ISO 11137-2:2013/Amd 1:2022

Overview

ISO 11137-2:2013/Amd 1:2022 is an authoritative international standard focused on the sterilization of health care products using radiation. Specifically, it provides amendments to Part 2 of ISO 11137, which details the procedures for establishing the sterilization dose. This amendment updates guidelines on substantiating sterilization doses, ensuring enhanced accuracy, safety, and efficacy in sterilizing medical devices. Developed by ISO/TC 198 in cooperation with CEN/TC 204, this standard aligns with the Vienna Agreement, reflecting global best practices for radiation sterilization processes.

Key Topics

• Sterilization Dose Establishment
  This standard defines methodologies to determine effective radiation doses that achieve sterility assurance levels (SAL) of 10⁻⁶, critical for patient safety and regulatory compliance.

• Substantiation Methods for Sterilization Doses
  Amendment 1 introduces and references multiple validated methods to substantiate sterilization doses at levels such as 17.5 kGy, 20 kGy, 22.5 kGy, 27.5 kGy, 30 kGy, 32.5 kGy, and 35 kGy:

  • Method VD as described in the forthcoming ISO 13004
  • Method 1 and Method 2 outlined in Clauses 7 and 8 of ISO 11137-2
  • Equivalent methods achieving comparable assurance for an SAL of 10⁻⁶

• Verification Dose Experiment
  The amendment emphasizes conducting verification dose experiments to confirm the suitability of the proposed sterilization dose, incorporating microbial load (bioburden) assessment and validation steps.

• Normative References Update
  The document integrates updates from related amendments to ISO 11137-1, which covers requirements for validation and routine control of sterilization processes, ensuring consistency across the ISO 11137 series.

Applications

• Medical Device Sterilization
  ISO 11137-2:2013/Amd 1:2022 serves manufacturers and sterilization service providers in establishing validated radiation doses tailored to different health care products, ensuring sterility without compromising device integrity.

• Regulatory Compliance
  Compliance with this standard helps meet international regulatory requirements for sterilization validation, aiding market access and conformity assessment.

• Quality Assurance Programs
  It supports quality control by standardizing dose substantiation methods, fostering reproducible and reliable sterilization outcomes in production and routine processing.

• Process Development and Risk Management
  The standard guides the development of radiation sterilization protocols optimized for specific devices, helping to manage sterilization risks related to under- or overexposure.

Related Standards

• ISO 11137-1:2006 with Amendments 1 & 2
  Addresses requirements for development, validation, and routine control of radiation sterilization processes for medical devices, complementing the dose establishment guidance in Part 2.

• ISO 13004 (Under Development)
  Focuses on substantiation of selected sterilization doses using Method VD, providing detailed protocols referenced in this amendment.

• Other Parts of ISO 11137 Series
  The series collectively provides comprehensive coverage of radiation sterilization requirements, applicable to various product types and sterilization methods.

Summary

ISO 11137-2:2013/Amd 1:2022 is essential for professionals involved in the radiation sterilization of medical devices, providing updated, globally harmonized guidance on accurately establishing effective sterilization doses. By adopting this standard, healthcare product manufacturers and sterilization experts can ensure superior sterility assurance, enhance patient safety, and streamline regulatory compliance. For more detailed information and implementation support, users should consult the full ISO 11137 series and related standards on the ISO website.