CSA Z11138-1 : 2007 : R2016
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
Hardcopy , PDF
01-08-2017
English
01-01-2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of resistance
7 Culture conditions
Annex A (normative) - Determination of viable count
Annex B (normative) - Determination of growth inhibition
by carriers and primary packaging materials
exposed to sterilization processes
Annex C (normative) - D value determination by survivor
curve method
Annex D (normative) - D value determination by fraction
negative method
Annex E (normative) - Survival-kill response characteristics
Annex F (informative) - Relationship between components
of biological indicators
Bibliography
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