YY/T 0679-2016 in English

本标准规定了医用低温蒸汽甲醛灭菌器的术语、定义、标记、要求、试验方法、标志、使用说明书、包装、运输和贮存要求。本标准适用于利用低温蒸汽和甲醛混合气体对不耐热医疗器械进行灭菌的灭菌器。

Scope

This standard specifies the terms and definitions, types and markings, requirements, test methods, markings and instructions for use, packaging, transportation and storage of medical low-temperature steam formaldehyde sterilizers (hereinafter referred to as sterilizers). The sterilizers specified in this standard mainly use low-temperature steam and formaldehyde mixed gas to sterilize heat-sensitive medical items. This standard does not involve the effectiveness confirmation and daily quality control requirements of the low-temperature steam formaldehyde sterilization process, but the test methods and equipment in this standard can be used as a reference for the verification and daily control of sterilizers. This standard does not specify safety requirements involving the scope of risk of use.