Overview
EN ISO 11137-2:2015 (ISO 11137-2:2013) - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - specifies methods for determining the minimum radiation dose required to achieve a defined sterility assurance level (SAL). The standard addresses dose-setting and dose-substantiation approaches, including methods to justify the use of 25 kGy or 15 kGy as the sterilization dose to achieve an SAL of 10−6, and defines procedures for ongoing sterilization dose audit to confirm continued effectiveness.
Key Topics
- Sterilization dose determination: Methods to establish the minimum effective radiation dose required to meet a specified SAL for a product or product family.
- Dose substantiation for 25 kGy and 15 kGy: Procedures to demonstrate that a routine dose of 25 kGy or 15 kGy achieves the targeted SAL 10−6 for the product.
- Sterilization dose audit: Audit methodologies for periodic verification that the selected sterilization dose remains effective during routine processing.
- Product family concept: Definition, grouping and maintenance of product families for dose setting and dose audit to allow representative testing across similar products.
- Selection and testing of representative products: Criteria for choosing a product that represents a family for verification dose experiments and audits.
- Regulatory alignment: Informative annexes linking the standard to EU directives (medical devices, active implantable devices, in vitro diagnostics), supporting conformity assessment.
Applications and Who Uses It
EN ISO 11137-2:2015 is used by:
- Medical device manufacturers validating radiation sterilization for single products or product families.
- Contract sterilization facilities implementing dose-setting and periodic dose audits.
- Quality assurance and regulatory affairs teams preparing technical documentation and conformity evidence.
- Validation engineers and microbiologists designing verification dose experiments and monitoring sterilization performance.
Practical uses:
- Establishing a validated radiation sterilization process that meets accepted SAL 10−6 criteria.
- Substantiating industry-standard doses (25 kGy / 15 kGy) to reduce need for extensive dose-setting when appropriate.
- Conducting routine dose audits to ensure ongoing sterilization efficacy and regulatory compliance.
Related Standards
- EN ISO 11137-1 - Requirements for development, validation and routine control of a sterilization process using radiation.
- ISO 11737-1 / ISO 11737-2 - Microbiological methods relevant to bioburden and confirmation of sterilization.
- Relevant EU Directives referenced in annexes (for medical device conformity).
Benefits of following EN ISO 11137-2:2015 include robust sterilization dose justification, streamlined validation for product families, and stronger evidence for regulatory submissions involving radiation sterilization.