EN ISO 11138-4:2017
Current
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
03-29-2017
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 dry heat sterilization
Annex B (normative) - Calculation of z value
Bibliography
Describes 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 degrees C to 180 degrees C.
| Committee |
CEN/TC 102
|
| DevelopmentNote |
Supersedes EN 866-6. (07/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| PN EN ISO 11138-4 : 2017 | Identical |
| BS EN ISO 11138-4:2017 | Identical |
| NBN EN ISO 11138-4 : 2006 | Identical |
| NS EN ISO 11138-4 : 2017 | Identical |
| NEN EN ISO 11138-4 : 2017 | Identical |
| I.S. EN ISO 11138-4:2017 | Identical |
| DIN EN ISO 11138-4:2015-10 (Draft) | Identical |
| DIN EN ISO 11138-4:2017-07 | Identical |
| SS-EN ISO 11138-4 : 2017 | Identical |
| ISO 11138-4:2017 | Identical |
| NF EN ISO 11138-4 : 2017 | Identical |
| UNE-EN ISO 11138-4:2017 | Identical |