# Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC, Annex II

Extent: E+W+S+N.I.

No
Reference of the standard
1.
EN ISO 10993-11:2009
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
2.
EN ISO 11137-1:2015
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
3.
EN ISO 13408-2:2011
Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
4.
EN ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
EN ISO 13485:2016/AC:2016

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Source: https://www.legislation.gov.uk/eudn/2020/438/annex/II (the official version)
Page: https://openlegislation.uk/eu-decision-2020-438/annex-II
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.