SIST 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:
- 18 июля 2018 г.
- ICS:
- 11.100.20
- Технический комитет:
- VAZ - Healthcare
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
SIST EN :2018 () - "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 :2018), it supports conformity assessment for EU medical device directives and is part of the biocompatibility series.
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