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SRPS EN ISO 14602:2013

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

Feb 28, 2013

General information

60.60     Feb 28, 2013

ISS

Z076

European Norm

11.040.40  

English  

Van plana

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Published

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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

Harmonized
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
2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Directive 2017/745

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 14602:2011

NOW

PUBLISHED
SRPS EN ISO 14602:2013
60.60 Standard published
Feb 28, 2013

Related project

Adopted from EN ISO 14602:2011

Adopted from ISO 14602:2010 IDENTICAL