SIST EN ISO 10993-5:2009/A11:2025
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 6
- Дата публикации:
- 2 апреля 2025 г.
- ICS:
- 11.100.20
- Технический комитет:
- VAZ - Healthcare
Abstract
Overview
EN ISO 10993-5:2009/A11:2025 is a CEN amendment to the international standard for the biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. Published March 2025, Amendment A11 updates the European foreword and Annex ZA to clarify the relationship between in vitro cytotoxicity testing and the General Safety and Performance Requirements of Regulation (EU) 2017/745 (MDR). The amendment supports harmonized evaluation of material- and substance‑related cytotoxic effects on mammalian cells and establishes its role in regulatory conformity assessments when cited in the Official Journal of the EU.
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