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M/320 - Breast implants

Standardization mandate to CEN concerning the development of European standards relating to medical devices (subject: breast implants)

General Information

Organization
CEN - CEN European Committee for Standardization
Status
Confirmed
Resolution Reference
CEN/BT C95/2002
Resolution Date
11-Feb-2003
Type Of Decision
(Dis-)Approval of mandate

Frequently Asked Questions

A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.

M/320 is a European Standardization Mandate titled "Standardization mandate to CEN concerning the development of European standards relating to medical devices (subject: breast implants)". Standardization mandate to CEN concerning the development of European standards relating to medical devices (subject: breast implants) There are 6 standards developed under this mandate.

Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.

Standardization Organization
ICS
Technical Committee
Directive
50
CEN
EN ISO 14607:2018(Main)
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
SIST EN ISO 14607:2018

ISO 14607:2018 specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.

  • Standard
    55 pages
    English language
    e-Library read for
    1 day
  • Standard
    54 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 14607:2018(Main)
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
EN ISO 14607:2018

ISO 14607:2018 specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.

  • Standard
    54 pages
    English language
    e-Library read for
    1 day
  • Standard
    55 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 14607:2009(Main)
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
SIST EN ISO 14607:2009

ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

  • Standard
    37 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 14607:2009(Main)
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
EN ISO 14607:2009

ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

  • Standard
    37 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 14607:2007(Main)
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
EN ISO 14607:2007

This International Standard specifies particular requirements for mammary implants for clinical practice. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

  • Standard
    36 pages
    English language
    e-Library read for
    1 day
CEN
EN ISO 14607:2007(Main)
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
SIST EN ISO 14607:2007

BT noted  that this work in TC285 level depends on new funding by the European Commission. See document BT C 95/2002 (BT N6734) ++ Registered under VA/CEN lead further to info from ISO/CS (NT/030520).

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