# Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/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 11990-1:2014
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)
4.
EN ISO 11990-2:2014
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)
5.
EN ISO 13408-2:2011
Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
6.
EN ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
EN ISO 13485:2016/AC:2016
7.
EN 13976-2:2011
Rescue systems - Transportation of incubators - Part 2: System requirements
8.
EN 14683:2005
Surgical masks - Requirements and test methods
9.
EN ISO 15747:2011
Plastic containers for intravenous injections (ISO 15747:2010)
10.
EN ISO 15883-4:2009
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
11.
EN ISO 17664:2004
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
12.
EN ISO 21987:2009
Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009)

---
Source: https://www.legislation.gov.uk/eudn/2020/437/annex/II (the official version)
Page: https://openlegislation.uk/eu-decision-2020-437/annex-II
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.