Retrieval and analysis of surgical implants Retrieval and handling

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

06-30-2015

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Method
4 Analysis of retrieved surrounding tissues and fluids
5 Infection control
Annex A (informative) - Suggested minimum information to
        be obtained for retrieved surgical implants
Annex B (informative) - Generic procedures for the
        decontamination of surgical implants
Annex C (informative) - Analyses to be performed on
        retrieved tissue samples and fluids
Bibliography

Defines the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. Also define the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping.

This part of ISO 12891 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. This part of ISO 12891 also provides guidance on infection control.

NOTE National or other regulations, which can be more stringent, can apply.

This part of ISO 12891 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.

Committee	CH/150
DevelopmentNote	Supersedes 10/30195943 DC. (05/2011)
DocumentType	Standard
Pages	36
PublisherName	British Standards Institution
Status	Current
Supersedes	BS ISO 12891-1:2011 10/30195943 DC : 0

Standards	Relationship
ISO 12891-1:2015	Identical

ASTM F 561 : 2013	Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
NSF 49 : 2016	BIOSAFETY CABINETRY: DESIGN, CONSTRUCTION, PERFORMANCE, AND FIELD CERTIFICATION
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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BS ISO 12891-1:2015

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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