Standard No.:	YY 0336-2013
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
Issued by:	China Food and Drug Administration
Issued on:	2013-10-21
Implemented on:	2014-10-1
Status:	superseded
Superseded by:	YY 0336-2020 Sterile vaginal dilator for single use
Superseded on:	2021-4-1
Superseding:	YY 0336-2002 Sterile vagina dilator for single use
Language:	English
File Format:	PDF
Word Count:	8000 words
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、使用说明书、运输、贮存和灭菌失效期的要求。
本标准适用于一次性使用的无菌阴道扩张器，该产品供妇产科检查用。
本标准不适用于手术用的阴道扩张器。