NA 027

DIN Standards Committee Optics and Precision Mechanics

Project

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

Abstract

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, using available information, the safety of such devices by estimating and evaluating the resulting risks, controlling these risks and monitoring the effectiveness of that control.

Begin

2021-05-18

WI

00206082

Planned document number

DIN EN ISO 22442-1

Project number

02703295

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 

previous edition(s)

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
2021-04

Order from Beuth Verlag

Contact

Dipl.-Ing. (FH)

Petra Bischoff

Alexander-Wellendorff-Str. 2
75172 Pforzheim

Tel.: +49 7231 9188-31
Fax: +49 7231 9188-33

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