YY 0071-2008 in English

本标准规定了直肠、乙状结肠窥镜的分类、要求、试验方法、检验规则、标志、使用说明书、包装、运输和贮存的要求。
本标准适用于直肠、乙状结肠窥镜，窥镜主要用于检查肛肠内病变和／或配合常规手术器械进行治疗。
本标准不适用于具有光学系统的窥镜。

Scope

This standard specifies the classification, requirements, test methods, inspection rules, markings, instructions for use, packaging, transportation and storage requirements for rectal and sigmoidoscopes. This standard applies to rectal and sigmoid colonoscopes (hereinafter referred to as speculum). The speculum is mainly used to examine anorectal lesions and/or to be treated with conventional surgical instruments. This standard does not apply to scopes with optical systems.