YY/T 1798-2021 Active Industry standards-Medicine

YY/T 1798-2021 Intrauterine compression balloon for single use

YY/T 1798-2021 Intrauterine compression balloon for single use

Publish Date: 2021-09-06 Implement Date: 2022-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1798-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Other specialized equipment
ICS Name: Surgical instruments and materials
Publish Date: 2021-09-06
Implement Date: 2022-09-01
Pages: 16 pages

Scope

This standard specifies the classification, requirements, test methods, marking, packaging, and user's manual, as well as transportation and storage and sterilization expiration date of single-use uterine compression balloons (hereinafter referred to as uterine compression balloons).
This standard applies to single-use uterine compression balloons that mechanically compress and stimulate the uterus to achieve temporary control or reduction of postpartum uterine bleeding.

Development Information

Word Count: 22 Thousand words Pages: 16 pages

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 15812.1-2005 Catheters other than intravascular catheters—Part 1:Test methods for common properties YY 0285.1-2017 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements 中华人民共和国药典(2020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 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings 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 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

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