EN ISO 7439:2011

Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2011)

Publication date:   Aug 17, 2011

General information

99.60 Withdrawal effective   Apr 15, 2015

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.200   Birth control. Mechanical contraceptives

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Scope

ISO 7439:2010 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. (Some aspects can be applicable to medicated intrauterine devices and IUDs not containing copper.)
It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 7439:2009

NOW

WITHDRAWN
EN ISO 7439:2011
99.60 Withdrawal effective
Apr 15, 2015

REVISED BY

WITHDRAWN
EN ISO 7439:2015