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Seznam standardov katerih uporaba ustvarja domnevo o skladnosti s pravilnikom o medicinskih pripomočkih, stran 9925.

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  1. člena pravilnika o medicinskih pripomočkih (Uradni list RS, št. 82/00) minister za zdravstvo v soglasju z ministrom za ekonomske odnose in razvoj objavlja S E Z N A M S T A N D A R D O V katerih uporaba ustvarja domnevo o skladnosti s pravilnikom o medicinskih pripomočkih Oznaka standarda1 Naslov standarda v slovenskem jeziku2 Naslov standarda v angleškem jeziku3 Referenčni dokument4 SIST EN 285:2000 Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji Sterilization - Steam sterilizers - Large sterilizers EN 285:1996 SIST EN 455-1:2000 Medicinske rokavice za enkratno uporabo -
  2. del: Zahteve in preskusi za ugotavljanje luknjičavosti Medical gloves for single use - Part 1: Requirements and testing for freedom from holes EN 455-1:1993 SIST EN 455-2:2000 Medicinske rokavice za enkratno uporabo -
  3. del: Zahteve in preskusi za ugotavljanje fizikalnih lastnosti Medical gloves for single use - Part 2: Requirements and testing for physical properties EN 455-2:1995 SIST EN 540:2000 Klinične raziskave medicinskih pripomočkov za ljudi Clinical investigation of medical devices for human subjects EN 540:1993 SIST EN 550:2000 Sterilizacija medicinskih pripomočkov - Validacija in redni nadzor sterilizacije z etilenoksidom Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization EN 550:1994 SIST EN 552:2000 Sterilizacija medicinskih pripomočkov - Validacija in redni nadzor sterilizacije z obsevanjem Sterilization of medical devices - Validation and routine control of sterilization by irradiation EN 552:1994 SIST EN 552:2000/A1:2000 Sterilizacija medicinskih pripomočkov - Validacija in redni nadzor sterilizacije z obsevanjem Sterilization of medical devices - Validation and routine control of sterilization by irradiation EN 552:1994/A1:1999 SIST EN 554:2000 Sterilizacija medicinskih pripomočkov - Validacija in redni nadzor sterilizacije z vlažno toploto Sterilization of medical devices - Validation and routine control of sterilization by moist heat EN 554:1994 SIST EN 556:1999 Sterilizacija medicinskih pripomočkov – Zahteve ze medicinske pripomočke, ki morajo biti označeni kot »sterilni« Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile" EN 556:1994 SIST EN 600:2000 Moški kondomi iz naravnega kavčuka Natural rubber latex male condoms EN 600:1996 SIST EN 724:2000 Navodilo za uporabo EN 29001 in EN 46001 ter EN 29002 in EN 46002 za ne-aktivne medicinske pripomočke Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices EN 724:1994 SIST EN 737-1:2000 Sistemi napeljav za medicinske pline -
  4. del: Končni deli za stisnjene medicinske pline in podtlak Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum EN 737-1:1998 SIST EN 737-2:2000 Sistemi napeljav za medicinske pline -
  5. del: Sistemi za odstranjevanje anestezijskih plinov in hlapov - Osnovne zahteve Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements EN 737-2:1998 SIST EN 737-3:2000 Sistemi napeljav za medicinske pline -
  6. del: Napeljave za stisnjene medicinske pline in podtlak Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum EN 737-3:1998 SIST EN 737-4:2000 Sistemi napeljav za medicinske pline -
  7. del: Končni deli sistemov za odstranjevanje anestezijskih plinov in hlapov Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems EN 737-4:1998 SIST EN 738-1:2000 Tlačni regulatorji za medicinske pline -
  8. del: Tlačni regulatorji in tlačni regulatorji s pretočnimi merilniki Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices EN 738-1:1997 SIST EN 739:2000 Nizkotlačne povezovalne cevi za delo z medicinskimi plini Low-pressure hose assemblies for use with medical gases EN 739:1998 SIST EN 740:2000 Delovna mesta za anesteziranje in njihova oprema - Posebne zahteve Anaesthetic workstations and their modules - Particular requirements EN 740:1998 SIST EN 793:2000 Posebne zahteve za varnost medicinskih preskrbovalnih enot Particular requirements for safety of medical supply units EN 793:1997 SIST EN 794-1:2000 Pljučni ventilatorji -
  9. del: Posebne zahteve za ventilatorje za intenzivno nego Lung ventilators - Part 1: Particular requirements for critical care ventilators EN 794-1:1997 SIST EN 794-2:2000 Pljučni ventilatorji -
  10. del: Posebne zahteve za uporabo na domu Lung ventilators - Part 2: Particular requirements for home care use EN 794-2:1997 SIST EN 794-3:2000 Pljučni ventilatorji -
  11. del: Posebne zahteve za ventilatorje za nujno medicinsko pomoč in prevoz Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators EN 794-3:1998 SIST EN 864:2000 Elektromedicinska oprema - Merilniki CO2 (kapnometri) za uporabo pri ljudeh - Posebne zahteve Medical electrical equipment - Capnometers for use with humans - Particular requirements EN 864:1996 SIST EN 865:2000 Pulzni oksimetri - Posebne zahteve Pulse oximeters - Particular requirements EN 865:1997 SIST EN 867-2:2000 Nebiološki sistemi za uporabo v sterilizatorjih -
  12. del: Indikatorji postopkov (razred A) Non-biological systems for use in sterilizers - Part 2: Process indicators (Class A) EN 867-2:1997 SIST EN 867-3:2000 Nebiološki sistemi za uporabo v sterilizatorjih -
  13. del: Specifikacija za indikatorje razreda B za uporabo v Bowie-Dickovem preskusu Non-biological systems for use in sterilizers - Part 3: Specification for Class B indicators for use in the Bowie and Dick test EN 867-3:1997 SIST EN 868-1:2000 Embalažni materiali in sistemi za medicinske pripomočke, ki jih je treba sterilizirati -
  14. del: Splošne zahteve in preskusne metode Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods EN 868-1:1997 SIST EN 1041:2000 Informacije, ki jih proizvajalec priloži medicinskim pripomočkom Information supplied by the manufacturer with medical devices EN 1041:1998 SIST EN 1060-1:2000 Neinvazivni sfigmomanometri -
  15. del: Splošne zahteve Non-invasive sphygmomanometers - Part 1: General requirements EN 1060-1:1995 SIST EN 1060-2:2000 Neinvazivni sfigmomanometri -
  16. del: Dodatne zahteve za mehanske sfigmomanometre Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers EN 1060-2:1995 SIST EN 1060-3:2000 Neinvazivni sfigmomanometri -
  17. del: Dodatne zahteve za elektromehanske sisteme za merjenje krvnega tlaka Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems EN 1060-3:1997 SIST EN 1089-3:1999 Plinske jeklenke - Označevanje jeklenk (razen UNP) -
  18. del: Barvno označevanje Transportable gas cylinders - Cylinder identification - Part 3: Colour coding EN 1089-3:1997 SIST EN 1174-1:2000 Sterilizacija medicinskih pripomočkov - Ocena populacije mikroorganizmov na izdelku -
  19. del: Zahteve Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements EN 1174-1:1996 SIST EN 1174-2:2000 Sterilizacija medicinskih pripomočkov - Ocena populacije mikroorganizmov na izdelku -
  20. del: Navodilo Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance EN 1174-2:1996 SIST EN 1174-3:2000 Sterilizacija medicinskih pripomočkov - Ocena populacije mikroorganizmov na izdelku -
  21. del: Vodilo za validacijske metode mikrobioloških postopkov Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques EN 1174-3:1996 SIST EN 1280-1:2000 Sistemi za nalivanje specifičnih hlapnih anestetikov v anestezijske hlapilnike (vaporizatorje) -
  22. del: Sistemi s pravokotnimi vtikači Agent specific filling systems for anaesthetic vaporizers - Part 1: Rectangular keyed filling systems EN 1280-1:1997 SIST EN 1281-1:2000 Anestezijska in dihalna oprema - Stožčasti priključki -
  23. del: Vtikači in vtičnice Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets EN 1281-1:1997 SIST EN 1281-1:2000/A1:2000 Anestezijska in dihalna oprema - Stožčasti priključki -
  24. del: Vtikači in vtičnice Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets EN 1281-1:1997/A1:1998 SIST EN 1281-2:2000 Anestezijska in dihalna oprema - Stožčasti priključki -
  25. del: Nosilni priključki z navojem (ISO 5356-2:1987, spremenjen) Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified) EN 1281-2:1995 SIST EN 1282-1:2000 Anestezijska in dihalna oprema - Traheostomske cevke -
  26. del: Cevke, ki se uporabljajo pri odraslih Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes for use in adults EN 1282-1:1996 SIST EN 1282-2:2000 Traheostomske cevke -
  27. del: Cevke, ki se uporabljajo pri otrocih Tracheostomy tubes - Part 2: Pediatric tubes EN 1282-2:1997 SIST EN 1422:2000 Sterilizatorji za uporabo v medicini - Sterilizatorji z etilenoksidom - Zahteve in preskusne metode Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods EN 1422:1997 SIST EN 1441:2000 Medicinski pripomočki – Analiza tveganja Medical devices - Risk analysis EN 1441:1997 SIST EN 1618:2000 Katetri, razen žilnih (intravaskularnih) katetrov - Preskusne metode za ugotavljanje splošnih lastnosti Catheters other than intravascular catheters - Test methods for common properties EN 1618:1997 SIST EN 1639:2000 Zobozdravstvo – Medicinski pripomočki v zobozdravstvu – Inštrumenti Dentistry - Medical devices for dentistry - Instruments EN 1639:1996 SIST EN 1640:2000 Zobozdravstvo – Medicinski pripomočki v zobozdravstvu - Oprema Dentistry - Medical devices for dentistry - Equipment EN 1640:1996 SIST EN 1641:2000 Zobozdravstvo – Medicinski pripomočki v zobozdravstvu – Materiali Dentistry - Medical devices for dentistry - Materials EN 1641:1996 SIST EN 1642:2000 Zobozdravstvo – Medicinski pripomočki v zobozdravstvu – Zobni vsadki (implantati) Dentistry - Medical devices for dentistry - Dental implants EN 1642:1996 SIST EN 1707:2000 Stožčaste spojke s 6-odstotnim (Luerjevim) nastavkom za injekcijske brizge, igle in nekatero drugo medicinsko opremo - Spojke Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings EN 1707:1996 SIST EN 1782:2000 Sapnični (endotrahealni) tubusi in priključki Tracheal tubes and connectors EN 1782:1998 SIST EN 1819:2000 Laringoskopi za trahealno intubacijo - Posebne zahteve Laryngoscopes for tracheal intubation - Particular requirements EN 1819:1997 SIST EN 1820:2000 Dihalni baloni Anaesthetic reservoir bags EN 1820:1997 SIST EN 1985:2000 Pripomočki za hojo - Splošne zahteve in preskusne metode Walking aids - General requirements and test methods EN 1985:1998 SIST EN 12006-2:2000 Neaktivni kirurški vsadki (implantati)- Posebne zahteve za srčnožilne vsadke (kardiovaskularne implantate) -
  28. del: Žilne proteze, vključno s cevastimi vsadki s srčnimi zaklopkami (tubularnimi grafti) Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits EN 12006-2:1998 SIST EN 12006-3:2000 Neaktivni kirurški vsadki (implantati)- Posebne zahteve za srčnožilne vsadke (kardiovaskularni implantati) -
  29. del: Znotrajžilni pripomočki Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices EN 12006-3:1998 SIST EN 12010:2000 Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve Non-active surgical implants - Joint replacement implants - Particular requirements EN 12010:1998 SIST EN 12011:2000 Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) - Splošne zahteve Instrumentation to be used in association with non-active surgical implants - General requirements EN 12011:1998 SIST EN 12183:2000 Invalidski vozički na ročni pogon - Zahteve in preskusne metode Manually propelled wheelchairs - Requirements and test methods EN 12183:1999 SIST EN 12184:2000 Električni invalidski vozički, skuterji in njihovo polnjenje - Zahteve in preskusne metode Electrically powered wheelchairs, scooters and their charges - Requirements and test methods EN 12184:1999 SIST EN 12342:2000 Dihalne cevke za uporabo z anestezijskimi aparati in ventilatorji Breathing tubes intended for use with anaesthetic apparatus and ventilators EN 12342:1998 SIST EN 12523:2000 Zunanje proteze za ude in zunanje ortoze - Zahteve in preskusne metode External limb prostheses and external orthoses - Requirements and test methods EN 12523:1999 SIST EN 12563:2000 Neaktivni kirurški vsadki (implantati) - Sklepne proteze - Posebne zahteve za umetni kolk Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants EN 12563:1998 SIST EN 12564:2000 Neaktivni kirurški vsadki (implantati) - Kolenske proteze - Posebne zahteve za kolensko protezo Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants EN 12564:1998 SIST EN 12598:2000 Monitorji za kisik pri vdihavanju dihalne zmesi - Posebne zahteve Oxygen monitors for patient breathing mixtures - Particular requirements EN 12598:1999 SIST EN 20594-1:2000 Stožčaste spojke s 6-odstotnim (Luerjevim) nastavkom za injekcijske brizge, igle in nekatero drugo medicinsko opremo -
  30. del: Splošne zahteve (ISO 594-1:1986) 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 SIST EN 20594-1:2000/A1:2000 Stožčaste spojke s 6-odstotnim (Luerjevim) nastavkom za injekcijske brizge, igle in nekatero drugo medicinsko opremo -
  31. del: Splošne zahteve (ISO 594-1:1986) 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 SIST EN ISO 4135:2000 Anesteziologija - Slovar (ISO 4135:1995) Anaesthesiology - Vocabulary (ISO 4135:1995) EN ISO 4135:1996 SIST EN 27740:2000 Kirurški instrumenti, skalpeli s snemnimi rezili, mere nastavkov (ISO 7740:1985) Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) EN 27740:1992 SIST EN 27740:2000/A1:2000 Kirurški instrumenti, skalpeli s snemnimi rezili, mere nastavkov (ISO 7740:1985) Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) EN 27740:1992/A1:1997 SIST EN ISO 8185:2000 Vlažilniki za uporabo v medicini - Splošne zahteve za vlažilne sisteme (ISO 8185:1997) Humidifiers for medical use - General requirements for humidification systems (ISO 8185:1997) EN ISO 8185:1997 SIST EN ISO 8359:2000 Naprave za koncentriranje kisika za uporabo v medicini - Varnostne zahteve (ISO 8359:1996) Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996) EN ISO 8359:1996 SIST EN ISO 9703-3:2000 Alarmne naprave pri anasteziji in oskrbi – zdravljenju dihal -
  32. del: Navodilo za uporabo alarmnih naprav (ISO 9703-3:1998) Anaesthesia and respiratory care alarm signals - Part 3: Guidance on application of alarms (ISO 9703-3:1998) EN ISO 9703-3:1998 SIST EN ISO 10079-1:1999 Medicinska sukcijska (aspiracijska) oprema -
  33. del: Električna sukcijska (aspiracijska) oprema - Varnostne zahteve (ISO 10079-1:1991, vključno s tehničnima popravkoma 1:1992 in 2:1993) Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1991, including Technical Corrigendum 1:1992 and Technical Corrigendum 2:1993) EN ISO 10079-1:1996 SIST EN ISO 10079-2:1999 Medicinska sukcijska (aspiracijska) oprema -
  34. del: Ročna sukcijska (aspiracijska) oprema (ISO 10079-2:1992) Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1992) EN ISO 10079-2:1996 SIST EN ISO 10079-3:1999 Medicinska sukcijska (aspiracijska) oprema -
  35. del: Podtlačna ali tlačna sukcijska (aspiracijska) oprema (ISO 10079-3:1992) Medical suction equipment - Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1992) EN ISO 10079-3:1996 SIST EN ISO 10555-1:2000 Sterilni žilni katetri za enkratno uporabo -
  36. del: Splošne zahteve (ISO 10555-1:1995) Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995) EN ISO 10555-1:1996 SIST EN ISO 10993-1:2000 Biološko ovrednotenje medicinskih pripomočkov -
  37. del: Ocena in preskusi (ISO 10993-1:1997) Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997) EN ISO 10993-1:1997 SIST EN 30993-3:2000 Biološko ovrednotenje medicinskih pripomočkov -
  38. del: Preskusi genske toksičnosti, kancerogenosti in toksičnosti za razmnoževanje (ISO 10993-3:1992) Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992) EN 30993-3:1993 SIST EN 30993-4:2000 Biološko ovrednotenje medicinskih pripomočkov -
  39. del: Izbira preskusov za ugotavljanje interakcij s krvjo (ISO 10993-4:1992) Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:1992) EN 30993-4:1993 SIST EN 30993-5:1999 Biološko ovrednotenje medicinskih pripomočkov -
  40. del: Preskusi citotoksičnosti – metode in vitro (ISO 10993-5:1992) Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - in vitro methods (ISO 10993-5:1992) EN 30993-5:1993 SIST EN ISO 10993-5:2000 Biološko ovrednotenje medicinskih pripomočkov -
  41. del: Preskusi za ugotavljanje citotoksičnosti in vitro (ISO 10993-5:1999) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) EN ISO 10993-5:1999 SIST EN 30993-6:2000 Biološko ovrednotenje medicinskih pripomočkov -
  42. del: Preskusi, povezani z lokalnimi učinki po implantaciji (ISO 10993-6:1994) Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994) EN 30993-6:1994 SIST EN ISO 10993-9:2000 Biološko ovrednotenje medicinskih pripomočkov -
  43. del: Okvirni sistem za prepoznavanje in ugotavljanje količine morebitnih razgradnih produktov (ISO 10993-9:1999) Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) EN ISO 10993-9:1999 SIST EN ISO 10993-10:2000 Biološko ovrednotenje medicinskih pripomočkov -
  44. del: Preskusi draženja in občutljivosti (senzibilizacije) (ISO 10993-10:1995) Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization (ISO 10993-10:1995) EN ISO 10993-10:1995 SIST EN ISO 10993-11:2000 Biološko ovrednotenje medicinskih pripomočkov -
  45. del: Preskusi sistemske toksičnosti (ISO 10993-11:1993) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:1993) EN ISO 10993-11:1995 SIST EN ISO 10993-12:2000 Biološko ovrednotenje medicinskih pripomočkov -
  46. del: Priprava vzorcev in referenčni materiali (ISO 10993-12:1996) Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:1996) EN ISO 10993-12:1996 SIST EN ISO 10993-13:2000 Biološko ovrednotenje medicinskih pripomočkov -
  47. del: Prepoznavanje in ugotavljanje količine razgradnih produktov polimerov, iz katerih so izdelani medicinski pripomočki (ISO 10993-13:1998) Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) EN ISO 10993-13:1998 SIST EN ISO 10993-16:2000 Biološko ovrednotenje medicinskih pripomočkov -
  48. del: Načrt toksikokinetičnih raziskav razgradnih produktov in izlužnin (ISO 10993-16:1997) Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) EN ISO 10993-16:1997 SIST EN ISO 11196:2000 Monitorji za spremljanje anestezijskih plinov in hlapov (ISO 11196:1995, vključno s tehničnim popravkom 1:1997) Anaesthetic gas monitors (ISO 11196:1995 including Technical Corrigendum 1:1997) EN ISO 11196:1997 SIST EN ISO 12870:2000 Očesna optika - Okviri očal - Splošne zahteve in preskusne metode (ISO 12870:1997) Ophthalmic optics - Spectacle frames - General requirements and test methods (ISO 12870:1997) EN ISO 12870:1997 SIST EN ISO 14160:2000 Sterilizacija medicinskih pripomočkov za enkratno uporabo, ki vsebujejo materiale živalskega izvora - Validacija in redni nadzor sterilizacije s tekočimi kemijskimi sredstvi za sterilizacijo (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 SIST EN ISO 14534:2000 Očesna optika - Kontaktne leče in Izdelki za vzdrževanje kontaktnih leč - Temeljne zahteve (ISO 14534:1997) Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:1997) EN ISO 14534:1997 SIST EN ISO 14602:2000 Neaktivni kirurški vsadki (implantati)- Vsadki za osteosintezo - Posebne zahteve (ISO 14602:1998) Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998) EN ISO 14602:1998 SIST EN ISO 14630:2000 Neaktivni kirurški vsadki (implantati)- Splošne zahteve (ISO 14630:1997) Non-active surgical implants - General requirements (ISO 14630:1997) EN ISO 14630:1997 SIST EN ISO 14889:2000 Očesna optika - Stekla očal - Temeljne zahteve za nebrušena gotova stekla (ISO 14889:1997) Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:1997) EN ISO 14889:1997 SIST EN ISO 15004:2000 Oftalmični instrumenti - Temeljne zahteve in preskusne metode (ISO 15004:1997) Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997) EN ISO 15004:1997 SIST EN 46001:1999 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 EN 46001:1996 SIST EN 46002:1999 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 EN 46002:1996 SIST EN 50103:1998 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry EN 50103:1995 SIST EN 60601-1:1995 Medical electrical equipment -- Part 1: General requirements for safety EN 60601-1:1990 SIST EN 60601-1:1995 Amendment to clauses 2, 3, 6, 7, 10, 14, 16, 19-22, 29, 37, 41, 44, 45, 52, 56, 57, 59 and annexes A, C, K, L of EN EN 60601-1:1990/A1:1993 SIST EN 60601-1:1995/A2:1998 Medical electrical equipment -- Part 1: General requirements for safety EN 60601-1:1990/A2:1995 SIST EN 60601-1:1995/A13:1998 Amendment to subclause 6.6 of EN EN 60601-1:1990/A13:1996 SIST EN 60601-1-1:1995 Medical electrical equipment -- Part 1: General requirements for safety --
  49. Collateral standard: Safety requirements for medical electrical systems EN 60601-1-1:1993 SIST EN 60601-1-1:1995/A1:1998 Medical electrical equipment -- Part 1: General requirements for safety --
  50. Collateral standard: Safety requirements for medical electrical systems EN 60601-1-1:1993/A1:1996 SIST EN 60601-1-2:1995 Medical electrical equipment -- Part 1: General requirements for safety --
  51. Collateral standard: Electromagnetic compatibility - Requirements and tests EN 60601-1-2:1993 SIST EN 60601-1-3:1998 Medical electrical equipment -- Part 1: General requirements for safety --
  52. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment EN 60601-1-3:1994 SIST EN 60601-1-4:1998 Medical electrical equipment -- Part 1: General requirements for safety --
  53. Collateral standard: Programmable electrical medical systems EN 60601-1-4:1996 SIST EN 60601-2-2:1995 Medical electrical equipment -- Part 2: Particular requirements for the safety of high frequency surgical equipment EN 60601-2-2:1993 SIST EN 60601-2-3:1995 Medical electrical equipment -- Part 2: Particular requirements for the safety of short-wave therapy equipment EN 60601-2-3:1993 SIST 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 EN 60601-2-7:1998 SIST EN 60601-2-8:1998/A1:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of therapeutic X-ray generators EN 60601-2-8:1997/A1:1997 SIST EN 60601-2-9:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors EN 60601-2-9:1996 SIST EN 60601-2-11:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of gamma beam therapy equipment EN 60601-2-11:1997 SIST EN 60601-2-16:1998 Medical electrical equipment -- Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment EN 60601-2-16:1998 SIST EN 60601-2-17:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment EN 60601-2-17:1996 SIST EN 60601-2-17:1998/A1:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray afterloading equipment EN 60601-2-17:1996/A1:1996 SIST EN 60601-2-18:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of endoscopic equipment EN 60601-2-18:1996 SIST EN 60601-2-19:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of baby incubators EN 60601-2-19:1996 SIST EN 60601-2-19:1995/A1:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of baby incubators EN 60601-2-19:1996/A1:1996 SIST EN 60601-2-20:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of transport incubators EN 60601-2-20:1996 SIST EN 60601-2-21:1995 Medical electrical equipment -- Part 2: Particular requirements for the safety of infant radiant warmers EN 60601-2-21:1994 SIST EN 60601-2-21:1995/A1:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of infant radiant warmers EN 60601-2-21:1994/A1:1996 SIST EN 60601-2-22:2000 Medical electrical equipment -- Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment EN 60601-2-22:1996 SIST EN 60601-2-23:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of transcutaneous partial pressure monitoring equipment EN 60601-2-23:1997 SIST EN 60601-2-24:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of infusion pumps and controllers EN 60601-2-24:1998 SIST EN 60601-2-25:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of electrocardiographs EN 60601-2-25:1995 SIST EN 60601-2-26:1995 Medical electrical equipment -- Part 2: Particular requirements for the safety of electroencephalographs EN 60601-2-26:1994 SIST EN 60601-2-27:1995 Medical electrical equipment -- Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment EN 60601-2-27:1994 SIST EN 60601-2-28:1995 Medical electrical equipment -- Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis EN 60601-2-28:1993 SIST EN 60601-2-29:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of radiotherapy simulators EN 60601-2-29:1995 SIST EN 60601-2-29:1998/A1:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of radiotherapy simulators EN 60601-2-29:1995/A1:1996 SIST EN 60601-2-30:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment EN 60601-2-30:1995 SIST EN 60601-2-31:1995 Medical electrical equipment -- Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source EN 60601-2-31:1995 SIST EN 60601-2-32:1995 Medical electrical equipment -- Part 2: Particular requirements for the safety of associated equipment of X-ray equipment EN 60601-2-32:1994 SIST EN 60601-2-33:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis EN 60601-2-33:1995 SIST EN 60601-2-34:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of direct blood pressure monitoring equipment EN 60601-2-34:1995 SIST EN 60601-2-35:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use EN 60601-2-35:1996 SIST EN 60601-2-36:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy EN 60601-2-36:1997 SIST EN 60601-2-38:1998 Medical electrical equipment -- Part 2: Particular requirements for the safety of electrically operated hospital beds EN 60601-2-38:1996 SIST EN 60601-2-40:1998 Medical electrical equipment -- Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment EN 60601-2-40:1998 SIST EN 60645-1:1999 Audiometers -- Part 1: Pure-tone audiometers EN 60645-1:1994 SIST EN 60645-2:2000 Audiometers -- Part 2: Equipment for speech audiometry EN 60645-2:1997 SIST EN 60645-3:1999 Audiometers -- Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes EN 60645-3:1995 SIST EN 60645-4:1999 Audiometers -- Part 4: Equipment for extended high-frequency audiometry EN 60645-4:1995 SIST EN ISO 10993-9:2000 Biološko ovrednotenje medicinskih pripomočkov -
  54. del: Okvirni sistem za prepoznavanje in ugotavljanje količine morebitnih razgradnih produktov (ISO 10993-9:1999) Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) EN ISO 10993-9:1999 SIST EN ISO 10993-10:2000 Biološko ovrednotenje medicinskih pripomočkov -
  55. del: Preskusi draženja in občutljivosti (senzibilizacije) (ISO 10993-10:1995) Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization (ISO 10993-10:1995) EN ISO 10993-10:1995 SIST EN ISO 10993-11:2000 Biološko ovrednotenje medicinskih pripomočkov -
  56. del: Preskusi sistemske toksičnosti (ISO 10993-11:1993) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:1993) EN ISO 10993-11:1995 SIST EN ISO 10993-12:2000 Biološko ovrednotenje medicinskih pripomočkov -
  57. del: Priprava vzorcev in referenčni materiali (ISO 10993-12:1996) Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:1996) EN ISO 10993-12:1996 SIST EN ISO 10993-16:2000 Biološko ovrednotenje medicinskih pripomočkov -
  58. del: Načrt toksikokinetičnih raziskav razgradnih produktov in izlužnin (ISO 10993-16:1997) Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) EN ISO 10993-16:1997 SIST EN 45502-1:2000 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer EN 45502-1:1997 1: Oznaka standarda: standardizirana referenčna oznaka standarda je sestavljena iz oznake za slovenski standard (SIST), številke oziroma oznake privzetega standarda in letnice izdaje. 2: Naslov standarda v slovenskem jeziku. Manjkajoči naslovi bodo objavljeni naknadno. 3: Naslov standarda v angleškem jeziku. 4: Referenčni dokument: dokument, ki je bil osnova za SIST. Št. 512/-99/00 Ljubljana, dne
  59. avgusta
  60. spec. akad. st. Andrej Bručan, dr. med. l. r. Minister za zdravstvo Soglašam! dr. Marjan Senjur l. r. Minister za ekonomske odnose in razvoj Kazalo Na vrh

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