BS EN ISO 11138-3:2017
$102.76
Sterilization of health care products. Biological indicators – Biological indicators for moist heat sterilization processes
| Published By | Publication Date | Number of Pages |
| BSI | 2017 | 20 |
This document 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | European foreword Endorsement notice |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 5 Test organism |
| 10 | 6 Suspension 7 Carrier and primary packaging 8 Inoculated carriers and biological indicators 9 Population and resistance |
| 12 | Annex A (normative) Method for determination of resistance to moist heat sterilization |
| 13 | Annex B (normative) Calculation of z value and coefficient of determination, r2 |
| 16 | Bibliography |
