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ISO/TR 14283:2018

Implants for surgery — Essential principles of safety and performance

Standard Details

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 StandardDetails.

General Information

Status : Published
Standard Type: Main
Document No: ISO/TR 14283:2018
Document Year: 2018
Pages: 20
Edition: 3
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

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ISO/TR 14283:2018
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