BS EN ISO 11138-1:2017
Current
The latest, up-to-date edition.
Sterilization of health care products. Biological indicators General requirements
Hardcopy , PDF
English
30-04-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of population and resistance
7 Culture conditions
Annex A (normative) - Determination of viable count
Annex B (normative) - Determination of growth
inhibition by carriers and primary packaging
materials exposed to sterilization processes
Annex C (normative) - D value determination by
survivor curve method
Annex D (normative) - D value determination by
fraction negative method
Annex E (normative) - Survival-kill response
characteristics
Annex F (informative) - Relationship between
components of biological indicators
Bibliography
Describes general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes BS EN 866-1 and 04/30078095 DC (08/2006) Supersedes 15/30321502 DC. (04/2017)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
This document specifies basic and common requirements that are applicable to all parts of ISO11138 . Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO11138 . If no specific subsequent part is provided, this document applies.
NOTE National or regional regulations can apply.
This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
| Standards | Relationship |
| DIN EN ISO 11138-1:2015-10 (Draft) | Identical |
| NBN EN ISO 11138-1 : 2006 | Identical |
| EN ISO 11138-1:2017 | Identical |
| NS EN ISO 11138-1 : 2017 | Identical |
| ISO 11138-1:2017 | Identical |
| NF EN ISO 11138-1 : 2017 | Identical |
| I.S. EN ISO 11138-1:2017 | Identical |
| NEN EN ISO 11138-1 : 2017 | Identical |
| DIN EN ISO 11138-1:2017-07 | Equivalent |
| UNE-EN ISO 11138-1:2017 | Identical |
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