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ISO/TR 14283:2018

Implants for surgery -- Essential principles of safety and performance

General information

Valid from 03.01.2018
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.01.2018
Main
ISO/TR 14283:2018
Main
ISO/TR 14283:2004
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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Standard monitoring
English (PDF 264 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English