The ISO standard for sterility testing is not directly specified by a single ISO number within the provided reference. However, ISO 11737-2 is relevant because it covers aspects of sterility testing. Specifically, it focuses on the initial determination of a product's bioburden to inform the sterility testing process. This involves method validation and ensuring the suitability of culture mediums for detecting aerobic and anaerobic bacteria and fungi.
Key Aspects Covered by ISO 11737-2 Relevant to Sterility Testing:
- Method Validation: Ensuring the testing method is reliable. According to ISO 11737-2, method validation includes determining the initial bacterial count of control suspensions.
- Culture Medium Suitability: Verifying that the culture mediums used can support the growth of potential contaminants, including aerobic and anaerobic bacteria and fungi.
- Product Suitability: Assessing whether the test method is appropriate for the specific product being tested.
Interpreting the Question
While the question asks for the ISO for sterility testing, it's important to understand that sterility testing often involves a suite of standards and guidelines, and there isn't one single "ISO for sterility testing". ISO 11737-2 is one relevant standard that addresses an important part of that overall testing. Other relevant ISO standards could relate to specific types of products, methods of sterilization, or general quality management systems that encompass sterility assurance.
