ISO 11137 – Gamma Sterilization Validation: An Introduction
Sterilization is a critical step in ensuring the safety of medical devices before they reach patients. Among various techniques, gamma irradiation stands out, governed by ISO 11137 standards. This method effectively eliminates microorganisms, safeguarding against infection risks. Manufacturers must adhere to rigorous sterilization protocols to uphold patient safety and regulatory compliance.
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What is ISO 11137?
The international standard ISO 11137 governs the use of radiation to sterilize healthcare products. It’s divided into three sections, each of which covers a different aspect of medical device radiation sterilization:
ISO 11137-1 details protocols for validating and controlling the radiation sterilization process, particularly using Cobalt 60 and Cesium 137, the predominant gamma-emitting isotopes in medical device sterilization.
ISO 11137-2 outlines procedures for determining the minimum radiation dose needed for sterilization and verifying doses of either 25 or 15 kiloGrays, measured in gamma ray emissions.
ISO 11137-3 guides manufacturers in meeting the standards of part one by detailing dosimetry’s crucial role in planning, validating, and managing the sterilization process.
How Does Gamma Sterilization of Medical Devices Work?
Gamma irradiation is a common method for sterilizing medical devices. Unlike X-rays, gamma rays possess higher energy, penetrating materials like plastic to eliminate bacteria on packaged equipment. Typically utilizing Cobalt 60 or Cesium 137 as a radiation source, devices are exposed in a shielded room, ensuring thorough sterilization from all angles
Operon Strategist is a medical device consulting company that provides regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.
What Is The Interaction For Gamma Sterilization Validation As Per ISO 11137?
The gamma disinfection approval process framed in ISO 11137 is intended to guarantee two basic results:
- To achieve the desired Sterilization Assurance Level (SAL) of 10^-6, a minimum radiation dose is utilized, ensuring one potentially unsterilized device per million.
- Exceeding a maximum radiation dose is avoided during gamma sterilization to maintain product functionality and prevent polymer breakdown in single-use medical devices.
ISO 11137-2 specifies three methods for determining a radiation dosage that satisfies both of these criteria. The first two methods are similar in that they include determining the natural bio burden—the quantity of germs on a product—and sterility testing to confirm the proper dose.
These procedures are intended for usage with large-batch items that require at least 100 units of the product. When grouping hundreds of devices together is not possible, the third method, known as VDmax, is utilized for items created in smaller batches. This approach evaluates a predetermined dose: either 25 kGy or 15 kGy for items with a lesser tolerance for gamma rays, rather than finding the minimum dose required to attain SAL 10-6. Manufacturers must execute quarterly dosage audits as part of continuing process validation, regardless of the method utilized, according to ISO 11137.
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Ready to achieve flawless compliance with ISO 11137 standards? Partner with Operon Strategist, the leading medical device consulting company, for unparalleled expertise in gamma sterilization validation. We help manufacturers navigate the complexities of ISO 11137 and ISO 13485, ensuring robust regulatory compliance and optimal patient safety. Contact us today for comprehensive guidance on gamma sterilization validation and ISO 13485 certification support
