Article 1
The references of harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 and listed in the Annex to this Decision are hereby published in the Official Journal of the European Union .
Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council
Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX No Reference of the standard 1. EN ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) 2. EN ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) EN ISO 11135:2014/A1:2019 3. 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) EN ISO 11137-1:2015/A2:2019 4. EN ISO 11737-2:2020 Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) 5. EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
Other acts of the same type
Council Decision (EU) 2018/385 of 16 October 2017 on the signing, on behalf of the Union and of the Member States, and provisional application of the Protocol to the Partnership and Cooperation Agreement establishing a partnership between the European Communities and their Member States, of the one part, and the Kyrgyz Republic, of the other part, to take account of the accession of the Republic of Croatia to the European UnionCouncil Decision (Euratom) 2018/386 of 16 October 2017 approving the conclusion, by the European Commission, on behalf of the European Atomic Energy Community, of the Protocol to the Partnership and Cooperation Agreement establishing a partnership between the European Communities and their Member States, of the one part, and the Kyrgyz Republic, of the other part, to take account of the accession of the Republic of Croatia to the European UnionCommission Decision (EU) 2018/884 of 16 October 2017 on aid measure SA.32874 (2012/C) (ex SA.32874 (2011/NN)) implemented by Denmark (notified under document C(2017) 4461) (Text with EEA relevance.)Commission Implementing Decision (EU) 2017/1857 of 13 October 2017 on the recognition of the legal, supervisory and enforcement arrangements of the United States of America for derivatives transactions supervised by the Commodity Futures Trading Commission as equivalent to certain requirements of Article 11 of Regulation (EU) No 648/2012 of the European Parliament and Council on OTC derivatives, central counterparties and trade repositories (Text with EEA relevance. )Council Decision of 12 October 2017 amending Decision 1999/70/EC concerning the external auditors of the national central banks, as regards the external auditors of the Banco de PortugalCouncil Implementing Decision (EU) 2017/1866 of 12 October 2017 on the launch of automated data exchange with regard to vehicle registration data in the Czech RepublicCouncil Implementing Decision (EU) 2017/1867 of 12 October 2017 on the launch of automated data exchange with regard to dactyloscopic data in PortugalCouncil Implementing Decision (EU) 2017/1868 of 12 October 2017 on the launch of automated data exchange with regard to dactyloscopic data in GreeceCouncil Decision (EU) 2017/1908 of 12 October 2017 on the putting into effect of certain provisions of the Schengen acquis relating to the Visa Information System in the Republic of Bulgaria and RomaniaCouncil Decision of 10 October 2017 adopting the Council’s position on draft amending budget No 5 of the European Union for the financial year 2017Council Decision (CFSP) 2017/1838 of 10 October 2017 amending Decision (CFSP) 2016/849 concerning restrictive measures against the Democratic People's Republic of KoreaCouncil Decision (EU) 2017/1849 of 10 October 2017 amending Decision 1999/70/EC concerning the external auditors of the national central banks, as regards the external auditors of Národná banka Slovenska
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
What to look at next
Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislationEU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and yearEuropean Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview