UNE-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
Spanish, Castilian, English
08-11-2017
1.1General1.1.1This part of ISO 11138 provides 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.1.1.2This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.NOTENational or regional regulations may apply.
| Committee |
CTN 111
|
| DevelopmentNote |
Supersedes UNE EN 866-1. (05/2007)
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| 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 |
| NBN EN ISO 11138-1 : 2006 | Identical |
| EN ISO 11138-1:2017 | Identical |
| I.S. EN ISO 11138-1:2017 | Identical |
| NEN EN ISO 11138-1 : 2017 | Identical |
| DIN EN ISO 11138-1:2015-10 (Draft) | 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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