ISO 11137-1:2006/Amd 2:2018

Overview

ISO 11137-1:2006/Amd 2:2018 is an important amendment to the international standard for the sterilization of healthcare products using radiation. This document focuses on requirements for the development, validation, and routine control of radiation sterilization processes for medical devices. It specifically revises sections 4.3.4 and 11.2 of the original ISO 11137-1:2006 to improve clarity and provide additional guidance on dosimetry and operational procedures.

Developed by ISO Technical Committee ISO/TC 198, which specializes in sterilization of healthcare products, this amendment underlines the critical role of radiation sterilization in ensuring the safety and effectiveness of medical devices before they reach patients.

Key Topics

• Development and Validation Requirements
  The standard outlines the framework for creating reliable sterilization processes, including the validation steps necessary to confirm that radiation sterilization consistently achieves the required sterility assurance levels.

• Routine Control Procedures
  It mandates regular monitoring and controls to maintain sterilization efficacy during ongoing production, minimizing risk and maintaining compliance.

• Dosimetry and Measurement Uncertainty (Section 4.3.4 Amendment)
  This amendment adds recommendations for dosimetry practices-critical for accurately measuring radiation doses applied-and highlights the importance of understanding associated measurement uncertainty. Reference is made to ISO 11137-3 for detailed guidance on dosimetric procedures.

• Operational Requirements (Section 11.2 Amendment)
  Revised wording clarifies that operational procedures must specify the necessary criteria (referencing Clauses 9.4.3 or 9.4.4) that a sterilization process must meet to be deemed compliant.

Applications

ISO 11137-1:2006/Amd 2:2018 is invaluable for manufacturers, quality assurance professionals, and regulatory bodies involved with:

• Medical Device Manufacturing
  Ensuring that sterilization processes comply with internationally recognized standards to guarantee product sterility and patient safety.

• Radiation Sterilization Facilities
  Implementing and controlling validated radiation processes for a range of healthcare products, helping maintain consistent sterilization performance.

• Quality Management Systems
  Supporting traceability and record-keeping to meet regulatory and industry requirements focused on the validation and routine control of sterilization.

• Risk Management
  Assisting in the identification and mitigation of risks related to sterilization failure, thereby enhancing device safety.

Related Standards

• ISO 11137 Series
  This amendment is part of the ISO 11137 series, which collectively addresses the comprehensive sterilization process using radiation, including:

  • ISO 11137-2: Requirements for establishing the sterilization dose.
  • ISO 11137-3: Guidance on dosimetric aspects, including measurement uncertainty and calibration techniques.

• ISO 13485
  Quality management systems for medical devices, which often reference sterilization standards for product safety compliance.

• ISO/IEC Directives
  Framework for development and updating of ISO standards, ensuring consistency and procedural integrity.

This amendment to ISO 11137-1 reinforces best practices in radiation sterilization of medical devices, providing essential clarifications to improve dosimetry accuracy and operational compliance. Organizations implementing this standard help safeguard healthcare product sterility, enhance patient safety, and maintain regulatory conformance in the highly regulated medical device industry.