ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series. NOTE 2 National or regional regulations can provide requirements for work place safety.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A Method for determination of resistance to moist heat sterilization (normative)
Annex B Calculation of z value and coefficient of determination, r2 (normative)
ISO 11138-1:2017 Sterilization of health care products -- Biological indicators -- Part 1: General requirements
ISO 18472:2006 Sterilization of health care products -- Biological and chemical indicators -- Test equipment
ISO 11138-1:2017 Sterilization of health care products -- Biological indicators -- Part 1: General requirements
ISO 18472:2006 Sterilization of health care products -- Biological and chemical indicators -- Test equipment