Tagasi

EVS-EN ISO 22442-1:2015

Meditsiiniseadmed, mis kasutavad loomseid kudesid ja nende derivaate. Osa 1: Riskijuhtimise rakendamine

Üldinfo
Kehtetu alates 31.12.2020
Alusdokumendid
ISO 22442-1:2015; EN ISO 22442-1:2015
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
31.12.2020
Põhitekst
05.01.2016
Põhitekst
07.02.2008
Põhitekst
EVS-EN ISO 22442-1:2008
This part of ISO 22442 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered nonviable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This part of ISO 22442 is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply.
*
*
*
PDF
17,63 € koos KM-ga
Paber
17,63 € koos KM-ga
Hind: 2,40 € koos KM-ga
Standardi monitooring
Teised on ostnud veel
Põhitekst

EVS-EN ISO 22442-2:2015

Meditsiiniseadmed, mis kasutavad loomseid kudesid ja nende derivaate. Osa 2: Hankimise, kogumise ja käitluse ohje
Kehtetu alates 31.12.2020
Põhitekst

EVS-EN ISO 22442-3:2008

Meditsiiniseadmete valmistamisel kasutatavad loomsed koed ja nende tuletised. Osa 3: Viiruste ja muude ülekantavate toimeainete kõrvaldamise ja/või inaktiveerimise valideerimine
Uusim versioon Kehtiv alates 07.02.2008
Põhitekst

EVS-EN ISO 14644-1:2015

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
Uusim versioon Kehtiv alates 05.01.2016
Põhitekst

EVS-EN ISO 14644-2:2015

Cleanrooms and associated controlled environments - Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1 (ISO 14644-2:2015)
Uusim versioon Kehtiv alates 05.01.2016