标准摘要
[中文适用范围]： 本IEC 61010标准规定了在医疗、兽医、制药和实验室领域，用于灭菌、清洗和消毒医疗材料的电气设备的安全要求，使用时需满足环境条件1.4的要求。此类设备的示例包括：a) 使用蒸汽和/或热水作为灭菌剂的灭菌器和消毒器；b) 使用有毒气体、有毒气溶胶或有毒蒸气作为灭菌剂的灭菌器和消毒器；c) 使用热空气或热惰性气体作为灭菌剂的灭菌器和消毒器；d) 清洗机-消毒器。本文件不适用于以下类型的设备：a) 用于危险大气环境的设备（见IEC 60079），但适用于设备内部由易燃灭菌剂产生的大气环境；b) 用于除灭菌或消毒以外的加热材料的实验室设备（见IEC 61010-2-010）；c) 洗衣设备（见IEC 60335-2-4、IEC 60335-2-7、IEC 60335-2-11、ISO 10472（所有部分）），除非设计用于消毒医疗材料；d) 洗碟机（见IEC 60335-2-5和IEC 60335-2-58）。 [外文原描述]： IEC 61010-2-040:2020 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. Examples of such equipment include the following: - sterilizers and disinfectors using steam and/or hot water as the sterilant; - sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant; - sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and - washer-disinfectors. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - it is established on the basis of the third edition (2010) of IEC 61010‑1 and its Amendment 1 (2016); - added tolerance for stability of a.c. voltage test equipment to 6.8.3.1; - the status of a Group Safety Publication has been removed (this does not change the technical requirements in the document).
英文名称Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials