## Popis hrvatskih normi za medicinske proizvode 2010-05-24

### NN 79/2010 (24.6.2010.), Popis hrvatskih normi za medicinske proizvode 2010-05-24

MINISTARSTVO ZDRAVSTVA I SOCIJALNE SKRBI

2270

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.

Ostalo, NN 79/2010-2270