ISO/TS 37137-1:2021 PDF
Biological evaluation of absorbable medical devices — Part 1: General requirements
Biological evaluation of absorbable medical devices — Part 1: General requirements
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 12
- Дата публикации:
- 12 марта 2021 г.
- Издание:
- ISO TS 37137 edition 1 version 1
- ICS:
- 11.040.40
This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).
Abstract
Overview
ISO/TS 37137-1:2021 - "Biological evaluation of absorbable medical devices - Part 1: General requirements" provides guidance for performing biological risk assessments of within the framework. The technical specification clarifies key terms such as , , , and (see Annex A) and sets expectations for identification, characterization and testing of materials and their degradation products throughout the device lifecycle.
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