EN ISO 11138-3:2017
Current
The latest, up-to-date edition.
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
29-03-2017
European foreword
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 (normative) - Method for determination of
resistance to moist heat sterilization
Annex B (normative) - Calculation of z value and
coefficient of determination, r[2]
Bibliography
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.
| Committee |
CEN/TC 102
|
| DevelopmentNote |
Supersedes EN 866-3 and EN 866-7. (08/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
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