GB/T 39381.1-2020Cardiovascular implants - Vascular device-drug combination products - Part 1: General requirements (English PDF)

1 Scope

This part of GB/T 39381 specifies the requirements for the intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer, etc. of the vascular device-drug combination products (VDDCPs).

NOTE 1: Due to variations in the design of combination products covered by this Part and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific development and clinical data accumulation, appropriate revision of this Part might be necessary.

Delivery systems or parts of the delivery system are included in the scope of this Part, if they comprise an integral component of the vascular device and if they are drug- covered (e.g.: drug-covered balloon catheters and drug-covered guidewires). This Part is also applicable to the non-permanent implantable VDDCPs.

Devices whose PMOA is to provide a conduit for delivery of a drug, are excluded from the scope of this Part (e.g.: infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g.: antimicrobial coated central venous catheter).

Procedures and devices used prior to and following the introduction of the VDDCP (e.g.: balloon angioplasty devices) are excluded from the scope of this Part if they do not affect the drug-related aspects of the device.

This Part includes the requirements for the absorbable components (such as coating) related to the device drug in the VDDCPs.

NOTE 2: See also ISO/TS 17137.

This Part does not address issues associated with viable or non-viable biological materials such as tissues, cells, or proteins.

This Part does not address issues associated with active surgical implants (i.e.:

implants that require power not generated by the human body or gravity).

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.

GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and

Testing within a Risk Management Process (GB/T 16886.1-2011, ISO 10993-

1:2009, IDT)

GB/T 16886.2 Biological Evaluation of Medical Devices - Part 2: Animal Welfare

Requirements (GB/T 16886.2-2011, ISO 10993-2:2006, IDT)

GB/T 16886.7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide

Sterilization Residuals (GB/T 16886.7-2015, ISO 10993-7:2008, IDT)

GB/T 19633.1 Packaging for Terminally Sterilized Medical Devices - Part 1:

Requirements for Materials, Sterile Barrier Systems and Packaging Systems (GB/T 19633.1-2015, ISO 11607-1:2006, IDT)

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,

ISO 14937:2009, IDT)

YY 0285.4 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4:

Balloon Dilatation Catheters (YY 0285.4-2017, ISO 10555-4:2013, MOD)

YY/T 0316-2016 Medical Devices - Application of Risk Management to Medical

Devices (ISO 14971:2007 corrected version, IDT)

YY 0450.1 Accessory Devices for Sterile Single-Use Intravascular Catheters -

Part 1: Introducers (YY 0450.1-2003, ISO 11070:1998, IDT)

YY/T 0466.1 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, ISO 15223-1:2012, IDT)

YY/T 0640-2016 Non-Active Surgical Implants - General Requirements (ISO 14630:2012, IDT)

YY/T 0663.2 Cardiovascular Implants Endovascular Devices - Part 2: Vascular

Stems (YY/T 0663.2-2016, ISO 25539-2:2012, MOD)

YY/T 1680 | YY/T 1571 | GB 24436 | GB/Z 44426.7 | […]