What is ISO 11137 All About?
ISO 11137 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the sterilization of medical devices using radiation. The standard is intended to be used in conjunction with other ISO standards, such as ISO 10993, which covers the evaluation of biocompatibility of medical devices, and ISO 13485, which covers the quality management systems for medical devices.
The standard covers the requirements for the development, validation, and routine control of a radiation sterilization process for medical devices. The standard applies to the sterilization of medical devices using ionizing radiation, specifically gamma radiation and electron-beam radiation. It covers the requirements for both industrial and hospital-based sterilization processes and applies to both single-dose and multi-dose devices.
The standard is divided into several sections that cover different aspects of the radiation sterilization process. The sections include:
Scope and Normative References: This section provides an overview of the scope of the standard and the other standards that are related to it.
Terms and Definitions: This section defines the terms and concepts that are used in the standard.
Requirements for Development, Validation and Routine Control: This section covers the requirements for the development, validation, and routine control of the radiation sterilization process. It includes requirements for the selection and characterization of the sterilization dose and dose distribution, the design and validation of the sterilization process, the use of appropriate radiation monitoring equipment, and the implementation of a quality management system.
Product and Process Control: This section covers the requirements for product and process control to ensure continued effective sterilization throughout the product lifecycle. It includes requirements for the bioburden, dose audits, and routine dose monitoring.
Sterilization Information: This section covers the requirements for the provision of appropriate documentation and records. It includes requirements for the sterilization information to be provided with the medical device and the records that must be kept by the manufacturer.
Labeling: This section covers the requirements for the labeling of medical devices that have been sterilized using radiation.
Packaging: This section covers the requirements for the packaging of medical devices that have been sterilized using radiation.
ISO 11137 is an important standard for manufacturers of medical devices that use radiation sterilization. The standard provides guidelines for the development, validation, and routine control of the sterilization process to ensure that medical devices are properly sterilized to minimize the risk of infection. Adhering to the guidelines in ISO 11137 helps manufacturers to demonstrate their compliance with regulatory requirements and demonstrate to their customers and patients that their products are safe and effective.
It also promotes worldwide standardization of the radiation sterilization process, which in the end facilitates the trade of medical devices that have been sterilized with radiation between countries.
ISO 11137, along with other related ISO standards, provides a comprehensive and holistic approach to the development, validation, and control of radiation sterilization, it is beneficial for all the parties involve in the process and provides the assurance that the devices are suitable for their intended use and pose minimal risk to patients and users.
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Reference:
ISO 11137 — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137 — Part 2: Establishing the sterilization dose
ISO 11137— Part 3: Guidance on dosimetric aspects