ISO 11137 – Gamma Sterilization Validation an introduction
绝育是许多医疗设备制造商在推出产品之前必须克服的最终挑战之一。但是，这并不意味着它可以（或应该）作为补充。患者和用户面临未经灭菌或不充分灭菌设备的危险。
幸运的是，清洁临床小工具有各种知名技术。本文明确将涵盖伽玛照明作为一种消毒技术及其专家ISO标准ISO 11137。
- Operon strategist isISO 13485顾问who helps to create the document for ISO 13485 certificate. For more details on ISO 13485 certificate process联系我们OrWhatsApp Us
什么是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.
ISO 11137-3：Section 3 of the standard provides manufacturers with information on how to achieve the standards of part one, which pertain to dosimetry (the measurement of gamma ray dose) and its role in planning, validating, and managing the sterilizing process.
How does Gamma sterilization of medical device work?
对医疗设备进行消毒的最常见方法之一是伽马射线。像X射线一样，伽马射线是一种电磁辐射。另一方面，伽马射线具有更高的能量，并且可能会穿透塑料（例如塑料）以杀死先前包装的设备上的细菌。辐射源（通常是钴60，但有时是剖宫产137）被放置在辐射固定的房间中以开始消毒过程。然后将包装的医疗设备引入并围绕辐射源循环，以使产品的所有侧面都暴露于伽马射线。
Gamma irradiation, unlike other sterilising procedures such as ethylene oxide (EO), does not require specific humidity, temperature, or pressure controls. The gamma sterilisation technique also doesn\’t raise the temperature of the objects being sterilised, making it excellent for heat-sensitive gadgets. It\’s worth noting that the future supply of the required isotopes is unknown. Because the global supply of cobalt-60 is currently insufficient to keep up with the rate of decay, the capacity of gamma irradiation facilities is limited.
Operon Strategist is a188金宝慱亚洲体育为医疗保健行业的各种制造商提供监管指导的公司，以确保这些制造商的战略发展。
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.
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.
这些程序旨在用于使用至少100个产品的大批量项目。当不可能将数百个设备分组在一起时，将第三种方法（称为VDMAX）用于较小的批处理中创建的项目。这种方法评估了预定的剂量：对于伽马射线的耐受性较小，而不是找到达到SAL 10-6所需的最低剂量的物品，要么25 kgy或15 kgy。根据ISO 11137的数据，制造商必须执行季度剂量审核，作为持续过程验证的一部分，无论使用哪种方法。
