DIN EN ISO 22442-1:2021
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020

Standard No.
DIN EN ISO 22442-1:2021
Release Date
2021
Published By
German Institute for Standardization
Status
Replace By
DIN EN ISO 22442-1:2016
DIN EN ISO 22442-1:2018
DIN EN ISO 22442-1:2021-08
Latest
DIN EN ISO 22442-1:2016
DIN EN ISO 22442-1:2018
DIN EN ISO 22442-1:2021-08
Replace
DIN EN ISO 22442-1
Scope
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 non-viable. It specifies, in conjunction with ISO 14971, a procedure to investigate, usin

DIN EN ISO 22442-1:2021 history

  • 2021 DIN EN ISO 22442-1:2021 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020
  • 1970 DIN EN ISO 22442-1 E:2018-09 Animal tissues and their derivatives for use in medical devices Part 1: Application of risk management (draft)
  • 2018 DIN EN ISO 22442-1 E:2018 Draft Document - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2018); German and English version prEN ISO 22442-1:2018
  • 2016 DIN EN ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version EN ISO 22442-1:2015
  • 1970 DIN EN ISO 22442-1 E:2015-08 Animal tissues and their derivatives for use in medical devices Part 1: Application of risk management (draft)
  • 0000 DIN EN ISO 22442-1:2015
  • 2008 DIN EN ISO 22442-1:2008 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); English version of DIN EN ISO 22442-1:2008-03
  • 0000 DIN EN ISO 22442-1:2006
  • 0000 DIN EN 12442-1:2001
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020



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