Table of Contents

Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions
4 General requirements
5 Quality management system (QMS)
6 Personnel
7 Manufacturer's instructions for use (MIFUs)
8 Evaluation and purchase of reusable medical devices,
   reprocessing equipment, sterile barrier systems,
   and consumables
9 Loaned, reusable medical devices
10 Work areas and design
11 Decontamination of reusable medical devices
12 Flexible endoscopes
13 Ultrasound transducer probes
14 Preparation of medical devices for reprocessing
15 Selection and use of sterile barrier systems
16 Sterilization methods
17 Storage, transportation, and distribution of single-use
   and reusable medical devices
18 Equipment maintenance and quality assurance
19 Selection and use of gowns and drapes
20 Laundering, maintenance, and preparation of reusable
   gowns, drapes, and wrappers
Annex A (informative) - Applying CAN/CSA-ISO 9001 QMS
        requirements to medical device reprocessing
Annex B (informative) - Risk management and sterility
        assurance
Annex C (informative) - Sample forms and tools for MDRDs
Annex D (informative) - Donning and doffing of PPE
Annex E (normative) - Information to be supplied by the
        sterilization container manufacturer
Annex F (informative) - Guidance for the design of medical
        device reprocessing areas
Annex G (informative) - Water quality
Annex H (informative) - Steam quality
Annex I (informative) - Indicators for sterilization monitoring
Annex J (informative) - Examples for performance qualification
        of products and loads
Annex K (informative) - Guidance on selection of gowns
Annex L (informative) - Moisture assessment
Annex M (informative) - Suggested methods for preparing and
        folding packs, gowns, and drapes
Annex N (informative) - Guidance for the purchase of
        sterilization container systems
Annex O (informative) - Properties of sterilization wrappers
Annex P (informative) - Specifications and calculations for
        the density of reusable textile packages
Annex Q (informative) - High relative humidity in sterile
        storage areas
Annex R (informative) - Guidance on storage and handling
Annex S (informative) - Guidance on selection of an automated
        storage system
Annex T (informative) - Evaluation criteria for laundries
Annex U (informative) - Guidance for the design of laundering
        and laundry areas

Abstract

Pertains to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN