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CSA Z314.0 : 2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

09-23-2021

Language(s)

English, French

Published date

01-01-2013

Publisher

Canadian Standards Association

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Superseded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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Hardcopy - English
PDF - English
Hardcopy - French
PDF - French
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