ISO 10993-11:2017 PDF
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 29
- Дата публикации:
- 14 сентября 2017 г.
- Издание:
- ISO IS 10993 edition 3 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
ISO 10993-11:2017 - "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity" provides requirements and guidance for evaluating the potential of medical device materials to cause . Part of the biocompatibility series, this standard addresses systemic toxicity from absorbed leachables and breakdown products rather than local effects. It supports preclinical risk assessment, test selection, study design and reporting for acute and repeated‑exposure systemic toxicity testing.
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