Standard No.:	YY 0336-2020
English Name:	Sterile vaginal dilator for single use
Chinese Name:	一次性使用无菌阴道扩张器
Chinese Classification:	C36    Other special devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2020-03-31
Implemented on:	2021-4-1
Status:	valid
Superseding:	YY 0336-2013 Sterile vaginal dilator for single use
Target Language:	English
File Format:	PDF
Word Count:	8000 words
Translation Price(USD):	240.0
Delivery:	via email in 1~3 business day

本标准规定了一次性使用无菌阴道扩张器产品的结构型式与基本尺寸、要求、试验方法、检验规则、标志、包装和使用说明书、运输、贮存、灭菌失效期的要求。
本标准适用于妇产科诊查和清洗阴道时使用的一次性使用无菌阴道扩张器。本标准不适用于手术用的阴道扩张器。