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
Current Stage
9020 - International Standard under periodical review
Start Date
15-Jan-2024
Completion Date
15-Jan-2024
Ref Project

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ISO/TS 37137-1:2021 - Biological evaluation of absorbable medical devices
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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

---------------------- Page: 1 ----------------------
ISO/TS 37137-1:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

---------------------- Page: 2 ----------------------
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 .
...

TECHNICAL ISO/TS
SPECIFICATION 37137-1
First edition
Biological evaluation of absorbable
medical devices —
Part 1:
General guidance
PROOF/ÉPREUVE
Reference number
ISO/TS 37137-1:2020(E)
©
ISO 2020

---------------------- Page: 1 ----------------------
ISO/TS 37137-1:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 37137-1:2020(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 . 7
8.12 ISO 10993-12, sample preparation and re
...

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