GB/T 39381.1-2020 Active National standards

GB/T 39381.1-2020 Cardiovascular implants—Vascular device-drug combination products—Part 1:General requirements

GB/T 39381.1-2020 Cardiovascular implants—Vascular device-drug combination products—Part 1:General requirements

Publish Date: 2020-11-19 Implement Date: 2021-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 39381.1-2020

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2020-11-19

Implement Date: 2021-12-01

Pages: 30 pages

Scope

This part of GB/T 39381 specifies the requirements for the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and manufacturer-provided information of vascular drug-device combination products.
Note 1: Based on the diversity of the design of the combination products covered by this part and the latest developments of some combination products, the standardized in vitro test results and clinical study results are not always applicable. With scientific progress and the accumulation of clinical data, it is necessary to make appropriate amendments to this part.
This part applies to delivery systems or parts of delivery systems coated with drugs and constituting an integral component of vascular devices (such as drug-coated balloon catheters and drug-coated guidewires). This part also applies to non-permanently implanted vascular drug-device combination products.
This part does not apply to devices whose main function is to provide a drug delivery channel (such as infusion catheters), unless they contain drug components and are intended to provide auxiliary functions to the device part (such as central venous catheters coated with antibacterial drugs).
This part does not apply to procedures or devices (such as balloon angioplasty devices) introduced before or after vascular drug-device combination products, if they do not affect the drug-related characteristics of the combination devices.
This part includes the requirements for absorbable components (such as coatings) related to drugs in vascular drug-device combination products.

Development Information

Word Count: 58 Thousand words Pages: 30 pages

Referenced Standards

YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0640-2016 Non-active surgical implants—General requirements 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 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals 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 YY 0285.4-1999 Sterile,single-use intravascular catheters—Part 4:Balloon dilatation catheters YY 0285.4-2017 Intravascular catheters—Sterile and single-use catheters—Part 4:Balloon dilatation catheters YY 0450.1-2003 Accessory devices for sterile single-use intravascular catheters—Part 1:Introducers YY 0450.1-2020 Accessory devices for sterile single-use intravascular catheters—Part 1:Introducers 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 0663.2-2016 Cardiovascular implants Endovascular devices—Part 2:Vascular stents YY/T 0663.2-2024 Cardiovascular implants—Endovascular devices—Part 2:Vascular stents GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements

Adopt standards

ISO 12417-1:2015

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