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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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

Hardcopy , PDF

Superseded date

20-04-2023

Language(s)

English

Published date

01-01-2015

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.


Dates of withdrawal of national standards are available from NSAI.

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Superseded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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