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

Publish Date: 2020-09-27 Implement Date: 2021-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 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

Word Count: 16 Thousand words Pages: 12 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 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

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