EN ISO 10993-11:2018 PDF
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 43
- Дата публикации:
- 30 мая 2018 г.
- Издание:
- CEN EN 10993 edition 2 version 1
- ICS:
- 11.100.20
ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
Abstract
Overview
EN ISO 10993-11:2018 (ISO 10993-11:2017) - "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity" - specifies requirements and provides guidance on procedures to evaluate the potential of medical device materials to cause . Endorsed as a European standard (EN ISO 10993-11:2018), it supports conformity assessment for EU medical device directives and is part of the ISO 10993 biocompatibility series.
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