CSA Z314.0 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS
Hardcopy , PDF
09-23-2021
English, French
01-01-2013
Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions
4 Quality management system (QMS)
5 Evaluation and purchase of reusable medical devices
and reprocessing equipment
6 Personnel
7 Work areas and design
8 Reprocessing principles
9 Process verification, monitoring, and adverse events
10 Storage
Annex A (informative) - Micro-organisms and infection
Annex B (informative) - Guidance for the design of medical
device reprocessing areas
Annex C (informative) - Additional sterile storage
considerations
Annex D (informative) - Risk management and sterility
assurance
Annex E (informative) - Water quality
Annex F (informative) - Sample forms and tools for MDRDs
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