ISO 11137 - 伽马灭菌验证介绍
Sterilization is one of the final challenges that many medical device manufacturers must overcome before their product may be launched. However, this does not mean that it may (or should) be handled as an addition. Patients and users are at danger from unsterilized or inadequately sterilized equipment.
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.
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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：标准的第一部分涵盖了建立，验证和控制辐射灭菌过程的要求。它包括使用放射性核素钴60和Cesium 137进行灭菌的说明，这是两种经常使用的伽玛发射同位素。
ISO 11137-2：标准的第二部分涵盖了制造商将用来确定实现不育所需的最小剂量的过程。它还指定了证实25或15公里（KGY）的灭菌剂量的过程。作为放射性核素衰变发出的伽马射线以千差线进行测量。
ISO 11137-3:该标准的第3节为制造商提供了有关如何实现第一部分标准的信息，该标准与剂量法有关（伽马射线剂量的测量）及其在计划，验证和管理消毒过程中的作用。
医疗设备的伽马绝育如何工作？
消毒我最常见的方法之一dical devices is gamma irradiation. Gamma rays, like X-rays, are a kind of electromagnetic radiation. Gamma rays, on the other hand, have a considerably higher energy and may penetrate materials like plastic to kill bacteria on previously packaged equipment. The radiation source (typically Cobalt 60, but sometimes Caesium 137) is placed in a radiation-shielded room to begin the sterilising procedure. Packaged medical devices are then brought in and circulated around the source of radiation so that all sides of the product are exposed to the gamma rays.
与其他灭菌程序（例如氧化乙烷（EO））不同，γ辐射不需要特定的湿度，温度或压力控制。伽马灭菌技术也不会升高被灭菌的物体的温度，从而使其非常适合热敏小工具。值得注意的是，所需同位素的未来供应尚不清楚。由于目前全球钴60的供应不足以跟上衰减速度，因此伽马射线设施的能力有限。
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根据ISO 11137，伽马灭菌验证的相互作用是什么？
ISO 11137中构建的伽马消毒批准过程旨在保证两个基本结果：
- 使用最小辐射剂量达到所需的灭菌保证水平（SAL）。 The most regularly indicated SAL is 10-6, or one possibly unsterilized gadget for each million.
- 产品功能不会因超过最大辐射剂量而损害。 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指定了确定满足这两个标准的辐射剂量的三种方法。前两种方法相似，因为它们包括确定天然生物负担（产品上的细菌量）和不育测试以确认适当的剂量。
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 utilised 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.