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98/79/EC - In vitro diagnostic medical devices

Format Name Language Status
Electronic Paper 

EVS-EN 12322:1999

In vitro kasutatavad diagnostilised meditsiiniseadmed. Mikrobioloogia sööde. Söötme esitluskriteeriumid

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

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English 
Valid
from
01.01.2000
8.72 EUR
Electronic Paper 

EVS-EN 12322:1999/A1:2002

In vitro kasutatavad diagnostilised meditsiiniseadmed. Mikrobioloogia sööde. Söötme esitluskriteeriumid. MUUDATUS

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media - AMENDMENT

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English
Valid
from
06.05.2002
4.78 EUR
Electronic Paper 

EVS-EN 13532:2002

Üldnõuded in vitro diagnostilistele enesekontrolli meditsiiniseadmetele

General requirements for in vitro diagnostic medical devices for self-testing

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English 
Valid
from
01.06.2002
6.47 EUR
Electronic Paper 

EVS-EN 13612:2002

In vitro diagnostiliste seadmete jõudluse hindamine

Performance evaluation of in vitro diagnostic medical devices

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English 
Valid
from
01.09.2002
9.49 EUR
Electronic Paper 

EVS-EN 13641:2002

In vitro diagnostiliste reaktiividega seotud infektsiooniriski kõrvaldamine või vähendamine

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

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English 
Valid
from
01.07.2002
6.47 EUR
Electronic Paper 

EVS-EN 13975:2003

Diagnostiliste in vitro meditsiiniseadmete vastuvõtul teostatava testimise osaks olevad proovivõtumeetodid. Statistilised aspektid

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

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English 
Valid
from
01.05.2003
8.01 EUR
Electronic Paper 

EVS-EN 14136:2004

Väliste kvaliteedihindamissüsteemide kasutamine in vitro diagnostiliste kontrollimisprotseduuride toimimisnäitajate hindamisel

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

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English 
Valid
from
09.09.2004
8.01 EUR
Electronic Paper 

EVS-EN 14254:2004

In vitro meditsiinilised diagnostikaseadmed. Ühekordselt kasutatavad anumad verest erinevate proovide võtmiseks inimestelt

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

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English 
Valid
from
12.10.2004
10.19 EUR
Electronic Paper 

EVS-EN 14820:2004

Ühekordsed katsutid inimese veenivere proovide kogumiseks

Single-use containers for human venous blood specimen collection

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English 
Withdrawn
from
18.09.2017
10.90 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 Paper 

EVS-EN 61010-2-101:2003

Ohutusnõuded mõõtmise, kontrolli ja laborikasutuse elektriseadmestikule. Osa 2- 101: Erinõuded in vitro diagnostilisele (IVD) meditsiiniseadmestikule

Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

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English 
Withdrawn
from
02.03.2017
12.51 EUR
Electronic Paper 

EVS-EN 61326-2-6:2006

Mõõte-, juhtimis- ja laboratooriumi-elektriseadmed. Elektromagnetilise ühilduvuse nõuded. Osa 2-6: Erinõuded. Meditsiiniseadmete diagnostika in vitro

Electrical equipment for measurement, control and laboratory use – EMC requirements Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment

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English 
Withdrawn
from
04.07.2013
10.19 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 62366:2008

Meditsiiniseadmed. Meditsiiniseadmete kasutussobivuse rakendamine

Medical devices – Application of usability engineering to medical devices

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English 
Withdrawn
from
05.01.2016
23.62 EUR
Electronic Paper 

EVS-EN ISO 11137-1:2015

Tervishoiutoodete steriliseerimine. Kiirgus. Osa 1: Nõuded meditsiiniseadmete steriliseerimisprotsessi väljatöötamisele, valideerimisele ja tavakontrollile

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

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English 
Valid
from
02.07.2015
18.00 EUR
Electronic Paper 

EVS-EN ISO 11137-2:2015

Tervishoiutoodete steriliseerimine. Kiirgus. Osa 2: Steriliseerimisdoosi määramine

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

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English 
Valid
from
02.07.2015
20.74 EUR
Electronic Paper 

EVS-EN ISO 11737-2:2010

Meditsiiniseadmete steriliseerimine. Mikrobioloogilised meetodid. Osa 2: Steriilsuskatsed steriliseerimisprotsessi määratlemisel, valideerimisel ja rakendamisel

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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English 
Valid
from
04.03.2010
11.67 EUR
Electronic Paper 

EVS-EN ISO 13408-1:2015

Tervishoiutoodete aseptiline töötlemine. Osa 1: Üldnõuded

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

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English 
Valid
from
02.07.2015
19.05 EUR

Total: 44|Show all items

IEC 31010 Koolitus_17025