Need help?

EN ISO 22442-1:2007 Standard

wave
Save  

  Keywords:

#medical #contamination #viable #hazards #control

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)

  Purpose

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 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. For parasites and other unclassified pathogenic entities, similar principles can apply.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN 12442-1:2000"

Anyway is still possible use the "EN 12442-1:2000" until June 30th, 2008

  Related Standards

EN ISO 9170-2:2008

Medical devices Directive (93/42/EEC)

Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

EN 60601-2-3:1993

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipmentIEC 60601-2-3:1991

EN 60601-2-12:2006

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilatorsIE...

EN 60601-2-11:1997/A1:2004 (IEC 60601-2-11:1997/A1:2004)

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipmentIEC 60601-2-11:199...

EN 60601-2-11:1997

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipmentIEC 60601-2-11:199...

EN 60601-2-10:2000/A1:2001 (IEC 60601-2-10:1987/A1:2001)

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulatorsIEC 60601-2-10:198...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 22442-1:2007 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0