EN ISO 7439:2015

Name: EN ISO 7439:2015
Brand: CEN

Withdrawn

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

Withdrawn date

10-31-2015

Published date

04-15-2015

Publisher

Comite Europeen de Normalisation

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Status	Withdrawn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