 60601-1:1990+A1:1993+A2:1995+A13:1996)	EN 60601-1:1990	Medical electrical equipment – Part 1: General requirements for safety (IEC 60601-1:1988+A1:1991+A2:1995, mod.; EN 60601-1:1990+A1:1993+A2:1995+A13:1996)
HRN EN 60601-1:2008	Medicinski električni uređaji – 1. dio: Opći zahtjevi za osnovnu sigurnost i bitne radne značajke (IEC 60601-1:2005; EN 60601-1:2006)	EN 60601-1:2006	Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005; EN 60601-1:2006)
HRN EN 60601-1-2:2003	Medicinska električna oprema – Dio 1-2: Opći zahtjevi za sigurnost – Popratna norma: Elektromagnetska kompatibilnost – Zahtjevi i ispitivanja (IEC 60601-1-2:2001; EN 60601-1-2:2001)	EN 60601-1-2:2001	Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests (IEC 60601-1-2:2001; EN 60601-1-2:2001)
HRN EN 60601-1-2:2003/A1:2008	Medicinski električni uređaji – Dio 1-2: Opći zahtjevi za sigurnost – Popratna norma: Elektromagnetska kompatibilnost – Zahtjevi i ispitivanja (IEC 60601-1-2:2001/am1:2004; EN 60601-1-2:2001/A1:2006)	EN 60601-1-2:2001/A1:2006	Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests (IEC 60601-1-2:2001/am1:2004; EN 60601-1-2:2001/A1:2006)
HRN EN 60601-1-2:2008	Medicinska električna oprema – Dio 1-2: Opći zahtjevi za osnovnu sigurnost i bitne radne značajke – Popratna norma: Elektromagnetska kompatibilnost – Zahtjevi i ispitivanja (IEC 60601-1-2:2007, MOD; EN 60601-1-2:2007)	EN 60601-1-2:2007	Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests (IEC 60601-1-2:2007, MOD; EN 60601-1-2:2007)
HRN EN 60601-1-3:1999	Medicinski električni uređaji – 1. dio: Opći sigurnosni zahtjevi – 3: Popratna norma: Opći zahtjevi za zaštitu od zračenja u dijagnostičkoj opremi s X-zračenjem (IEC 60601-1-3:1994; EN 60601-1-3:1994)	EN 60601-1-3:1994	Medical electrical equipment – Part 1: General requirements for safety – 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:1994; EN 60601-1-3:1994)
HRN EN 60601-1-3:2008	Medicinski električni uređaji – Dio 1-3: Opći zahtjevi za osnovnu sigurnost i bitne radne značajke – Popratna norma: Zaštitu od zračenja u dijagnostičkoj rendgenskoj opremi (IEC 60601-1-3:2008; EN 60601-1-3:2008)	EN 60601-1-3:2008	Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008; EN 60601-1-3:2008)
HRN EN 60601-1-4:1999	Medicinski električni uređaji – 1. dio: Opći sigurnosni zahtjevi – 4: Popratna norma: Električni medicinski sustavi koji se mogu programirati (IEC 60601-1-4:1996; EN 60601-1-4:1996)	EN 60601-1-4:1996	Medical electrical equipment – Part 1: General requirements for safety – 4. Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996; EN 60601-1-4:1996)
HRN EN 60601-1-4:1999/A1:2003	Medicinska električna oprema – Dio 1-4: Opći zahtjevi za sigurnost – Popratna norma: Programabilni elektromedicinski sustavi (IEC 60601-1-4:1996/am1:1999; EN 60601-1-4:1996/A1:1999)	EN 60601-1-4:1996/A1:1999	Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996/am1:1999; EN 60601-1-4:1996/A1:1999)
HRN EN 60601-1-6:2008	Medicinski električni uređaji – Dio 1-6: Opći zahtjevi za sigurnost – Popratna norma: Upotrebljivost (IEC 60601-1-6:2004; EN 60601-1-6:2004)	EN 60601-1-6:2004	Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard: Usability (IEC 60601-1-6:2004; EN 60601-1-6:2004)
HRN EN 60601-1-6:2009	Medicinski električni uređaji – Dio 1-6: Opći zahtjevi za osnovnu sigurnost i bitne radne značajke – Popratna norma: Upotrebljivost (IEC 60601-1-6:2006; EN 60601-1-6:2007)	EN 60601-1-6:2007	Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability (IEC 60601-1-6:2006; EN 60601-1-6:2007)
HRN EN 60601-1-8:2008	Medicinski električni uređaji – Dio 1-8: Opći zahtjevi za sigurnost – Popratna norma: Opći zahtjevi, ispitivanja i smjernice za alarmne sustave u medicinskim električnim uređajima i opremi (IEC 60601-1-8:2003+am1:2006; EN 60601-1-8:2004+A1:2006+Corr.:2006)	EN 60601-1-8:2004	Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2003+am1:2006; EN 60601-1-8:2004+A1:2006+Corr.:2006)
HRN EN 60601-1-8:2009	Medicinski električni uređaji – Dio 1-8: Opći zahtjevi za osnovnu sigurnost i bitne radne značajke – Popratna norma: Opći zahtjevi, ispitivanja i smjernice za alarmne sustave u medicinskim električnim uređajima i opremi (IEC 60601-1-8:2006; EN 60601-1-8:2007)	EN 60601-1-8:2007	Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006; EN 60601-1-8:2007)
HRN EN 60601-2-10:2003	Medicinska električna oprema – Dio 2-10: Posebni zahtjevi za sigurnost stimulatora živaca i mišića (IEC 60601-2-10:1987+am1:2001+am1:2001/Corr.1:2002; EN 60601-2-10:2000+A1:2001)	EN 60601-2-10:2000	Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators (IEC 60601-2-10:1987+am1:2001+am1:2001/Corr.1:2002; EN 60601-2-10:2000+A1:2001)
HRN EN 60601-2-11:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za terapijsku opremu koja primjenjuje gama-zrake (IEC 60601-2-11:1997; EN 60601-2-11:1997)	EN 60601-2-11:1997	Medical electrical equipment – Part 2: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997; EN 60601-2-11:1997)
HRN EN 60601-2-11:1999/A1:2008	Medicinski električni uređaji – Dio 2-11: Posebni zahtjevi za sigurnost terapijske opreme s gama zrakama (IEC 60601-2-11:1997/am1:2004; EN 60601-2-11:1997/A1:2004)	EN 60601-2-11:1997/A1:2004	Medical electrical equipment – Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997/am1:2004; EN 60601-2-11:1997/A1:2004)
HRN EN 60601-2-1:2000	Medicinski električni uređaji – Dio 2-1: Posebni zahtjevi za sigurnost elektronskih akceleratora u području od 1 MeV do 50 MeV (IEC 60601-2-1:1998; EN 60601-2-1:1998)	EN 60601-2-1:1998	Medical electrical equipment – Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998; EN 60601-2-1:1998)
HRN EN 60601-2-1:2000/A1:2003	Medicinska električna oprema – Dio 2-1: Posebni zahtjevi za sigurnost elektronskih akceleratora u području od 1 MeV do 50 MeV (IEC 60601-2-1:1998/am1:2002; EN 60601-2-1:1998/A1:2002)	EN 60601-2-1:1998/A1:2002	Medical electrical equipment – Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998/am1:2002; EN 60601-2-1:1998/A1:2002)
HRN EN 60601-2-12:2008	Medicinski električni uređaji – Dio 2-12: Posebni zahtjevi za sigurnost plućnih ventilatora – Ventilatori za intenzivnu njegu (IEC 60601-2-12:2001; EN 60601-2-12:2006)	EN 60601-2-12:2006	Medical electrical equipment – Part 2-12: Particular requirements for the safety of lung ventilators – Critical care ventilators (IEC 60601-2-12:2001; EN 60601-2-12:2006)
HRN EN 60601-2-13:2008	Medicinski električni uređaji – Dio 2-13: Posebni zahtjevi za sigurnost i bitne radne značajke anestezijskih sustava (IEC 60601-2-13:2003+am1:2006; EN 60601-2-13:2006+A1:2007)	EN 60601-2-13:2006	Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (IEC 60601-2-13:2003+am1:2006; EN 60601-2-13:2006+A1:2007)
HRN EN 60601-2-16:2000	Medicinski električni uređaji – Dio 2-16: Posebni zahtjevi za sigurnost uređaja za hemodijalizu, hemodijafiltriranje i hemofiltriranje (IEC 60601-2-16:1998; EN 60601-2-16:1998+Corr.1:1999)	EN 60601-2-16:1998	Medical electrical equipment – Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998; EN 60601-2-16:1998+Corr.1:1999)
HRN EN 60601-2-17:2008	Medicinski električni uređaji – Dio 2-17: Posebni zahtjevi za sigurnost automatski kontrolirane opreme za brahiterapiju s naknadnim punjenjem (IEC 60601-2-17:2004; EN 60601-2-17:2004)	EN 60601-2-17:2004	Medical electrical equipment – Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004; EN 60601-2-17:2004)
HRN EN 60601-2-18:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za endoskopijske uređaje (IEC 60601-2-18:1996; EN 60601-2-18:1996)	EN 60601-2-18:1996	Medical electrical equipment – Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996; EN 60601-2-18:1996)
HRN EN 60601-2-18:1999/A1:2003	Medicinska električna oprema – 2. dio: Posebni zahtjevi za sigurnost endoskopske opreme – Dodatak za poništenje podtočke 56.3 c), te raznih amandmana (IEC 60601-2-18:1996/am1:2000; EN 60601-2-18:1996/A1:2000)	EN 60601-2-18:1996/A1:2000	Medical electrical equipment – Part 2: Particular requirements for the safety of endoscopic equipment – Addition of an exclusion from subclause 56.3 c) and various amendments (IEC 60601-2-18:1996/am1:2000; EN 60601-2-18:1996/A1:2000)
HRN EN 60601-2-19:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za dječje inkubatore (IEC 60601-2-19:1990+am1:1996; EN 60601-2-19:1996+A1:1996)	EN 60601-2-19:1996	Medical electrical equipment – Part 2: Particular requirements for the safety of baby incubators (IEC 60601-2-19:1990+am1:1996; EN 60601-2-19:1996+A1:1996)
HRN EN 60601-2-20:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za prijevozne inkubatore (IEC 60601-2-20:1990+am1:1996; EN 60601-2-20:1996)	EN 60601-2-20:1996	Medical electrical equipment – Part 2: Particular requirements for the safety of transport incubators (IEC 60601-2-20:1990+am1:1996; EN 60601-2-20:1996)
HRN EN 60601-2-21:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za grijače djece koji griju zračenjem (IEC 60601-2-21:1994+am1:1996; EN 60601-2-21:1994+A1:1996)	EN 60601-2-21:1994	Medical electrical equipment – Part 2: Particular requirements for the safety of infant radiant warmers (IEC 60601-2-21:1994+am1:1996; EN 60601-2-21:1994+A1:1996)
HRN EN 60601-2-2:2003	Medicinska električna oprema – Dio 2-2: Posebni zahtjevi za sigurnost visokofrekvencijske kirurške opreme (IEC 60601-2-2:1998; EN 60601-2-2:2000)	EN 60601-2-2:2000	Medical electrical equipment – Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:1998; EN 60601-2-2:2000)
HRN EN 60601-2-2:2008	Medicinski električni uređaji – Dio 2-2: Posebni zahtjevi za sigurnost visokofrekvencijskih kirurških uređaja (IEC 60601-2-2:2006; EN 60601-2-2:2007)	EN 60601-2-2:2007	Medical electrical equipment – Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:2006; EN 60601-2-2:2007)
HRN EN 60601-2-22:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za dijagnostičke i terapijske laserske uređaje (IEC 60601-2-22:1995; EN 60601-2-22:1996)	EN 60601-2-22:1996	Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995; EN 60601-2-22:1996)
HRN EN 60601-2-23:2003	Medicinska električna oprema – Dio 2-23: Posebni zahtjevi za sigurnost, uključivo i bitne zahtjeve, opreme za transkutano nadziranje parcijalnoga tlaka (IEC 60601-2-23:1999; EN 60601-2-23:2000)	EN 60601-2-23:2000	Medical electrical equipment – Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:1999; EN 60601-2-23:2000)
HRN EN 60601-2-24:2000	Medicinski električni uređaji – Dio 2-24: Posebni zahtjevi za sigurnost infuzijskih crpka i njihovih kontrolera (IEC 60601-2-24:1998; EN 60601-2-24:1998)	EN 60601-2-24:1998	Medical electrical equipment – Part 2-24: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998; EN 60601-2-24:1998)
HRN EN 60601-2-25:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za elektrokardiografe (IEC 60601-2-25:1993; EN 60601-2-25:1995)	EN 60601-2-25:1995	Medical electrical equipment – Part 2: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993; EN 60601-2-25:1995)
HRN EN 60601-2-25:1999/A1:2003	Medicinska električna oprema – Dio 2-25: Posebni zahtjevi za sigurnost elektrokardiografa (IEC 60601-2-25:1993/am1:1999; EN 60601-2-25:1995/A1:1999)	EN 60601-2-25:1995/A1:1999	Medical electrical equipment – Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993/am1:1999; EN 60601-2-25:1995/A1:1999)
HRN EN 60601-2-26:2003	Medicinska električna oprema – Dio 2-26: Posebni zahtjevi za sigurnost elektroencefalografa (IEC 60601-2-26:2002; EN 60601-2-26:2003)	EN 60601-2-26:2003	Medical electrical equipment – Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:2002; EN 60601-2-26:2003)
HRN EN 60601-2-27:2008	Medicinski električni uređaji – Dio 2-27: Posebni zahtjevi za sigurnost, uključujući bitne radne značajke elektrokardiografskih uređaja za nadzor (IEC 60601-2-27:2005; EN 60601-2-27:2006+Corr.:2006)	EN 60601-2-27:2006	Medical electrical equipment – Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005; EN 60601-2-27:2006+Corr.:2006)
HRN EN 60601-2-28:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za sklopove izvora X-zraka i sklopove medicinskih dijagnostičkih cijevi za X-zračenje (IEC 60601-2-28:1993; EN 60601-2-28:1993)	EN 60601-2-28:1993	Medical electrical equipment – Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:1993; EN 60601-2-28:1993)
HRN EN 60601-2-29:2000	Medicinski električni uređaji – Dio 2-29: Posebni zahtjevi za sigurnost radioterapijskih simulatora (IEC 60601-2-29:1999; EN 60601-2-29:1999)	EN 60601-2-29:1999	Medical electrical equipment – Part 2-29: Particular requirements for the safety of radiotherapy simulators (IEC 60601-2-29:1999; EN 60601-2-29:1999)
rpHRN EN 60601-2-29		EN 60601-2-29:2008	Medical electrical equipment -- Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008; EN 60601-2-29:2008)
HRN EN 60601-2-30:2003	Medicinska električna oprema – Dio 2-30: Posebni zahtjevi za sigurnost, uključivo i bitne zahtjeve, opreme za automatsko cikličko neinvazivno nadziranje krvnoga tlaka (IEC 60601-2-30:1999; EN 60601-2-30:2000)	EN 60601-2-30:2000	Medical electrical equipment – Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30:1999; EN 60601-2-30:2000)
HRN EN 60601-2-31:2000	Medicinski električni uređaji – Dio 2-31: Posebni zahtjevi za sigurnost vanjskih elektrostimulatora srca s vlastitim izvorom napajanja (IEC 60601-2-30:1994+am1:1998; EN 60601-2-31:1995+A1:1998)	EN 60601-2-31:1995	Medical electrical equipment – Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source (IEC 60601-2-30:1994+am1:1998; EN 60601-2-31:1995+A1:1998)
HRN EN 60601-2-3:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za kratkovalne terapijske uređaje (IEC 60601-2-3:1991; EN 60601-2-3:1993)	EN 60601-2-3:1993	Medical electrical equipment – Part 2: Particular requirements for the safety of short-wave therapy equipment (IEC 60601-2-3:1991; EN 60601-2-3:1993)
HRN EN 60601-2-3:1999/A1:2000	Medicinski električni uređaji – Dio 2-3: Posebni zahtjevi za sigurnost kratkovalnih terapijskih uređaja (IEC 60601-2-3:1991/am1:1998; EN 60601-2-3:1993/A1:1998)	EN 60601-2-3:1993/A1:1998	Medical electrical equipment – Part 2-3: Particular requirements for the safety of short-wave therapy equipment (IEC 60601-2-3:1991/am1:1998; EN 60601-2-3:1993/A1:1998)
HRN EN 60601-2-32:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za prateću opremu uređaja za X-zračenje (IEC 60601-2-32:1994; EN 60601-2-32:1994)	EN 60601-2-32:1994	Medical electrical equipment – Part 2: Particular requirements for the safety of associated equipment of X-ray equipment (IEC 60601-2-32:1994; EN 60601-2-32:1994)
HRN EN 60601-2-33:2003	Medicinska električna oprema – Dio 2-33: Posebni zahtjevi za sigurnost opreme za medicinsku dijagnostiku s pomoću magnetske rezonancije (IEC 60601-2-33:2002; EN 60601-2-33:2002)	EN 60601-2-33:2002	Medical electrical equipment – Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002; EN 60601-2-33:2002)
HRN EN 60601-2-33:2003/A1:2008	Medicinski električni uređaji – Dio 2-33: Posebni zahtjevi za sigurnost opreme za medicinsku dijagnostiku pomoću magnetske rezonancije (IEC 60601-2-33:2002/am1:2005; EN 60601-2-33:2002/A1:2005)	EN 60601-2-33:2002/A1:2005	Medical electrical equipment – Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002/am1:2005; EN 60601-2-33:2002/A1:2005)
HRN EN 60601-2-33:2003/A2:2008	Medicinski električni uređaji – Dio 2-33: Posebni zahtjevi za sigurnost opreme za medicinsku dijagnostiku pomoću magnetske rezonancije (IEC 60601-2-33:2002/am2:2007; EN 60601-2-33:2002/A2:2008+AC:2008)	EN 60601-2-33:2002/A2:2008	Medical electrical equipment – Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002/am2:2007; EN 60601-2-33:2002/A2:2008+AC:2008)
HRN EN 60601-2-34:2003	Medicinska električna oprema – Dio 2-34: Posebni zahtjevi za sigurnost, uključivo i bitne zahtjeve, opreme za invazivno nadziranje krvnoga tlaka (IEC 60601-2-34:2000; EN 60601-2-34:2000)	EN 60601-2-34:2000	Medical electrical equipment – Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment (IEC 60601-2-34:2000; EN 60601-2-34:2000)
HRN EN 60601-2-35:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za grijaće deke, jastuke i madrace u medicinskoj uporabi (IEC 60601-2-35:1996; EN 60601-2-35:1996)	EN 60601-2-35:1996	Medical electrical equipment – Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use (IEC 60601-2-35:1996; EN 60601-2-35:1996)
HRN EN 60601-2-36:2000	Medicinski električni uređaji – Dio 2-36: Posebni zahtjevi za sigurnost uređaja za izvantjelesno induciranu litotripsiju (IEC 60601-2-36:1997; EN 60601-2-36:1997)	EN 60601-2-36:1997	Medical electrical equipment – Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997; EN 60601-2-36:1997)
HRN EN 60601-2-37:2003	Medicinska električna oprema – Dio 2-37: Posebni zahtjevi za sigurnost ultrazvučne opreme za dijagnostiku i nadzor (IEC 60601-2-37:2001; EN 60601-2-37:2001)	EN 60601-2-37:2001	Medical electrical equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2001; EN 60601-2-37:2001)
HRN EN 60601-2-37:2003/A1:2008	Medicinski električni uređaji – Dio 2-37: Posebni zahtjevi za sigurnost ultrazvučne opreme za dijagnostiku i nadzor (IEC 60601-2-37:2001/am1:2004; EN 60601-2-37:2001/A1:2005)	EN 60601-2-37:2001/A1:2005	Medical electrical equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2001/am1:2004; EN 60601-2-37:2001/A1:2005)
HRN EN 60601-2-37:2003/A2:2008	Medicinski električni uređaji – Dio 2-37: Posebni zahtjevi za sigurnost ultrazvučne opreme za dijagnostiku i nadzor (IEC 60601-2-37:2001/am2:2005; EN 60601-2-37:2001/A2:2005)	EN 60601-2-37:2001/A2:2005	Medical electrical equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2001/am2:2005; EN 60601-2-37:2001/A2:2005)
HRN EN 60601-2-37:2008	Medicinski električni uređaji – Dio 2-37: Posebni zahtjevi za osnovnu sigurnost i bitne radne značajke ultrazvučne opreme za dijagnostiku i nadzor (IEC 60601-2-37:2007; EN 60601-2-37:2008)	EN 60601-2-37:2008	Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007; EN 60601-2-37:2008)
HRN EN 60601-2-38:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za električne bolničke krevete (IEC 60601-2-38:1996; EN 60601-2-38:1996)	EN 60601-2-38:1996	Medical electrical equipment – Part 2: Particular requirements for the safety of electrically operated hospital beds (IEC 60601-2-38:1996; EN 60601-2-38:1996)
HRN EN 60601-2-38:1999/A1:2003	Medicinska električna oprema – Dio 2-38: Posebni zahtjevi za sigurnost električnih bolničkih kreveta (IEC 60601-2-38:1996/am1:1999; EN 60601-2-38:1996/A1:2000)	EN 60601-2-38:1996/A1:2000	Medical electrical equipment – Part 2-38: Particular requirements for the safety of electrically operated hospital beds (IEC 60601-2-38:1996/am1:1999; EN 60601-2-38:1996/A1:2000)
HRN EN 60601-2-39:2003	Medicinska električna oprema – Dio 2-39: Posebni zahtjevi za sigurnost opreme za peritonealnu dijalizu (IEC 60601-2-39:1999; EN 60601-2-39:1999+Corr.:1999)	EN 60601-2-39:1999	Medical electrical equipment – Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment (IEC 60601-2-39:1999; EN 60601-2-39:1999+Corr.:1999)
HRN EN 60601-2-39:2008	Medicinski električni uređaji – Dio 2-39: Posebni zahtjevi za osnovnu sigurnost i bitne radne značajke uređaja za peritonealnu hemodijalizu (IEC 60601-2-39:2007; EN 60601-2-39:2008)	EN 60601-2-39:2008	Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007; EN 60601-2-39:2008)
HRN EN 60601-2-40:2000	Medicinski električni uređaji – Dio 2-40: Posebni zahtjevi za sigurnost elektromiografa i uređaja za evocirane potencijale (IEC 60601-2-40:1998; EN 60601-2-40:1998)	EN 60601-2-40:1998	Medical electrical equipment – Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998; EN 60601-2-40:1998)
HRN EN 60601-2-41:2003	Medicinska električna oprema – Dio 2-41: Posebni zahtjevi za sigurnost kirurške i dijagnostičke opreme za osvjetljavanje (IEC 60601-2-41:2000; EN 60601-2-41:2000)	EN 60601-2-41:2000	Medical electrical equipment – Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2000; EN 60601-2-41:2000)
HRN EN 60601-2-4:2003	Medicinska električna oprema – Dio 2-4: Posebni zahtjevi za sigurnost srčanih defibrilatora (IEC 60601-2-4:2002; EN 60601-2-4:2003)	EN 60601-2-4:2003	Medical electrical equipment – Part 2-4: Particular requirements for the safety of cardiac defibrilators (IEC 60601-2-4:2002; EN 60601-2-4:2003)
HRN EN 60601-2-43:2003	Medicinska električna oprema – Dio 2-43: Posebni zahtjevi za sigurnost rendgenske opreme za intervencijske zahvate (IEC 60601-2-43:2000; EN 60601-2-43:2000)	EN 60601-2-43:2000	Medical electrical equipment – Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures (IEC 60601-2-43:2000; EN 60601-2-43:2000)
HRN EN 60601-2-44:2003	Medicinska električna oprema – Dio 2-44: Posebni zahtjevi za sigurnost rendgenske opreme za kompjutoriziranu tomografiju (IEC 60601-2-44:2001+am1:2002+Corr. 1:2006; EN 60601-2-44:2001+A1:2003)	EN 60601-2-44:2001	Medical electrical equipment – Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography (IEC 60601-2-44:2001+am1:2002+Corr. 1:2006; EN 60601-2-44:2001+A1:2003)
HRN EN 60601-2-45:2003	Medicinska električna oprema – Dio 2-45: Posebni zahtjevi za sigurnost mamografske rendgenske opreme i mamografskih stereotaktičkih naprava (IEC 60601-2-45:2001; EN 60601-2-45:2001)	EN 60601-2-45:2001	Medical electrical equipment – Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2001; EN 60601-2-45:2001)
HRN EN 60601-2-46:2000	Medicinski električni uređaji – Dio 2-46: Posebni zahtjevi za sigurnost operacijskih stolova (IEC 60601-2-46:1998; EN 60601-2-46:1998)	EN 60601-2-46:1998	Medical electrical equipment – Part 2-46: Particular requirements for the safety of operating tables (IEC 60601-2-46:1998; EN 60601-2-46:1998)
HRN EN 60601-2-47:2003	Medicinska električna oprema – Dio 2-47: Posebni zahtjevi za sigurnost, uključivo i bitne zahtjeve, za ambulantne elektrokardiografske sustave (IEC 60601-2-47:2001; EN 60601-2-47:2001)	EN 60601-2-47:2001	Medical electrical equipment – Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001; EN 60601-2-47:2001)
HRN EN 60601-2-49:2003	Medicinska električna oprema – Dio 2-49: Posebni zahtjevi za sigurnost višefunkcijske opreme za nadzor pacijenata (IEC 60601-2-49:2001; EN 60601-2-49:2001)	EN 60601-2-49:2001	Medical electrical equipment – Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001; EN 60601-2-49:2001)
HRN EN 60601-2-50:2003	Medicinska električna oprema – Dio 2-50: Posebni zahtjevi za sigurnost opreme za fototerapiju novorođenčadi (IEC 60601-2-50:2000+Corr.1:2001; EN 60601-2-50:2002)	EN 60601-2-50:2002	Medical electrical equipment – Part 2-50: Particular requirements for the safety of infant phototherapy equipment (IEC 60601-2-50:2000+Corr.1:2001; EN 60601-2-50:2002)
HRN EN 60601-2-51:2003	Medicinska električna oprema – Dio 2-51: Posebni zahtjevi za sigurnost, uključivo i bitne karakteristike, jednokanalnih i višekanalnih elektrokardiografa, s mogućnošću registracije i analize signala (IEC 60601-2-51:2003; EN 60601-2-51:2003)	EN 60601-2-51:2003	Medical electrical equipment – Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2003; EN 60601-2-51:2003)
HRN EN 60601-2-5:2003	Medicinska električna oprema – Dio 2-5: Posebni zahtjevi za sigurnost ultrazvučne opreme za fizikalnu terapiju (IEC 60601-2-5:2000; EN 60601-2-5:2000)	EN 60601-2-5:2000	Medical electrical equipment – Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000; EN 60601-2-5:2000)
HRN EN 60601-2-7:2000	Medicinski električni uređaji – Dio 2-7: Posebni zahtjevi za sigurnost visokonaponskih generatora dijagnostičkih izvora rendgenskog zračenja (IEC 60601-2-7:1998; EN 60601-2-7:1998)	EN 60601-2-7:1998	Medical electrical equipment – Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators (IEC 60601-2-7:1998; EN 60601-2-7:1998)
HRN EN 60601-2-8:1999	Medicinski električni uređaji – 2. dio: Posebni sigurnosni zahtjevi za terapijske generatore X-zraka (IEC 60601-2-8:1987+am1:1997; EN 60601-2-8:1997+A1:1997)	EN 60601-2-8:1997	Medical electrical equipment – Part 2: Particular requirements for the safety of therapeutic X-ray generators (IEC 60601-2-8:1987+am1:1997; EN 60601-2-8:1997+A1:1997)
HRN EN 60627:2003	Dijagnostička rendgenska oprema – Opće značajke uporabljivosti i svojstva mamografskih rešetki protiv rasipanja zračenja (IEC 60627:2001; EN 60627:2001+Corr.:2002)	EN 60627:2001	Diagnostic X-ray imaging equipment – Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001; EN 60627:2001+Corr.:2002)
HRN EN 60645-1:2002	Elektroakustika – Mjerila sluha 1.dio: Mjerila sluha s čistim tonom (IEC 60645-1:2001; EN 60645-1:2001)	EN 60645-1:2001	Electroacoustics – Audiological equipment – Part 1: Pure-tone audiometers (IEC 60645-1:2001; EN 60645-1:2001)
HRN EN 60645-2:1998	Audiometri – 2. dio: Oprema za govornu audiometriju (IEC 60645-2:1993; EN 60645-2:1997)	EN 60645-2:1997	Audiometers – Part 2: Equipment for speech audiometry (IEC 60645-2:1993; EN 60645-2:1997)
HRN EN 60645-3:1998	Audiometri – 3. dio: Kratkotrajni slušni ispitni signali za audiometrijske i neuro-otološke namjene (IEC 60645-3:1994; EN 60645-3:1995)	EN 60645-3:1995	Audiometers – Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes (IEC 60645-3:1994; EN 60645-3:1995)
HRN EN 60645-3:2008	Elektroakustika – Audiometarska oprema – 3. dio: Kratkotrajni ispitni signali (IEC 60645-3:2007; EN 60645-3:2007)	EN 60645-3:2007	Electroacoustics – Audiometric equipment – Part 3: Test signals of short duration (IEC 60645-3:2007; EN 60645-3:2007)
HRN EN 60645-4:1998	Audiometri – 4. dio: Oprema za audiometriju u proširenom visokofrekvencijskom području (IEC 60645-4:1994; EN 60645-4:1995)	EN 60645-4:1995	Audiometers – Part 4: Equipment for extended high-frequency audiometry (IEC 60645-4:1994; EN 60645-4:1995)
HRN EN 61217:2000	Radioterapijski uređaji – Koordinate, pokretanja i skale (IEC 61217:1996; EN 61217:1996)	EN 61217:1996	Radiotherapy equipment – Coordinates, movements and scales (IEC 61217:1996; EN 61217:1996)
HRN EN 61217:2000/A1:2003	Radioterapijska oprema – Koordinate, pokretanja i skale (IEC 61217:1996/am1:2000; EN 61217:1996/A1:2001)	EN 61217:1996/A1:2001	Radiotherapy equipment – Coordinates, movements and scales (IEC 61217:1996/am1:2000; EN 61217:1996/A1:2001)
HRN EN 61217:2000/A2:2008	Radioterapijska oprema – Koordinate, pokretanja i skale (IEC 61217:1996/am2:2007; EN 61217:1996/A2:2008)	EN 61217:1996/A2:2008	Radiotherapy equipment – Coordinates, movements and scales (IEC 61217:1996/am2:2007; EN 61217:1996/A2:2008)
HRN EN 61676:2003	Medicinska električna oprema – Uređaji za neinvazivno mjerenje zračenja rendgenske cijevi u dijagnostičkoj radiologiji (IEC 61676:2002; EN 61676:2002)	EN 61676:2002	Medical electrical equipment – Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002; EN 61676:2002)
HRN EN 62083:2003	Medicinska električna oprema – Zahtjevi za sigurnost radioterapijskih (opreme) sustava za planiranje terapije (IEC 62083:2000; EN 62083:2001)	EN 62083:2001	Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2000; EN 62083:2001)
HRN EN 62220-1:2008	Medicinski električni uređaji – Značajke digitaliziranih rendgenskih uređaja – 1. dio: Određivanje osjetljivosti otkrivanja (detekcije) zračenja (IEC 62220-1:2003; EN 62220-1:2004)	EN 62220-1:2004	Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1: Determination of the detective quantum efficiency (IEC 62220-1:2003; EN 62220-1:2004)
HRN EN 62220-1-2:2008	Medicinski električni uređaji – Značajke digitaliziranih rendgenskih uređaja – Dio 1-2: Određivanje osjetljivosti otkrivanja (detekcije) zračenja – Detektori za uporabu u mamografiji (IEC 62220-1-2:2007; EN 62220-1-2:2007)	EN 62220-1-2:2007	Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-2: Determination of the detective quantum efficiency – Detectors used in mammography (IEC 62220-1-2:2007; EN 62220-1-2:2007)
HRN EN 62220-1-3:2008	Medicinski električni uređaji – Značajke digitaliziranih rendgenskih uređaja – Dio 1-3: Određivanje osjetljivosti otkrivanja (detekcije) zračenja – Detektori za uporabu pri dobivanju dinamičkih slika (IEC 62220-1-3:2008; EN 62220-1-3:2008)	EN 62220-1-3:2008	Medical electrical equipment – Characteristics of digital X-ray imaging devices – Part 1-3: Determination of the detective quantum efficiency – Detectors used in dynamic imaging (IEC 62220-1-3:2008; EN 62220-1-3:2008)
HRN EN 62304:2008	Programske podrške medicinskih uređaja – Održavanje programske podrške za vrijeme životnog vijeka (IEC 62304:2006; EN 62304:2006)	EN 62304:2006	Medical device software – Software life-cycle processes (IEC 62304:2006; EN 62304:2006)
HRN EN 62366:2008	Medicinski električni uređaji – Primjena prikladnog oblikovanja i konstrukcije medicinskih uređaja (IEC 62366:2007; EN 62366:2008)	EN 62366:2008	Medical devices – Application of usability engineering to medical devices (IEC 62366:2007; EN 62366:2008)

Klasa: 011-02/10-02/59

Urbroj: 534-07-10-3

Zagreb, 1. lipnja 2010.

Potpredsjednik Vlade

i ministar zdravstva i socijalne skrbi

mr. Darko Milinović, dr. med., v. r.

Izvor: https://narodne-novine.nn.hr/clanci/sluzbeni/2010_06_79_2270.html

Upoznajte novi Zakon.hr

Pravni izvori sada su pregledniji, povezaniji i jednostavniji za korištenje.

Novi Zakon.hr nije samo redizajn postojeće stranice. Cjelokupnu podatkovnu osnovu izgradili smo iznova kako bismo omogućili brže pronalaženje pravnih informacija, jednostavnije povezivanje izvora i razvoj novih funkcionalnosti.

Zakoni i drugi propisi sada su strukturirani po pojedinim člancima. Time smo stvorili temelje za preciznije pretraživanje, izravno povezivanje s određenim člankom, praćenje promjena te povezivanje propisa sa sudskom praksom, podzakonskim propisima, vijestima i drugim relevantnim sadržajima.

Što donosi novi Zakon.hr?

- Novi dizajn usmjeren na preglednost i produktivnost – sadržaj, alati i povezani pravni izvori organizirani su tako da vam tijekom rada budu dostupni uz što manje dodatnih koraka.

- Pretpregledni prozor (preview pane) – povezane sadržaje možete pregledavati u posebnom bočnom prozoru, bez napuštanja propisa na kojem radite i gubitka trenutačnog konteksta.

- Nova tražilica – pretražujte sve baze zajedno ili odaberite određenu vrstu sadržaja, uz jasnije organizirane i preglednije rezultate.

- Arhiva ranijih verzija zakona – pronađite tekst zakona koji je vrijedio u određenom razdoblju, što je osobito važno za postupke koji se odnose na ranije nastale pravne odnose.

- Usporedba verzija – usporedite različite verzije zakona i lakše utvrdite što je pojedinom izmjenom promijenjeno.

- Povezani pravni izvori – sa stranice pojedinog zakona brzo pristupite podzakonskim propisima, povezanim zakonima, ranijim verzijama i pripadajućim vijestima.

- Praćenje sadržaja i obavijesti – pratite odabrane pravne sadržaje i primajte obavijesti o njihovim promjenama.

- Preuzimanje dokumenata – ovisno o odabranom paketu, dokumente možete preuzimati u PDF ili Word formatu.

Besplatna registracija

Otvorite korisnički račun i upoznajte mogućnosti novog sustava. Registracija je besplatna i sama po sebi ne stvara obvezu plaćanja.

Registrirani korisnici mogu upravljati svojim profilom, praćenim sadržajima, obavijestima i drugim dostupnim postavkama.

Novi paketi pretplate

Za pristup naplatnim bazama i naprednim funkcionalnostima dostupni su novi paketi pretplate Classic i PLUS.

Odaberite paket prema opsegu sadržaja i funkcija koje su vam potrebne. Paket PLUS namijenjen je korisnicima koji Zakon.hr redovito koriste kao profesionalni radni alat i žele puni pristup dostupnim pravnim sadržajima i funkcionalnostima.

Zakon.hr je trenutačno u beta fazi

Novu verziju nastavljamo razvijati. Još uvijek dopunjavamo i provjeravamo baze podataka, povezujemo postojeće sadržaje te postupno uvodimo nove funkcionalnosti.

Ako primijetite pogrešku, nedostatak ili imate prijedlog za poboljšanje, javite nam se. Vaše iskustvo pomoći će nam da Zakon.hr učinimo još pouzdanijim i praktičnijim pravnim alatom.