GB 8662-1988
Replaced
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
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
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
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced