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Format Name Language Status
Electronic Paper 

EVS-EN 1041:2008

Tootja antav info meditsiiniseadmete kohta

Information supplied by the manufacturer with medical devices

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English 
Withdrawn
from
14.11.2013
12.51 EUR
Electronic Paper 

EVS-EN 45502-1:2000

Aktiivsed implanteeritavad meditsiiniseadmed. Osa 1: Üldised ohutusnõuded, tootja antav märgistus ja informatsioon

Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer

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Estonian 
English 
Withdrawn
from
08.06.2015
17.08 EUR
Electronic Paper 

EVS-EN 45502-2-1:2004

Aktiivsed implanteeritavad meditsiiniseadmed. Osa 2-1: Erinõuded bradüarütmia (südame rütmihäirete) raviks mõeldud aktiivsetele siirdatavatele meditsiiniseadmetele (südamestimulaatorid)

Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)

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English 
Valid
from
09.09.2004
22.15 EUR
Electronic Paper 

EVS-EN 45502-2-2:2008

Aktiivsed implanteeritavad meditsiiniseadmed. Osa 2-2: Erinõuded tahhüarütmia raviks mõeldud aktiivsetele siirdatavatele meditsiiniseadmetele (sealhulgas siirdatavatele defibrillaatoritele)

Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

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English 
Valid
from
08.05.2008
23.62 EUR
Electronic Paper 

EVS-EN 45502-2-2:2008/AC:2009

Aktiivsed implanteeritavad meditsiiniseadmed. Osa 2-2: Erinõuded tahhüarütmia raviks mõeldud aktiivsetele siirdatavatele meditsiiniseadmetele (sealhulgas siirdatavatele defibrillaatoritele)

Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

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English
Valid
from
04.06.2009
0.00 EUR
Electronic Paper 

EVS-EN 45502-2-3:2010

Aktiivsed implanteeritavad meditsiiniseadmed. Osa 2-3: Erinõuded sisekõrva ja ajutüve kuuldeimplantaatidele

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

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English 
Valid
from
06.04.2010
16.10 EUR
Electronic Paper 

EVS-EN 556-1:2002

Meditsiiniseadmete steriliseerimine. Nõuded meditsiiniseadmetele, mis on märgistatud sõnaga "STERIILNE". Osa 1: Nõuded lõplikult steriliseeritud meditsiiniseadmetele

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices.

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English 
Valid
from
06.05.2002
6.47 EUR
Electronic Paper 

EVS-EN 556-2:2015

Meditsiiniseadmete steriliseerimine. Nõuded meditsiiniseadmetele vastavuseks märgistusele "Steriilne". Osa 2: Nõuded aseptiliselt töödeldud meditsiiniseadmetele

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

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English 
Valid
from
06.10.2015
9.49 EUR
Electronic 

EVS-EN 60601-1:2006

Elektrilised meditsiiniseadmed. Osa 1: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)

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Estonian 
English 
Valid
from
08.12.2006
39.30 EUR
Electronic Paper 

EVS-EN 60601-1:2006/A1:2013

Elektrilised meditsiiniseadmed. Osa 1: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

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English
Valid
from
14.11.2013
25.03 EUR
Electronic Paper 

EVS-EN 60601-1:2006/A1:2013+A12:2014

Elektrilised meditsiiniseadmed. Osa 1: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

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Estonian
English
Valid
from
02.03.2016
25.03 EUR
Electronic Paper 

EVS-EN 60601-1:2006/AC:2010

Elektrilised meditsiiniseadmed. Osa 1: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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Estonian
English
Valid
from
08.04.2010
0.00 EUR
Electronic 

EVS-EN 60601-1:2006+A1:2013+A12:2014

Elektrilised meditsiiniseadmed. Osa 1: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

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Estonian 
English 
Valid
from
02.03.2016
40.99 EUR
Electronic 

EVS-EN 60601-1:2006+A11:2011+A1:2013

Elektrilised meditsiiniseadmed. Osa 1: Üldised nõuded esmasele ohutusele ja olulistele toimimisnäitajatele

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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English 
Withdrawn
from
02.03.2016
39.30 EUR
Electronic Paper 

EVS-EN 60601-1-6:2010

Elektrilised meditsiiniseadmed. Osa 1-6: Üldnõuded esmasele ohutusele ja olulistele toimimisnäitajatele. Kollateraalstandard: Kasutussobivus

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

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English 
Valid
from
07.06.2010
12.51 EUR
Electronic Paper 

EVS-EN 62304:2006

Meditsiiniseadmete tarkvara. Tarkvara elutsükli protsessid

Medical device software - Software life-cycle processes

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English 
Valid
from
06.10.2006
22.15 EUR
Electronic Paper 

EVS-EN 62304:2006/AC:2008

Meditsiiniseadmete tarkvara. Tarkvara elutsükli protsessid

Medical device software - Software life-cycle processes

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English
Valid
from
03.04.2009
0.00 EUR
Electronic Paper 

EVS-EN ISO 10993-1:2009/AC:2010

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Technical Corrigendum 1

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English
Valid
from
06.09.2010
0.00 EUR
Electronic Paper 

EVS-EN ISO 10993-1:2011

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

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English 
Valid
from
03.02.2011
13.22 EUR
Electronic Paper 

EVS-EN ISO 10993-11:2009

Meditsiiniseadmete bioloogiline hindamine. Osa 11: Katsed süsteemse toksilisuse hindamiseks

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

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English 
Withdrawn
from
18.06.2018
13.92 EUR

Total: 56|Show all items

ISO 50001 koolitus ISO 45001