EN ISO 14602:2010

Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)

Publication date:   Dec 17, 2010

General information

99.60 Withdrawal effective   Oct 19, 2011

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 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.
In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

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WITHDRAWN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 14602:2009

NOW

WITHDRAWN
EN ISO 14602:2010
99.60 Withdrawal effective
Oct 19, 2011

REVISED BY

PUBLISHED
EN ISO 14602:2011