GB 8662-1988
Replaced
YY/T 1704.3-2021
Active
Industry standards-Medicine
YY/T 1704.3-2021 Cervical dilator for single use—Part 3:Ripening balloon
YY/T 1704.3-2021 Cervical dilator for single use—Part 3:Ripening balloon
Basic Information
Standard Code:
YY/T 1704.3-2021
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 part of YY/T 1704 specifies the classification, requirements, test methods, marking, packaging, and user manuals, as well as the transportation, storage, and sterilization expiration dates of single-use cervical dilator balloon devices (hereinafter referred to as balloon cervical dilators).
This part applies to balloon dilators used to dilate immature cervixes in women before full-term induction of labor.
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
YY 0285.4-2017 Intravascular catheters—Sterile and single-use catheters—Part 4:Balloon dilatation catheters
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
YY/T 0586-2005 Medical polymer products—Test methods of radiopacity
YY/T 0586-2016 Medical polymer products-Test methods of radiopacity
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