Glossary Term
ISO 11737 (Sterilization of Medical Devices – Microbiological Methods)
Definition
ISO 11737 is an international standard that outlines requirements and methodologies for assessing microbiological contamination in medical devices. It consists of two parts: the determination of bioburden (ISO 11737-1) and sterilization process validation using biological indicators (ISO 11737-2). These standards ensure that sterilization processes achieve the desired Sterility Assurance Level (SAL) while maintaining patient safety.
Relevance to the MedTech Industry
ISO 11737 ensures the reliability and safety of sterilization processes by providing validated methods to measure and monitor microbial contamination on medical devices. This standard supports manufacturers in demonstrating compliance with sterility requirements for regulatory approval and maintaining consistent product quality.
Additional Information & Related Terms
Key Sections of ISO 11737
ISO 11737-1: Bioburden Testing
Provides methods for determining the number and types of microorganisms on medical devices before sterilization.
Includes guidelines for sample preparation, microbial enumeration, and bioburden recovery efficiency.
ISO 11737-2: Sterilization Validation Using Biological Indicators
Outlines the use of biological indicators (BIs) to validate and monitor sterilization processes.
Specifies protocols for placing, retrieving, and analyzing BIs to ensure sterilization efficacy.
Related Terms
Bioburden Testing: The measurement of microbial load on a device before sterilization, as outlined in ISO 11737-1.
Biological Indicator (BI): A test system containing viable microorganisms used in sterilization validation under ISO 11737-2.
Sterility Assurance Level (SAL): The probability of a single viable microorganism surviving the sterilization process, typically set at 10⁻⁶ for medical devices.
ISO 11137: A related standard for radiation sterilization that often requires ISO 11737 compliance for microbiological testing.