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AS/NZS 4187:2014

[Current]

Reprocessing of reusable medical devices in health service organisations

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

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