DIN EN ISO 22442-2:2016-05

Superseded

View Superseded by

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)

Available format(s)

Hardcopy , PDF

Superseded date

08-04-2021

Language(s)

German, English

Published date

01-05-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DevelopmentNote	Supersedes DIN EN 12442-2. (03/2008)
DocumentType	Standard
Pages	27
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 22442-2:2021-04
Supersedes	DIN EN 12442-2:1998-05 (Draft) DIN EN ISO 22442-2:2008-03

Standards	Relationship
ISO 22442-2:2015	Identical
BS EN ISO 22442-2:2015	Identical
NEN EN ISO 22442-2 : 2015	Identical
EN ISO 22442-2:2015	Identical
NF EN ISO 22442-2 : 2016	Identical
NBN EN ISO 22442-2 : 2015	Identical
NS EN ISO 22442-2 : 2007	Identical
SN EN ISO 22442-2 : 2016	Identical
I.S. EN ISO 22442-2:2015	Identical
ONORM EN ISO 22442-2 : 2016	Identical

DIN EN ISO 11135:2014-10	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
DIN EN ISO 5840-3:2013-06	Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
DIN EN ISO 22442-1:2016-05	Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
DIN EN ISO 22442-3:2008-03	MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
DIN ISO 13022:2014-06	MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
DIN EN ISO 20857:2013-08	Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
DIN EN ISO 14630:2013-03	Non-active surgical implants - General requirements (ISO 14630:2012)
DIN EN ISO 14160:2011-10	Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
DIN EN ISO 11137-1:2015-11	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)

ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 22442-1:2015	Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
ISO 9001:2015	Quality management systems — Requirements
ISO 22442-3:2007	Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO 14971:2007	Medical devices Application of risk management to medical devices
DIN EN ISO 22442-1:2016-05	Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)