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Norm

ISO 22442-1:2007

Ausgabedatum: 2007 11 27

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

ISO 22442-1:2007 applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have...
ZURÜCKGEZOGEN: 2015 11 02
Herausgeber:
International Organization for Standardization
Format:
Digital | 26 Seiten
Sprache:
Englisch

ISO 22442-1:2007 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 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. ISO 22442-1:2007 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:

  • contamination by bacteria, moulds or yeasts;
  • contamination by viruses;
  • contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
  • material responsible for undesired pyrogenic, immunological or toxicological reactions.
ISO 22442-1:2020
2020 09 15
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk managem...
Norm
ISO 22442-1:2015
2015 11 02
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk managem...
Norm
ISO 22442-1:2007
2007 11 27
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk managem...
Norm
Norm
ISO 22442-1:2015
Ausgabedatum : 2015 11 02
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management