Need help?

EN ISO 22442-2:2007 Standard

wave
Save  

  Keywords:

#medical #contamination #risk #risks #control

This standard is superseded by:
  •   EN ISO 22442-2:2020
  •   This standard is no longer addressed in the last official Journal publication of the "2021-04-14 ". This standard is addressed for the last time in the official journal publication of the "2020-03-25"

      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 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)

      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

      Cessation

    This standard has been withdrawn on 2021-04-14

      Reference

    This standard supersedes the "EN 12442-2:2000"

    Anyway is still possible use the "EN 12442-2:2000" until June 30th, 2008

      Related Standards

    EN 1642:2011

    Medical devices Directive (93/42/EEC)

    Dentistry - Medical devices for dentistry - Dental implants

    EN ISO 13408-1:2015

    Medical devices Directive (93/42/EEC)

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

    EN 13624:2003

    Medical devices Directive (93/42/EEC)

    Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinf...

    EN ISO 13485:2016/AC:2016

    Medical devices Directive (93/42/EEC)

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    EN ISO 13485:2016

    Medical devices Directive (93/42/EEC)

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    EN ISO 13408-7:2015

    Medical devices Directive (93/42/EEC)

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

      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 22442-2:2007 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