M/320 - Breast implants
Standardization mandate to CEN concerning the development of European standards relating to medical devices (subject: breast implants)
General Information
This document 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.
- Standard54 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard54 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard37 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft38 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard37 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft38 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
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).
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day