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

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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).

Basic Data

Standard ID	GB/T 39381.1-2020 (GB/T39381.1-2020)
Description (Translated English)	Cardiovascular implants - Vascular device-drug combination products - Part 1: General requirements
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	30,342
Date of Issue	2020-11-19
Date of Implementation	2021-12-01
Regulation (derived from)	National Standard Announcement No. 26 of 2020
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration