Johnson & Johnson, Raritan, NJ, USA.
STERIS Corporation, Leicester, UK.
J Hosp Infect. 2022 Aug;126:52-55. doi: 10.1016/j.jhin.2022.04.012. Epub 2022 May 1.
Cleaning and associated validation requirements are essential for the safe use of reusable devices. In the past, test methods and associated endpoints for cleaning validations have varied worldwide. Recent international standards have updated the requirements to include cleaning endpoints and requirements for the use of test soils for demonstrating cleaning efficacy of washer-disinfectors.
A quantitative comparison of test soils used in cleaning efficacy studies was conducted using a new standardized test method as published in Annexe B ISO 15883-5:2021. Test soils included Artificial Test Soil (ATS 2015), Blood Test Soil (BTS), Coagulated Blood, Defibrinated Blood Soil (DBLSO), Modified Coagulated Blood Soil, Two Component Blood Test Soil and the UK Test Soil (Edinburgh Soil).
All the test soils demonstrated acceptable performance in accordance with the standard.
清洁及相关验证要求对于可重复使用设备的安全使用至关重要。过去,全球范围内清洁验证的测试方法和相关终点各不相同。最近的国际标准更新了要求,包括清洁终点以及使用测试土来证明清洗消毒器清洁效果的要求。
使用新发布的 ISO 15883-5:2021 附录 B 中规定的标准化测试方法,对清洁效果研究中使用的测试土进行了定量比较。测试土包括人工测试土(ATS 2015)、血测试土(BTS)、凝结血、去纤维蛋白血土(DBLSO)、改良凝结血土、双组份血测试土和英国测试土(爱丁堡土)。
所有测试土均按照标准要求表现出可接受的性能。