CSA Z314.3 : 2009 : R2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS
Hardcopy , PDF
09-10-2020
English, French
01-01-2014
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Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions
4 Utilities
5 Preparing medical devices and packages for steam sterilization
6 Packaging
7 Sterilizer loading and operation
8 Sterility assurance
9 Immediate use steam sterilization (IUSS)
Annex A (informative) - Examples for performance qualification of
products and loads
Annex B (informative) - Tools and indicators for sterilization
monitoring
Annex C (informative) - Specifications and calculations for the
density of muslin textile packages
Annex D (informative) - Steam quality
Annex E (informative) - In-house prepared PCDs
Annex F (informative) - Moisture assessment
Annex G (informative) - Relevant standards
Defines essential elements for using steam to sterilize medical devices in health care settings, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care setting personnel and patients.
| DevelopmentNote |
Supersedes and renumbers CSA CAN3 Z314.3. (07/2004) Supersedes CSA Z314.13. (05/2010) To be read in conjunction with CSA Z314.0. (09/2014) French Edition issued on 01-03-2015. (05/2015)
|
| DocumentType |
Standard
|
| Pages |
130
|
| ProductNote |
Reconfirmed EN
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| 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 |
| ISO/TS 17665-3:2013 | Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
| 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 Z314.8 : 2014 | DECONTAMINATION OF REUSABLE MEDICAL DEVICES |
| BS EN 285:2015 | Sterilization. Steam sterilizers. Large sterilizers |
| AAMI TIR34 : 2014 | WATER FOR THE REPROCESSING OF MEDICAL DEVICES |
| CSA Z314.7 : 2003(R2018) | STEAM STERILIZERS FOR HEALTH CARE FACILITIES |
| CSA Z314.0 : 2013 | MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS |
| CSA Z314.14 : 2015 | SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS |
| AAMI TIR31 : 2008 | PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES |
| 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 |
| ISO 11140-5:2007 | Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
| ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| CSA Z32 : 2015 | ELECTRICAL SAFETY AND ESSENTIAL ELECTRICAL SYSTEMS IN HEALTH CARE FACILITIES |
| ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| CSA Z314.23 : 2016 | CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS |
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