Draft standardisation request as regards medical devices and in vitro diagnostic medical devices
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Article 1 Requested standardisation activities
1. The European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are requested to revise the existing standards listed in Table 1 of Annex I to this Decision and to draft new standards listed in Table 2 of that Annex in support of Regulation (EU) 2017/745.
2. CEN and Cenelec are requested to revise the existing standards listed in Table 1 of Annex II to this Decision and to draft new standards listed in Table 2 of that Annex in support of Regulation (EU) 2017/746.
3. If, after the date of this Decision and prior to execution of the present request for any particular standard listed in Table 1 of Annex I or Table 1 in Annex II, CEN or Cenelec publishes a new version of that standard or an amendment to that standard, it shall consult the Commission as to whether the new version of the standard could be used as a basis for execution of the request, and whether a modification of Annex I or Annex II is needed.
4. The standards referred to in the first and second paragraph shall meet the requirements set.
[...]
Article 4 Development of standardsout in Annex III.
1. CEN and Cenelec shall include in each standard a clear and precise description of the relationship between its content and the corresponding requirements set out in Regulation (EU) 2017/745 or Regulation (EU) 2016/746 that it aims to cover.
2. Each standard developed on the basis of the request referred to in Article 1 shall refer to this Decision.
3. CEN and Cenelec shall include in each existing standard revised in accordance with Article 1 information on significant changes introduced in the standard following the revision of the standard on the basis of this Decision.
4. CEN and Cenelec shall provide the Commission with the titles of the requested standards in all official languages of the Union.
ANNEX I
List of existing standards to be revised and list of new standards to be drafted in support of Regulation (EU) 2017/745 as referred to in Article 1
Table 1: List of existing standards to be revised and deadlines for their adoption
|
Reference information |
Deadline for the adoption by the ESOs |
|
| 1. |
EN 556-1:2001+AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
27/5/2024 |
| 2. |
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices |
27/5/2024 |
| 3. |
EN ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
27/5/2024 |
| 4. |
EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
27/5/2024 |
| 5. |
EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood |
27/5/2024 |
| 6. |
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
27/5/2024 |
| 7. |
EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation |
27/5/2024 |
| 8. |
EN ISO 10993-7:2008+AC:2009 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals |
27/5/2024 |
| 9. |
EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products |
27/5/2024 |
| 10. |
EN ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
27/5/2024 |
| 11. |
EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
27/5/2024 |
...segue in allegato
Fonte: EU
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