I.S. EN ISO 7439:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS (ISO 7439:2015)
Hardcopy , PDF
20-04-2023
English
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.
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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
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Superseded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 |
| Standards | Relationship |
| ONORM EN ISO 7439 : 2015 | Identical |
| BS EN ISO 7439:2015 | Identical |
| UNI EN ISO 7439 : 2011 | Identical |
| EN ISO 7439:2015 | Identical |
| NBN EN ISO 7439 : 2015 | Identical |
| NEN EN ISO 7439 : 2015 | Identical |
| NS EN ISO 7439 : 2015 | Identical |
| DIN EN ISO 7439:2015-08 | Identical |
| SN EN ISO 7439 : 2015 | Identical |
| UNE-EN ISO 7439:2015 | Identical |
| ISO 7439:2015 | Identical |
| NF EN ISO 7439 : 2015 | Identical |
| 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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