ISO/TS 37137-1:2021

Biological evaluation of absorbable medical devices — Part 1: General requirements

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).

Évaluation biologique des dispositifs médicaux résorbables — Partie 1: Exigences générales

General Information

• Status: Published
• Publication Date: 11-Mar-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 194 - Biological and clinical evaluation of medical devices
• Drafting Committee: ISO/TC 194/WG 2 - Degradation aspects related to biological testing
• Current Stage: 9060 - Close of review
• Start Date: 02-Sep-2027

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 37137-1
First edition
2021-03
Biological evaluation of absorbable
medical devices —
Part 1:
General requirements
Évaluation biologique des dispositifs médicaux résorbables —
Partie 1: Exigences générales
Reference number
ISO/TS 37137-1:2021(E)
©
ISO 2021

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ISO/TS 37137-1:2021(E)

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ISO/TS 37137-1:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations . 2
5 Test article considerations . 4
6 Sterilization considerations . 4
7 Drug-device combination product considerations . 4
8 E valuation of absorbable medical devices in the context of the ISO 10993 series .4
8.1 General . 4
8.2 ISO 10993-1, evaluation and testing within a risk management process . 5
8.3 ISO 10993-2, animal welfare requirements . 5
8.4 ISO 10993-3, tests for genotoxicity, carcinogenicity, and reproductive toxicity . 5
8.5 ISO 10993-4, selection of tests for interactions with blood . 6
8.6 ISO 10993-5, tests for in vitro cytotoxicity . 6
8.7 ISO 10993-6, Tests for local effects after implantation . 6
8.8 ISO 10993-7, ethylene oxide sterilization residuals . 7
8.9 ISO 10993-9, framework for identification and quantification of potential
degradation products . 7
8.10 ISO 10993-10, tests for skin sensitization. 7
8.11 ISO 10993-11, tests for systemic toxicity .
...