DIN Standards Committee Optics and Precision Mechanics
DIN EN ISO 22442-1
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
Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden - Teil 1: Anwendung des Risikomanagements (ISO 22442-1:2015); Deutsche Fassung EN ISO 22442-1:2015
Overview
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. The committee responsible for this standard is NA 027-02-21 AA "Medizinische Produkte auf Basis des Tissue Engineering" ("Medical devices utilizing tissues") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 027-05-10 AA - Medical devices utilizing tissues
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
Responsible international committee
ISO/TC 194 - Biological and clinical evaluation of medical devices