NBN EN ISO 11138-3 : 2009
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organisms
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
correlation coefficient, r[2]
Bibliography
ANNEX ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Provides specific 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.
| DevelopmentNote |
Supersedes NBN EN 866-3 and NBN EN 866-7. (04/2007)
|
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| I.S. EN ISO 11138-3:2017 | Identical |
| DIN EN ISO 11138-3:2015-10 (Draft) | Identical |
| EN ISO 11138-3:2017 | Identical |
| UNE-EN ISO 11138-3:2017 | Identical |
| SN EN ISO 11138-3 : 2017 | Identical |
| BS EN ISO 11138-3:2017 | Identical |
| UNI EN ISO 11138-3 : 2009 | Identical |
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