This standard describes specific requirements for mammary implants for clinical practice. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. NOTE: At the time of publication of this document for enquiry several test methods specified in the annexes were being validated. For the time being, where appropriate, disclosure statements are included in these annexes.
Registration number (WIID)
14206
Scope
This standard describes specific requirements for mammary implants for clinical practice. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. NOTE: At the time of publication of this document for enquiry several test methods specified in the annexes were being validated. For the time being, where appropriate, disclosure statements are included in these annexes.
