ISO 11137-Gamma Sterilization Validation
Luckily, there are various notable techniques for cleaning clinical gadgets. This article, explicitly, will cover gamma illumination as a sanitization technique and its specialist ISO standard, ISO 11137.
What is ISO 11137?
The international standard ISO 11137 governs the use of radiation to sterilise healthcare products. It’s divided into three sections, each of which covers a different aspect of medical device radiation sterilisation:
ISO 11137-1: The requirements for establishing, validating, and controlling the radiation sterilisation process are covered in part one of the standard. It includes instructions for sterilising using the radionuclides Cobalt 60 and Cesium 137, which are the two most often utilised gamma emitting isotopes.
ISO 11137-2: The second part of the standard covers the process that manufacturers will use to establish the minimal dose required to achieve sterility. It also specifies the process for substantiating the sterilising dose of 25 or 15 kiloGrays (kGy). The gamma rays that are emitted as the radionuclide decays are measured in kiloGrays.
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:
- The desired Sterilization Assurance Level (SAL) is met using a minimum dose of radiation. The most regularly indicated SAL is 10-6, or one possibly unsterilized gadget for each million.
- Product functionality is not compromised by exceeding a maximum dose of radiation. A maximum dose must be established and not exceeded during gamma sterilization because gamma rays have the potential to break down the polymer that are used in many single-use medical devices that require sterilization.
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