CSA Z14161 : 2011 : R2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
Hardcopy , PDF
10-08-2020
English
01-01-2015
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Characteristics of biological indicators
6 Selection of supplier
7 Biological indicators in process development
8 Biological indicators in sterilization validation
9 Biological indicators in routine monitoring
10 Results
11 Application of biological indicator standards
12 Culture conditions
13 Third-party requirements
14 Personnel training
15 Storage and handling
16 Disposal of biological indicators
Annex A (informative) - Microbiological inactivation
kinetics and enumeration techniques
Annex B (informative) - Process challenge devices
Annex C (informative) - Formulae for fraction negative
methods for D value calculations
Annex D (informative) - Examples of documentation
for biological indicators prepared by the user
Annex E (informative) - Calculation of z value
Annex F (informative) - D value determination by survivor
curve method
Annex G (informative) - Survival-kill response
characteristics
Bibliography
Annex DA (informative) - A health care professional's
guide to CAN/CSA-Z14161-11, Sterilization of
health care products - Biological indicators -
Guidance for the selection, use and interpretation
of results
Attachment A - D-values
Attachment B - Frequently asked questions about biological
indicators
Specifies guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
| DocumentType |
Standard
|
| Pages |
104
|
| ProductNote |
Reconfirmed EN
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| CSA Z314.7 : 2003(R2018) | STEAM STERILIZERS FOR HEALTH CARE FACILITIES |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| CAN/CSA-ISO 13485:16 | Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01) |
| CSA Z314.2 : 2009 | EFFECTIVE STERILIZATION IN HEALTH CARE FACILITIES BY THE ETHYLENE OXIDE PROCESS |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| AAMI TIR31 : 2008 | PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO/IEC 17011:2004 | Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 9001:2015 | Quality management systems — Requirements |
| CSA ISO 9001 : 2016 | QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/IEC Guide 2:2004 | Standardization and related activities — General vocabulary |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 11138-4:2017 | Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes |
| ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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