CSA Z314.14 : 2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS
Hardcopy , PDF
19-07-2021
English, French
01-01-2015
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Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions
4 General requirements for all packaging systems
5 Pouches and rolls
6 Wrappers
7 Sterilization trays and container systems
Annex A (informative) - Guidance for the purchase of
sterilization container systems
Annex B (normative) - Information to be supplied by the
manufacturer
Annex C (informative) - Properties of sterilization wrappers
Specifies essential elements for the evaluation, selection, inspection, and proper use of preformed sterile barrier systems, sterile barrier systems, and packaging systems.
| DevelopmentNote |
French Edition issued on 01-01-2016. (02/2016)
|
| DocumentType |
Standard
|
| Pages |
63
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| Supersedes |
| CSA PLUS 1112 : 2004 | INFECTION PREVENTION AND CONTROL IN OFFICE-BASED HEALTH CARE AND ALLIED SERVICES |
| CSA Z314.1:2009 | ETHYLENE OXIDE STERILIZERS FOR HEALTH CARE FACILITIES |
| CSA Z314.3 : 2009 : R2014 | EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS |
| CSA Z314.23 : 2016 | CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS |
| CSA Z314.10.1 : 2015 | SELECTION AND USE OF GOWNS AND DRAPES INTENDED FOR USE IN HEALTH CARE SETTINGS |
| AAMI ST77 : 2013 | CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION |
| ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| CSA Z314.22 : 2016 | MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES |
| CSA Z314.9 : 2009 | INSTALLATION, VENTILATION, AND SAFE USE OF ETHYLENE OXIDE STERILIZERS IN HEALTH CARE FACILITIES |
| CSA Z314.3 : 2009 | EFFECTIVE STERILIZATION IN HEALTH CARE SETTINGS BY THE STEAM PROCESS |
| CSA Z314.10.2 : 2015 | LAUNDERING, MAINTENANCE, AND PREPARATION OF REUSABLE GOWNS, DRAPES, AND WRAPPERS FOR HEALTH CARE SETTINGS AND LAUNDRIES |
| CSA Z8000 : 2011 : R2016 | CANADIAN HEALTH CARE FACILITIES |
| CSA Z8000 : 2011 | CANADIAN HEALTH CARE FACILITIES |
| CSA Z8000 : 2011 : INC : UPD 1 : 2013 | CANADIAN HEALTH CARE FACILITIES |
| CSA Z314.9 : 2009 : R2013 | INSTALLATION, VENTILATION, AND SAFE USE OF ETHYLENE OXIDE STERILIZERS IN HEALTH CARE FACILITIES |
| CSA Z314.2 : 2009 | EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS |
| CSA Z314.1 : 2009 : R2013 | ETHYLENE OXIDE STERILIZERS FOR HEALTH CARE FACILITIES |
| CSA Z314.0 : 2013 | MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS |
| 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 Z314.8 : 2014 | DECONTAMINATION OF REUSABLE MEDICAL DEVICES |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| NFPA 701 : 2015 | FIRE TESTS FOR FLAME PROPAGATION OF TEXTILES AND FILMS |
| CSA Z314.0 : 2013 | MEDICAL DEVICE REPROCESSING - GENERAL REQUIREMENTS |
| DIN 58953-6:2016-12 | Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| CFR 16(PTS1000-END) : 0 | COMMERCIAL PRACTICES - FEDERAL TRADE COMMISSION - CONSUMER PRODUCT SAFETY COMMISSION |
| CSA Z314.22 : 2016 | MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES |
| ASTM F 1608 : 2016 : REDLINE | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| ISO 22610:2006 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment Test method to determine the resistance to wet bacterial penetration |
| EN 13795:2011+A1:2013 | Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels |
| ASTM F 2101 : 2014 : REDLINE | TEST METHOD FOR EVALUATING THE BACTERIAL FILTRATION EFFICIENCY (BFE) OF MEDICAL FACE MASK MATERIALS, USING A BIOLOGICAL AEROSOL OF STAPHYLOCOCCUS AUREUS |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| CGSB 4.162 : M80 | HOSPITAL TEXTILES - FLAMMABILITY PERFORMANCE REQUIREMENTS |
| CSA Z314.23 : 2016 | CHEMICAL STERILIZATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE SETTINGS |
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