ISO/TS 37137-1:2021

Name: ISO/TS 37137-1:2021
Brand: ISO
SKU: ISO/TS 37137-1:2021
Price: 76.23 EUR
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Biological evaluation of absorbable medical devices — Part 1: General requirements

Publication date: Mar 12, 2021

General information

Current stage: 90.20 Standard under periodical review Jan 15, 2024

Originator: ISO

Owner: ISO/TC 194 Biological and clinical evaluation of medical devices

Type: Technical Specification

ICS: 11.040.40 Implants for surgery, prosthetics and orthotics

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Status: Published

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Languages: English

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Scope

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).

Life cycle

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PUBLISHED
ISO/TS 37137-1:2021
90.20 Standard under periodical review
Jan 15, 2024