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AS ISO 11137-2002

AS ISO 11137-2002

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

06-30-2017

Superseded by

AS/NZS ISO 11137.3:2006
AS/NZS ISO 11137.1:2006
AS/NZS ISO 11137.2:2006

Language(s)

English

Published date

01-01-2002

Publisher

Standards Australia

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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1 - AS ISO 11137-2002 Sterilization of health care products - Requirements for validation and routine control - Radiation ster
4 - PREFACE
5 - CONTENTS
7 - INTRODUCTION
9 - 1 SCOPE
9 - 2 NORMATIVE REFERENCES
9 - 3 DEFINITIONS
12 - 4 DOCUMENTATION
12 - 5 PERSONNEL
12 - 6 STERILIZATION PROCESS VALIDATION
16 - 7 ROUTINE PROCESS CONTROL
19 - 8 MANAGEMENT AND CONTROL
20 - ANNEX A DEVICE AND PACKAGING MATERIALS QUALIICICATION
25 - ANNEX B DOSE SETTING METHODS FOR RADIATION STERILIZATION
54 - ANNEX C DOSIMETERS, DOSIMETRY AND ASSOCIATED EQUIPMENT
67 - ANNEX D BIBILOGRAPHY

Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products.

Committee
HE-023
DocumentType
Standard
ISBN
0 7337 4705 1
Pages
61
PublisherName
Standards Australia
Status
Superseded
SupersededBy
Supersedes
UnderRevision

Standards Relationship
ISO 11137:1995 Identical

First published as AS ISO 11137-2002.

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