What is ISO 11138-7 –Guidance for biological indicators in sterilization of health care products about?
ISO 11138 is an international standard that discusses biological indicators for sterilization of health care products. ISO 11138-7 provides the best industry guidance for the selection, use, and interpretation of results from the application of biological indicators when used in the development, validation, and routine monitoring of sterilization processes to ensure the safety of healthcare products.
ISO 11138-7 is the seventh part of a multi-part series that guides on the selection of the correct biological indicator for their sterilization process critical parameters as well as guidance on its appropriate use.
Note 1: ISO 11138-7 does not apply to the combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.
Note 2: ISO 11138-7 does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration.
Note 3: ISO 11138-7 does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room bio-decontamination processes at atmospheric pressure.
Note 4: ISO 11138-7 does not apply to liquid immersion sterilization processes.
Who is ISO 11138-7-Guidance for biological indicators in sterilization of health care products for?
ISO 11138-7 on the guidance for biological indicators in sterilization of health care products is relevant to:
- Health care products manufacturers
- Biological indicator test runners
Why should you use ISO 11138-7 - Guidance for biological indicators in sterilization of health care products?
The performance of a biological indicator can be adversely affected by the conditions of storage and transport before its use, by inappropriate/non-indicated use of the biological indicator or by the sterilizer process parameters. Biological indicators are utilized to test the effectiveness of a given sterilization process and the equipment used, by assessing microbial lethality according to the concept of sterility assurance level.
ISO 11138-7 guideline assists you with characteristics of biological indicators, selection of supplier, biological indicators in process development, biological indicators in sterilization validation, biological indicators in routine monitoring, interpretation criteria, acceptance criteria, application of biological indicator standards, culture conditions, third-party considerations, disposal of biological indicators, storage, and handling for the selection, use, and interpretation of results for biological indicators.
This assists in selecting proper biological indicators that can help in the sterilization of health care products and when wrapping products. In addition, with compliance and obedience to ISO 11138-7, you can ensure the safety of health care products.
