EN 12180:2000
(Main)Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants
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- Withdrawn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
- 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 - Medical devices
Relations
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 12180:2000 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants". This standard covers: 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.
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.
EN 12180:2000 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12180:2000 has the following relationships with other standards: It is inter standard links to EN ISO 14607:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12180:2000 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC, 98/79/EC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 12180:2000 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
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
...
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