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 - 1. 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 - 2. 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 - 1. 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 - 2. 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 - 3. 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 - 4. 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 - 1. 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 - 1. 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 - 2. 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 - 3. 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 - 2. 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 - 3. 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 - 1. 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 - 1. del: Splošne zahteve

Non-invasive sphygmomanometers - Part 1: General requirements

EN 1060-1:1995

SIST EN 1060-2:2000

Neinvazivni sfigmomanometri - 2. 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 - 3. 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) - 3. 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 - 1. 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 - 2. 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 - 3. 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) - 1. 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 - 1. 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 - 1. 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 - 2. 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 - 1. 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 - 2. 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) - 2. 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) - 3. 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 - 1. 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 - 1. 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 - 3. 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 - 1. 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 - 2. 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 - 3. 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 - 1. 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 - 1. 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 - 3. 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 - 4. 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 - 5. 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 - 5. 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 - 6. 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 - 9. 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 - 10. 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 - 11. 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 - 12. 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 - 13. 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 - 16. 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 -- 1. 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 -- 1. 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 -- 2. 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 -- 3. 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 -- 4. 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 - 9. 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 - 10. 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 - 11. 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 - 12. 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 - 16. 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