BS EN ISO 11138-4:2017
$102.76
Sterilization of health care products. Biological indicators – Biological indicators for dry 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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.
NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857 .
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
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 dry heat sterilization |
| 13 | Annex B (normative) Calculation of z value |
| 16 | Bibliography |
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BS EN ISO 11138-4:2017 – TC:2020 Edition
Tracked Changes. Sterilization of health care products. Biological indicators – Biological indicators for dry heat…
