EN ISO 7439:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
10-31-2015
04-15-2015
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Withdrawn
|
| Standards | Relationship |
| ONORM EN ISO 7439 : 2015 | Identical |
| DS EN ISO 7439 : 2015 | Identical |
| ISO 7439:2015 | Identical |
| NBN EN ISO 7439 : 2015 | Identical |
| NEN EN ISO 7439 : 2015 | Identical |
| NS EN ISO 7439 : 2015 | Identical |
| I.S. EN ISO 7439:2015 | Identical |
| PN EN ISO 7439 : 2015 | Identical |
| SN EN ISO 7439 : 2015 | Identical |
| UNI EN ISO 7439 : 2011 | Identical |
| SS-EN ISO 7439 : 2015 | Identical |
| UNI EN ISO 7439 : 2015 | Identical |
| UNE-EN ISO 7439:2015 | Identical |
| BS EN ISO 7439:2015 | Identical |
| NF EN ISO 7439 : 2015 | Identical |
| DIN EN ISO 7439:2015-08 | 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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