EN 12180:2000

Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants

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.

Nichtaktive chirurgische Implantate - Weichteilimplantate - Besondere Anforderungen an Mammaimplantate

Diese Norm legt spezielle Anforderungen an Mammaimplantate zur klinischen Anwendung fest. Mit Bezug auf die Sicherheit legt sie Anforderungen an die beabsichtige Funktion, Konstruktionsmerkmale, Werkstoffe, Designprüfung, Herstellung, Sterilisation, Verpackung und vom Hersteller zu liefernde Informationen fest.

Implants chirurgicaux non actifs - Implants morphologiques - Exigences spécifiques relatives aux implants mammaires

La présente norme décrit les exigences spécifiques relatives aux implants mammaires à des fins cliniques. En ce qui concerne la sécurité, elle présente des exigences relatives aux performances prévues, à la conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant. NOTE: Au moment de la publication du présent document pour enquête, plusieurs méthodes d'essai prescrites dans les annexes sont en cours de validation. Pour le moment, une note de mise en garde est incluse, le cas échéant, dans les annexes.

Neaktivni kirurški vsadki (implantati) - Vsadki za oblikovanje telesa - Posebne zahteve za prsne vsadke

General Information

• Status: Withdrawn
• Publication Date: 15-Feb-2000
• Withdrawal Date: 14-Feb-2007
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285/WG 6 - Reconstructive implants
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Feb-2007
• Completion Date: 15-Feb-2007
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 12180:2000 - Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants

Relations

• Replaced By: EN ISO 14607:2007 - Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 12180:2000
01-november-2000
Neaktivni kirurški vsadki (implantati) - Vsadki za oblikovanje telesa - Posebne
zahteve za prsne vsadke
Non-active surgical implants - Body contouring implants - Specific requirements for
mammary implants
Nichtaktive chirurgische Implantate - Weichteilimplantate - Besondere Anforderungen an
Mammaimplantate
Implants chirurgicaux non actifs - Implants morpho
...