CSA Z1416: 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
10-08-2020
English
01-01-2015
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
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