Aktívna norma | Vydaná: 03.01.2018

ISO/TR 14283:2018-ed.3.0

Implants for surgery — Essential principles of safety and performance
(Implants chirurgicaux — Principes essentiels de la sécurité et les performances)

Dostupné jazyky: Anglicky

Dostupné prevedenie: Elektronické PDF, Tlačené

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Podrobné informácie

Označenie: ISO/TR 14283:2018-ed.3.0

Dátum vydania: 03.01.2018

Stránok: 20

Krajina: Medzinárodná technická norma

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Anotácia

Description / Abstract: ISO/TR 14283:2017 provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose. ISO/TR 14283:2017 is often the case that instruments and other equipment are used in association with implants. These devices might be useful or even essential for the safe implantation and/or use of the implants. This document applies to implants, however, it also applies to associated instruments and equipment to the extent that the design and manufacture of the implants is intended to ensure the safe combination and use of the implants with such devices. Requirements for the safe operation and use of associated instruments and equipment are contained in other standards.

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