GB 8662-1988
Replaced
YY/T 1758-2020
Active
Industry standards-Medicine
YY/T 1758-2020 Cardiovascular implants—Pulmonary valve conduit
YY/T 1758-2020 Cardiovascular implants—Pulmonary valve conduit
Basic Information
Standard Code:
YY/T 1758-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2020-09-27
Implement Date:
2021-09-01
Pages:
12 pages
Scope
This standard specifies the basic requirements for pulmonary artery valved conduits.
This standard applies to pulmonary artery valved conduits used to correct or reconstruct the right ventricular outflow tract.
This standard does not apply to prostheses derived from allogeneic and autologous tissues (autologous transplants).
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 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
YY 0500-2004 Cardiovasular implants—Tubular vascular prostheses
YY/T 1449.3-2016 Cardiovascular implants—Cardiac valve prostheses—Part 3:Heart valve substitutes implanted by transcatheter techniques
YY/T 1564-2017 Cardiovascular implants—Pulmonary valve conduit—Pulsatile flow test methods
《中国人民共和国药典》2015年版四部
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
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 12279-1990 Cardiac valve prostheses general technical specification
GB 12279-2008 Cardiovasular implants—Cardiac valve prostheses
GB/T 12279.1-2024 Cardiovascular implants—Cardiac valve prostheses—Part 1:General requirements
GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes
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 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
YY/T 0313-1998 Package,lable,transport and storage for medical polymer products
YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer
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 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling
YY/T 0771.3-2009 Animal-derived medical devices - Part 3: Verification of removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) factors
GB/T 12279.3-2025 Cardiovascular implants—Cardiac valve prostheses—Part 3:Heart valve substitutes implanted by transcatheter techniques
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