Implants for surgery Essential principles of safety and performance

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

01-03-2018

Publisher

International Organization for Standardization

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.

DocumentType	Technical Report
Pages	20
ProductNote	THIS STANDARD ALSO REFERS TO GHTF/AHWG-UDI/N2R3 2011,GHTF/SG1/N044 2008,GHTF/SG1/N055 2009,GHTF/SG1/N68 2012,GHTF/SG1/N70 2011, GHTF/SG1/N71 2012,GHTF/SG1/N78 2012,GHTF/SG5/N1R8 2007,GHTF/SG5/N2R8 2007, GHTF/SG5/N3 2010,
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO/TR 14283:2004

Standards	Relationship
IS/ISO/TR 14283 : 2018	Identical
PD ISO/TR 14283:2018	Identical

ISO 14160:2011	Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 16142-1:2016	Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14630:2012	Non-active surgical implants General requirements
ISO 16061:2015	Instrumentation for use in association with non-active surgical implants General requirements
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices