ISO 11138-1:2006
Sterilization of health care products - Biological indicators - Part 1: General requirements
- Standard No.
- ISO 11138-1:2006
- Release Date
- 2006
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 11138-1:2017
- Latest
- ISO 11138-1:2017
- Scope
- 1.1 General 1.1.1 This 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. 1.1.2 This 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. NOTE National or regional regulations may apply. 1.2 Exclusions This part of ISO 11138 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 part of ISO 11138, however, could contain elements relevant to such microbiological test systems.
ISO 11138-1:2006 Referenced Document
- ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
- ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
- ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
- ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*， 2017-06-01 Update
- ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
ISO 11138-1:2006 history
- 2017 ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
- 2006 ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
- 1994 ISO 11138-1:1994 Sterilization of health care products - Biological indicators - Part 1: General
