Standard
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AS/NZS 4187:2014
[Current]Specifies the requirements and practices necessary for the effective and safe reprocessing, storage, handling and transportation of reusable medical devices (RMDs) in human health care.
Published: 15/12/2014
Pages: 102
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Introduction
1 Scope and general
2 Quality management
3 Reprocessing agent characterization
4 Process characterization and equipment characterization
5 Product definition
6 Process definition
7 Validation
8 Routine monitoring and control
9 Release of RMDs following reprocessing
10 Maintaining process effectiveness
Appendix A
Appendix B
Amendment control sheets
Cited references in this standard
EN 14180
Sterilizers for Medical Purposes—Low Temperature Steam Formaldehyde Sterilizers—Requirements and Testing
EN 13060
Small Steam Sterilizers
EN 868-10
Packaging For Terminally Sterilized Medical Devices, Part 10: Adhesive Coated Nonwoven Materials Of Polyolefines—Requirements And Test Methods
EN 867-5
Non-biological Systems For Use in Sterilizers, Part 5: Specification For Indicator Systems and Process Challenge Devices For Use in Performance Testing For Small Sterilizers Of Type B and Type S
EN 285
Sterilization—Steam Sterilizers—Large Sterilizers
Content history
[Current]
[Current]
[Superseded]