GB 12264-1990
Replaced
GB/T 44138-2024
Active
National standards
GB/T 44138-2024 Cardiovascular implants—Cardiovascular absorbable implants
GB/T 44138-2024 Cardiovascular implants—Cardiovascular absorbable implants
Basic Information
Standard Code:
GB/T 44138-2024
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2024-06-29
Implement Date:
2025-07-01
Pages:
40 pages
Scope
This document specifies the general principles and requirements for the design evaluation of absorbable cardiovascular implants used to treat blood vessels and/or vascular regions (including the heart and the entire circulatory system). This document can be used as a supplement to specific device standards. This document applies to implants that come into direct contact with the cardiovascular system and are intended to function in the circulatory system. Note 1: Certain aspects of the absorbable components of cardiovascular drug-device combination products (such as coatings) are related to the content of the drug and are described in GB/T 39381.1. Note 2: The interpretation of absorbable, degradable, and related terms is provided in Appendix A. Note 3: This document does not specifically evaluate issues related to living tissues, living cells, and/or implants containing non-living biological materials and their derivatives. Additionally, procedures and devices used before and after the implantation of cardiovascular absorbable implants (such as balloon angioplasty devices) are not within the scope of this document if they do not affect the absorption of the implants. Absorbable cardiovascular implants may contain substances that can be considered pharmaceutical products (drugs) when used alone, but the drug effect is auxiliary to the implant and supports the main mode of action of the implant.
Development Information
Referenced Standards
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation
GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose
GB/T 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects
GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
GB/T 19974-2005 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
GB/T 39381.1-2020 Cardiovascular implants—Vascular device-drug combination products—Part 1:General requirements
YY/T 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
YY/T 0640-2016 Non-active surgical implants—General requirements
YY/T 0663-2008 Non active surgical implants—Particular requirements for cardiac and vascular implants—Specific requirements for arterial stents
YY/T 0663.1-2014 Cardiovascular implant—Endovascular devices—Part 1:Endovascular prostheses
YY/T 0663.1-2021 Cardiovascular implants—Endovascular devices—Part 1:Endovascular prostheses
YY/T 0663.2-2016 Cardiovascular implants Endovascular devices—Part 2:Vascular stents
YY/T 0663.2-2024 Cardiovascular implants—Endovascular devices—Part 2:Vascular stents
YY/T 0663.3-2016 Cardiovascular implants—Endovascular devices—Part 3:Vena cava filters
YY/T 1449.3-2016 Cardiovascular implants—Cardiac valve prostheses—Part 3:Heart valve substitutes implanted by transcatheter techniques
YY/T 1775.1-2021 Biological evaluation of absorbable medical devices—Part 1:Guidance for absorbable implants
Adopt standards
ISO/TS 17137:2021
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced