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EN ISO 7439:2015

Withdrawn

Withdrawn

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)

Published date

04-15-2015

Withdrawn date

10-31-2015

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing and inspection
9 Sterilization
10 Packaging
11 Information to be supplied by the manufacturer
Bibliography

ISO 7439:2015 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments.It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

Committee
CEN/TC 285
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

ISO 14155-1:2003 Clinical investigation of medical devices for human subjects — Part 1: General requirements
ISO 14630:2012 Non-active surgical implants — General requirements
EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 14971:2007 Medical devices — Application of risk management to medical devices
ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

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