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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS
Hardcopy , PDF
09-23-2021
English, French
01-01-2013
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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
Pertains to form the basis of a QMS within a health care setting for the purpose of providing safe, reliable reprocessing of reusable medical devices and is designed to be used with the CSA Z314 series of Standards addressing specific aspects of medical device reprocessing.
| DevelopmentNote |
French Edition issued on 01-11-2014. (12/2014)
|
| DocumentType |
Standard
|
| Pages |
153
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy |
| CSA Z11135 : 2015 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| CSA Z314.3 : 2009 : R2014 | EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS |
| CSA Z314.8 : 2014 | DECONTAMINATION OF REUSABLE MEDICAL DEVICES |
| CSA Z314.23 : 2016 | CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS |
| CSA Z314.14 : 2015 | SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS |
| CSA Z314.10.1 : 2015 | SELECTION AND USE OF GOWNS AND DRAPES INTENDED FOR USE IN HEALTH CARE SETTINGS |
| CSA Z314.22 : 2016 | MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES |
| CSA Z314.3 : 2009 | EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS |
| CSA Z314.15 : 2015 | STORAGE, TRANSPORTATION, AND DISTRIBUTION OF SINGLE USE AND REUSABLE MEDICAL DEVICES |
| CSA Z314.10.2 : 2015 | LAUNDERING, MAINTENANCE, AND PREPARATION OF REUSABLE GOWNS, DRAPES, AND WRAPPERS FOR HEALTH CARE SETTINGS AND LAUNDRIES |
| CSA SPE 1112 : 2014 | MEDICAL DEVICE REPROCESSING IN COMMUNITY HEALTH CARE SETTINGS |
| CSA Z317.2 : 2010 | SPECIAL REQUIREMENTS FOR HEATING, VENTILATION, AND AIR-CONDITIONING (HVAC) SYSTEMS IN HEALTH CARE FACILITIES |
| CSA Z314.10.1 : 2015 | SELECTION AND USE OF GOWNS AND DRAPES INTENDED FOR USE IN HEALTH CARE SETTINGS |
| CSA Z314.10.2 : 2015 | LAUNDERING, MAINTENANCE, AND PREPARATION OF REUSABLE GOWNS, DRAPES, AND WRAPPERS FOR HEALTH CARE SETTINGS AND LAUNDRIES |
| CSA Z317.2 : 2010 | SPECIAL REQUIREMENTS FOR HEATING, VENTILATION, AND AIR-CONDITIONING (HVAC) SYSTEMS IN HEALTH CARE FACILITIES |
| CSA Z314.8 : 2014 | DECONTAMINATION OF REUSABLE MEDICAL DEVICES |
| AAMI TIR34 : 2014 | WATER FOR THE REPROCESSING OF MEDICAL DEVICES |
| CSA Z314.7 : 2003(R2018) | STEAM STERILIZERS FOR HEALTH CARE FACILITIES |
| CAN/CSA-ISO 13485:16 | Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01) |
| CSA Z314.14 : 2015 | SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS |
| CSA Z314.22 : 2016 | MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES |
| CSA Z314.15 : 2015 | STORAGE, TRANSPORTATION, AND DISTRIBUTION OF SINGLE USE AND REUSABLE MEDICAL DEVICES |
| CSA ISO 9001 : 2016 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS |
| ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| CSA Z314.23 : 2016 | CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS |
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