YY 0336-2020 Active Industry standards-Medicine

YY 0336-2020 Sterile vaginal dilator for single use

YY 0336-2020 Sterile vaginal dilator for single use

Publish Date: 2020-03-31 Implement Date: 2021-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0336-2020
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Other specialized equipment
ICS Name: Surgical instruments and materials
Publish Date: 2020-03-31
Implement Date: 2021-04-01
Publisher: 国家药品监督管理局
Technical Committee: 全国计划生育器械标准化技术委员会(SAC/TC 169)
Pages: 13 pages

Scope

本标准规定了一次性使用无菌阴道扩张器(以下简称扩张器)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。

Development Information

Drafting Units:

上海市医疗器械检测所、上海衡仪器厂有限公司、河南省医疗器械检验所

Drafting Persons:

姚天平、王沪育、王海涛、翁秉豪、张峻梓、邹冰、钱心依

Word Count: 24 Thousand words Pages: 13 pages

Replace the following standards

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods 中华人民共和国药典 四部(2015年版) GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability) GB/T 9969-2008 General principles for preparation of instructions for use of industrial products GB 9969.1-1998 General principles for preparation of instructions for use of industrial products GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements GB/T 191-2025 Graphical symbols marking for handling and storage of packages GB/T 2829-2025 Sampling procedures and tables for periodic inspection by attributes(Apply to inspection of process stability)

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