I.S. EN ISO 11138-5:2017
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017)
Hardcopy , PDF
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
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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 low-temperature steam and
formaldehyde
Annex B (informative) - Rationale for the liquid-phase
test method for low-temperature steam and
formaldehyde biological indicators
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 low-temperature steam and formaldehyde as the sterilizing agent.
| DevelopmentNote |
Supersedes I.S. EN 866-5. (09/2006)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 11138-5:2017 | Identical |
| NEN EN ISO 11138-5 : 2017 | Identical |
| UNI EN ISO 11138-5 : 2006 | Identical |
| NS EN ISO 11138-5 : 2017 | Identical |
| SN EN ISO 11138-5 : 2017 | Identical |
| DIN EN ISO 11138-5:2015-10 (Draft) | Identical |
| NBN EN ISO 11138-5 : 2006 | Identical |
| ISO 11138-5:2017 | Identical |
| BS EN ISO 11138-5:2017 | Identical |
| UNE-EN ISO 11138-5:2017 | Identical |
| NF EN ISO 11138-5 : 2017 | Identical |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 25424:2009 | Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| 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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