NF EN ISO 22442-2

NF EN ISO 22442-2

December 2020
Standard Current

Medical devices utilizing animal tissues and their derivatives - Part 2 : controls on sourcing, collection and handling

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1. NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats. This document does not cover the utilization of human tissues in medical devices. This document does not specify a quality management system for the control of all stages of production of medical devices.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2020

Number of pages

27 p.

Reference

NF EN ISO 22442-2

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S97-601-2

Print number

1

International kinship

ISO 22442-2:2020

European kinship

EN ISO 22442-2:2020
Sumary
Medical devices utilizing animal tissues and their derivatives - Part 2 : controls on sourcing, collection and handling

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.

NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.

This document does not cover the utilization of human tissues in medical devices.

This document does not specify a quality management system for the control of all stages of production of medical devices.

Replaced standards (1)
NF EN ISO 22442-2
July 2016
Standard Cancelled
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

<p>ISO 22442-2:2015 specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.</p> <p>NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management.</p> <p>The manufacturers should refer to ISO 22442‑3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents.</p> <p>ISO 22442-2:2015 does not cover the utilization of human tissues in medical devices.</p> <p>ISO 22442-2:2015 does not specify a quality management system for the control of all stages of production of medical devices.</p> <p>It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of a quality management system conforming to ISO 13485.</p> <p>NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.</p>

Table of contents
View the extract
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences générales
  • 5 Origine
  • 6 Collecte
  • 7 Traitement
  • 8 Stockage, transport et étiquetage
  • Annexe A (normative) Exigences supplémentaires relatives à l'application du présent document aux matériaux d'origine bovine et à d'autres espèces animales concernées par l'EST
  • Annexe B (informative) Certification et attestation Le format présenté dans les exemples de la présente annexe peut être copié.
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 93/42/CEE modifiée par le Règlement (UE) n° 722/2012 de la Commission
  • Bibliographie
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