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Seznam standardov katerih uporaba ustvarja domnevo o skladnosti s pravilnikom o medicinskih pripomočkih
DRUG708
# Seznam standardov katerih uporaba ustvarja domnevo o skladnosti s pravilnikom o medicinskih pripomočkih
Na podlagi 5. 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 - 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
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.