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CSA Z314.2 : 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS

Available format(s)

Hardcopy , PDF

Superseded date

01-03-2012

Language(s)

English, French

Published date

01-01-2009

Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions
4 General requirements
   4.1 General
   4.2 Policy
   4.3 Procedures
   4.4 Manufacturer's instructions
   4.5 Quality system
   4.6 Documentation and records
   4.7 Ethylene oxide safety
   4.8 Alerts
5 Evaluation and purchase of reusable medical devices and
   sterilization supplies
   5.1 General
   5.2 Manufacturer's instructions
   5.3 Packaging materials
   5.4 Sterilization indicators and PCDs
6 Personnel
   6.1 General
   6.2 Qualifications
   6.3 Orientation, training, and continuing education
   6.4 Competency assessment
   6.5 Immunization
   6.6 Routine infection prevention and control practices
   6.7 Attire
   6.8 Ethylene oxide leaks
7 Work areas and equipment
   7.1 Area design
   7.2 Sterile storage area
   7.3 Traffic control
   7.4 Environmental controls
   7.5 Area cleaning
   7.6 Sterilization equipment
8 Preparation
   8.1 General
   8.2 Decontamination
   8.3 Lubrication
   8.4 Preparations to ensure sterilant contact with all
       surfaces
9 Packaging
   9.1 General
   9.2 Wrapping materials
   9.3 Sterilization pouches
   9.4 Rigid sterilization containers
   9.5 Packaging methods
10 Sterilizer loading and operation loading
   10.1 Loading
   10.2 Sterilizer operation
   10.3 Aeration
   10.4 Opening of sterilizer door at cycle completion
   10.5 Sterilizer unloading
   10.6 Dust covers
   10.7 Safe handling, storage, and disposal of ethylene oxide
        cylinders and cartridges
11 Storage
   11.1 General
   11.2 Storage area
   11.3 Inventory management
   11.4 Distribution
12 Sterility assurance
   12.1 General
   12.2 Tools and indicators for monitoring
   12.3 Installation qualification
   12.4 Operational qualification and requalification
   12.5 Performance qualification
   12.6 Routine monitoring
   12.7 Documenting sterility assurance procedures and
         test results
   12.8 Interpretation and response to failed chemical
         indicators
   12.9 Interpretation and response to failed biological
         indicators
   12.10 Recalls
   12.11 In-house prepared PCDs
13 Maintenance and sterilizer quality assurance
Annexes
A (informative) - Sample job descriptions
B (informative) - Guidance for the design of medical device
  reprocessing areas
C (Informative) - High relative humidity in sterile storage
  areas
D (informative) - Risk management and sterility assurance
E (informative) - Additional guidance on sterilization
  indicators and PCDs
F (informative) - Relevant Standards

Describes essential elements in implementing a program for using ethylene oxide to sterilize medical devices in health care facilities, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care facility personnel and patients.

DevelopmentNote
Supersedes and renumbers CSA CAN3 Z314.2 (07/2004) French Edition issued on 01-12-2009. (05/2010)
DocumentType
Standard
Pages
130
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

CSA Z441 : 1988 TERMINOLOGY AND DEFINITIONS USED IN CSA HEALTH CARE TECHNOLOGY STANDARDS
CSA PLUS 1112 : 2004 INFECTION PREVENTION AND CONTROL IN OFFICE-BASED HEALTH CARE AND ALLIED SERVICES
CSA Z1416: 2011 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
CSA Z11135-1 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z314.1:2009 ETHYLENE OXIDE STERILIZERS FOR HEALTH CARE FACILITIES
CSA Z11135-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z14161 : 2011 : R2015 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
AAMI TIR31 : 2008 PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES
CSA Z314.9 : 2009 INSTALLATION, VENTILATION, AND SAFE USE OF ETHYLENE OXIDE STERILIZERS IN HEALTH CARE FACILITIES
CSA Z11135-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CSA Z8000 : 2011 CANADIAN HEALTH CARE FACILITIES
CSA Z8000 : 2011 : R2016 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 Z314.1 : 2009 : R2013 ETHYLENE OXIDE STERILIZERS FOR HEALTH CARE FACILITIES
CSA Z314.10 : 2003 SELECTION, USE, MAINTENANCE AND LAUNDERING OF REUSABLE TEXTILE WRAPPERS, SURGICAL GOWNS AND DRAPES FOR HEALTH FACILITIES

AAMI ST35 : 3ED 2003 SAFE HANDLING AND BIOLOGICAL DECONTAMINATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE FACILITIES AND IN NONCLINICAL 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
AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
CAN/CSA-Z317.13-17 Infection control during construction, renovation, and maintenance of health care facilities
CSA Z314.14 : 2015 SELECTION AND USE OF PACKAGING (STERILE BARRIER SYSTEMS) IN HEALTHCARE SETTINGS
CSA Z314.13 : 2001 RECOMMENDED STANDARD PRACTICES FOR EMERGENCY (FLASH) STERILIZATION
AAMI ST46 : 4ED 2002 STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
NFPA 560 : 2007 STORAGE, HANDLING, AND USE OF ETHYLENE OXIDE FOR STERILIZATION AND FUMIGATION
CSA Z314.22 : 2016 MANAGEMENT OF LOANED, REUSABLE MEDICAL DEVICES
CSA Z314.10 : 2003 SELECTION, USE, MAINTENANCE AND LAUNDERING OF REUSABLE TEXTILE WRAPPERS, SURGICAL GOWNS AND DRAPES FOR HEALTH FACILITIES
CSA Z314.15 : 2015 STORAGE, TRANSPORTATION, AND DISTRIBUTION OF SINGLE USE AND REUSABLE MEDICAL DEVICES
NFPA 30 : 2018 FLAMMABLE AND COMBUSTIBLE LIQUIDS CODE
ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
CSA PLUS 1112 : 2004 INFECTION PREVENTION AND CONTROL IN OFFICE-BASED HEALTH CARE AND ALLIED SERVICES
Z317.5-17 Illumination design in health care facilities

$243.08
Including GST where applicable

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