EN ISO 14602:2011

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

Publication date:   Feb 17, 2012

General information

60.60 Standard published   Oct 19, 2011

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

Buying

  Published

PDF - €36.30

  English  



Buy

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

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

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

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 14602:2010

NOW

PUBLISHED
EN ISO 14602:2011
60.60 Standard published
Oct 19, 2011

Relations

Adopted from ISO 14602:2010 IDENTICAL