Standard Svensk standard · SS-EN ISO 22442-1:2015

Medicintekniska produkter som innehåller vävnader från djur och derivat därav - Del 1: Tillämpning av riskhantering (ISO 22442-1:2015)

Status: Upphävd

· Ersätts av: SS-EN ISO 22442-1:2020
Köp denna standard

Standard Svensk standard · SS-EN ISO 22442-1:2015

Medicintekniska produkter som innehåller vävnader från djur och derivat därav - Del 1: Tillämpning av riskhantering (ISO 22442-1:2015)
Prenumerera på standarden - Läs mer Dölj
Pris: 1 320 SEK
standard ikon pdf

PDF

Pris: 1 320 SEK
standard ikon

Papper

Pris: 2 112 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ
Provläs denna standard
Omfattning
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 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 asa) 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.For parasites and other unclassified pathogenic entities, similar principles can apply.This part of ISO 22442 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices.This part of ISO 22442 does not cover the utilization of human tissues in medical devices.

Ämnesområden

Biologisk värdering av medicintekniska produkter (11.100.20) Övrigt (11.100.99)


Köp denna standard

Standard Svensk standard · SS-EN ISO 22442-1:2015

Medicintekniska produkter som innehåller vävnader från djur och derivat därav - Del 1: Tillämpning av riskhantering (ISO 22442-1:2015)
Prenumerera på standarden - Läs mer Dölj
Pris: 1 320 SEK
standard ikon pdf

PDF

Pris: 1 320 SEK
standard ikon

Papper

Pris: 2 112 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ

Produktinformation

Språk: Engelska

Framtagen av: Biologisk säkerhet, SIS/TK 340/AG 02

Internationell titel: Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)

Artikelnummer: STD-8017738

Utgåva: 2

Fastställd: 2015-12-01

Antal sidor: 44

Ersätter: SS-EN ISO 22442-1:2007

Ersätts av: SS-EN ISO 22442-1:2020