EN ISO 14630:2009

Non-active surgical implants - General requirements (ISO 14630:2008)

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Dec 1, 2012

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

ISO 14630:2008 specifies general requirements for non-active surgical implants. ISO 14630:2008 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, ISO 14630:2008 gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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WITHDRAWN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 14630:2008

NOW

WITHDRAWN
EN ISO 14630:2009
99.60 Withdrawal effective
Dec 1, 2012

REVISED BY

PUBLISHED
EN ISO 14630:2012

Relations

Adopted from ISO 14630:2008 IDENTICAL