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SRPS EN ISO 14602:2011

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

Sep 30, 2011
95.99   Withdrawal of Standard   Feb 28, 2013

General information

95.99     Feb 28, 2013

ISS

Z076

European Norm

11.040.40  

English  

From plan 2011

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Directive 93/42/EEC
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

Directive 2007/47/EC

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 14602:2011
95.99 Withdrawal of Standard
Feb 28, 2013

REVISED BY

PUBLISHED
SRPS EN ISO 14602:2013

Related project

Adopted from EN ISO 14602:2010

Adopted from ISO 14602:2010 IDENTICAL