GB/T 39381.1-2020
Cardiovascular implants—Vascular device-drug combination products—Part 1：General requirements
- Standard No.
- GB/T 39381.1-2020
- Language
- Chinese
- Release Date
- 2020
- Published By
- 国家市场监督管理总局、中国国家标准化管理委员会
- Lastest
- GB/T 39381.1-2020
- Scope
- This part of GB/T39381 specifies the requirements for expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information provided by the manufacturer of vascular drug-device combination products. Note 1: Based on the diversity of combination product designs covered by this section and the latest development of some combination products, reasonable standardized in vitro test results and clinical research results are not always applicable. With scientific progress and accumulation of clinical data, it is necessary to make appropriate revisions to this section. This standard applies to delivery systems that are drug-coated and form an integral component of a vascular device or are part of a delivery system (such as drug-coated balloon catheters and drug-coated guidewires). This section also applies to non-permanently implanted vascular drug-device combination products. This section does not apply to devices whose main function is to provide drug delivery channels (such as infusion catheters), unless they contain drug components and are expected to provide auxiliary effects to the device part (such as central venous catheters coated with antibacterial drugs). This section does not apply to procedures or devices (such as balloon angioplasty devices) before or after the introduction of vascular drug-device combination products, if they do not affect the drug-related properties of the combination device. This part includes requirements for absorbable components (such as coatings) related to device drugs in vascular drug-device combination products. Note 2: Refer to ISO/TS17137. This section does not include active and inactive biological materials, such as tissues, cells or proteins. This section does not include active surgical implants (i.e. implants that require an external supply of energy other than the human body or gravity).
GB/T 39381.1-2020 Referenced Document
- GB/T 19633 Packaging for terminally sterilized medical devices
- GB/T 19974 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
- ISO 14971:2007 Medical devices - Application of risk management to medical devices
- YY/T 0316-2016 Medical devices.Application of risk management to medical devices
- YY/T 0640-2016 Non-active surgical implants.General requirements
- YY/T 0663 Non active surgical implants.Particular requirements for cardiac and vascular implants.Specific requirements for arterial stents
GB/T 39381.1-2020 history
- 2020 GB/T 39381.1-2020 Cardiovascular implants—Vascular device-drug combination products—Part 1：General requirements