Article 1
Open ↗Annex I to Implementing Decision (EU) 2020/439 is amended in accordance with the Annex to this Decision.
Source
Commission Implementing Decision (EU) 2021/609 of 14 April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products
Commission Implementing Decision (EU) 2021/609 of 14 April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products
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
Open ↗This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
Open ↗ANNEX Annex I is amended as follows: (1) entry 5 is replaced by the following: No Reference of the standard ‘5. 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)’; (2) the following entries 42 and 43 are added: No Reference of the standard ‘42. EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) 43. EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)’.
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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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