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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
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Valid |
8.72 EUR |
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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
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Valid |
4.79 EUR |
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Üldnõuded in vitro diagnostilistele enesekontrolli meditsiiniseadmetele
General requirements for in vitro diagnostic medical devices for self-testing
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English
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Valid |
6.47 EUR |
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In vitro diagnostiliste seadmete jõudluse hindamine
Performance evaluation of in vitro diagnostic medical devices
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English
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Valid |
9.49 EUR |
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In vitro diagnostiliste reaktiivide stabiilsuskatsetus
Stability testing of in vitro diagnostic reagents
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English
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Withdrawn |
7.38 EUR |
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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
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Valid |
6.47 EUR |
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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
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Valid |
8.01 EUR |
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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
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Valid |
8.01 EUR |
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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
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Valid |
10.19 EUR |
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Ühekordsed katsutid inimese veenivere proovide kogumiseks
Single-use containers for human venous blood specimen collection
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English
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Valid |
10.90 EUR |
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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
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Valid |
6.47 EUR |
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Meditsiinitarvikute steriliseerimine. Nõuded meditsiinitarvikutele vastavuseks märgistusele "Steriilne". Osa 2: Nõuded aseptiliselt töödeldud meditsiinitarvikutele
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
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Valid |
7.38 EUR |
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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
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Valid |
12.51 EUR |
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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
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Valid |
10.19 EUR |
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Meditsiiniseadmete tarkvara. Tarkvara elutsükli protsessid
Medical device software - Software life-cycle processes
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English
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Valid |
22.15 EUR |
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Meditsiiniseadmete tarkvara. Tarkvara elutsükli protsessid
Medical device software - Software life-cycle processes
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English
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Valid |
0.00 EUR |
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Meditsiiniseadmed. Meditsiiniseadmete kasutussobivuse rakendamine
Medical devices – Application of usability engineering to medical devices
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English
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Valid |
23.62 EUR |
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Tervishoiutoodete steriliseerimine. Kiirgus. Osa 2: Steriliseerimisdoosi määramine (ISO 11137-2:2012)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
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English
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Valid |
20.74 EUR |
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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
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Valid |
11.67 EUR |
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Tervishoiutoodete aseptiline töötlemine. Osa 1: Üldnõuded (ISO 13408-1:2008)
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
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English
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Valid |
18.00 EUR |