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CEN

CEN/TC 285/WG 5 - Osteosynthesis

To draft and review standards on osteosynthesis.

Osteosynthesis

To draft and review standards on osteosynthesis.

General Information

Status
Inactive
Parent
CEN/TC 285 - Non-active surgical implants

Frequently Asked Questions

CEN/TC 285/WG 5 is a Working Group within the European Committee for Standardization (CEN). It is named "Osteosynthesis" and is responsible for: To draft and review standards on osteosynthesis. This committee has published 4 standards.

CEN/TC 285/WG 5 develops CEN standards. The scope of work includes: To draft and review standards on osteosynthesis. Currently, there are 4 published standards from this working group.

The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.

A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.

Standardization Organization
ICS
Directive
Mandate
50
CEN
EN ISO 14602:2011(Main)
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
SIST EN ISO 14602:2012

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.

  • Standard
    23 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 14602:2010(Main)
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
SIST EN ISO 14602:2010

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.

  • Standard
    22 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 14602:2009(Main)
Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
SIST EN ISO 14602:2009

This European standard specifies particular requirements for non-active surgical Implants for osteosynthesis, hereafter referred to as implants. In addition to EN ISO 14630:1997, this standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.

  • Standard
    20 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 14602:1998(Main)
Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
SIST EN ISO 14602:2000

This European standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants.  In addition to EN ISO 14630:1997, this standard gives particular requirements for intended performance, design attributes,  materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer.

  • Standard
    14 pages
    English language
    e-Library read for
    1 day
50