Implants for surgery. Minimum data sets for surgical implants

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

17-07-2019

Publisher

British Standards Institution

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems.

This document defines minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry.

This document is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures. It specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event.

This document is intended to define a minimum data set to be recorded for all implant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial codes, for the purpose of patient follow up.

It is not the intent of this document to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up or product recall in the event of unforeseen device malfunction.

Committee	CH/150
DocumentType	Standard
ISBN	9780580920554
Pages	16
ProductNote	THIS STANDARD IS IDENTICAL TO- ISO 16054 THIS STANDARD ALSO REFERS TO- ANSI/HIBC 2.5:2015
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 16054:2002

Standards	Relationship
EN ISO 16054:2019	Identical

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BS EN ISO 16054:2019

Implants for surgery. Minimum data sets for surgical implants

Abstract

Scope

General Product Information

International Equivalents

Category

Subcategory