I.S. EN ISO 11138-4:2017
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017)
Hardcopy , PDF
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
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.
| DevelopmentNote |
Supersedes I.S. EN 866-6. (09/2006)
|
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN 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 |
| UNI EN ISO 11138-4 : 2006 | Identical |
| UNE-EN ISO 11138-4:2017 | Identical |
| NEN EN ISO 11138-4 : 2017 | Identical |
| DIN EN ISO 11138-4:2015-10 (Draft) | Identical |
| EN ISO 11138-4:2017 | Identical |
| ISO 11138-4:2017 | Identical |
| NF EN ISO 11138-4 : 2017 | Identical |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
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