Standard Svensk standard · SS-EN ISO 14630:2009

Icke aktiva kirurgiska implantat - Allmänna krav (ISO 14630:2008)

Status: Upphävd

· Ersätts av: SS-EN ISO 14630:2012
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Standard Svensk standard · SS-EN ISO 14630:2009

Icke aktiva kirurgiska implantat - Allmänna krav (ISO 14630:2008)
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Omfattning
This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards. NOTE This International Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure the implant achieves its intended performance.

Ämnesområden

Kirurgiska implantat, proteser och ortoser (11.040.40)


Köp denna standard

Standard Svensk standard · SS-EN ISO 14630:2009

Icke aktiva kirurgiska implantat - Allmänna krav (ISO 14630:2008)
Prenumerera på standarden - Läs mer Dölj
Pris: 875 SEK
standard ikon pdf

PDF

Pris: 875 SEK
standard ikon

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Produktinformation

Språk: Engelska

Framtagen av: Implantat, SIS/TK 340/AG 03

Internationell titel: Non-active surgical implants - General requirements (ISO 14630:2008)

Artikelnummer: STD-69797

Utgåva: 4

Fastställd: 2009-05-25

Antal sidor: 32

Ersätter: SS-EN ISO 14630:2008

Ersätts av: SS-EN ISO 14630:2012