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I.S. EN ISO 7439:2015

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015)

Available format(s)

Hardcopy , PDF

Superseded date

04-20-2023

Language(s)

English

Published date

01-01-2015

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Defines requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments.

DocumentType
Standard
Pages
26
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

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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