I.S. EN ISO 11138-1:2017
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
Hardcopy , PDF
English
01-01-2017
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National Foreword
European foreword
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.
| DevelopmentNote |
Supersedes I.S. EN 866-1. (09/2006)
|
| DocumentType |
Standard
|
| Pages |
58
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11138-1:2015-10 (Draft) | Identical |
| NBN EN ISO 11138-1 : 2006 | Identical |
| UNE-EN ISO 11138-1:2007 | Identical |
| SN EN ISO 11138-1:2017 | Identical |
| UNI EN ISO 11138-1 : 2006 | Identical |
| EN ISO 11138-1:2017 | Identical |
| NS EN ISO 11138-1 : 2017 | Identical |
| ISO 11138-1:2017 | Identical |
| BS EN ISO 11138-1:2017 | Identical |
| NF EN ISO 11138-1 : 2017 | Identical |
| NEN EN ISO 11138-1 : 2017 | Identical |
| UNE-EN ISO 11138-1:2017 | Identical |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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 11140-1:2014 | Sterilization of health care products Chemical indicators Part 1: General requirements |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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