YY 0336-2013 Replaced Industry standards-Medicine

YY 0336-2013 Sterile vaginal dilator for single use

YY 0336-2013 Sterile vaginal dilator for single use

Publish Date: 2013-10-21 Implement Date: 2014-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0336-2013

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Other specialized equipment

ICS Name: Surgical instruments and materials

Publish Date: 2013-10-21

Implement Date: 2014-10-01

Pages: 12 pages

Scope

This standard specifies the structural type and basic dimensions, requirements, test methods, inspection rules, marking, packaging, and user manuals, as well as the requirements for transportation, storage, and sterilization expiration dates of single-use sterile vaginal dilators (hereinafter referred to as "dilators").
This standard applies to single-use sterile vaginal dilators, which are used for gynecological examinations.
This standard does not apply to vaginal dilators used in surgery.

Development Information

Word Count: 22 Thousand words Pages: 12 pages

Replace the following standards

YY 0336-2002 Sterile vagina dilator for single use

Superseded by the following standards

YY 0336-2020 Sterile vaginal dilator for single use

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 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 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals 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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YY 0054-2003 Replaced

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Publish Date: 2003-06-20