GB/T 39381.1-2020 English PDF (GBT39381.1-2020)

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GB/T 39381.1-2020: Cardiovascular implants - Vascular device-drug combination products - Part 1: General requirements
GB/T 39381.1-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 45
Cardiovascular Implants - Vascular Device-Drug
Combination Products - Part 1: General Requirements
(ISO 12417-1:2015, Cardiovascular Implants and Extracorporeal Systems –
Vascular Device-Drug Combination Products – Part 1: General Requirements,
MOD)
ISSUED ON: NOVEMBER 19, 2020
IMPLEMENTED ON: DECEMBER 01, 2021
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative References ... 7
3 Terms and Definitions ... 8
4 Intended Performance ... 12
5 Design Attributes ... 13
6 Materials ... 15
7 Design Evaluation ... 15
8 Manufacturing ... 32
9 Sterilization ... 35
10 Packaging ... 36
11 Information Supplied by the Manufacturer ... 36
Annex A (Informative) Definitions of Potential Clinical and Technical Events . 40
Bibliography ... 46
Foreword
GB/T 39381 Cardiovascular Implants – Vascular Device-Drug Combination Products
consists of the following 2 parts:
--- Part 1: General Requirements;
--- Part 2: Local Regulatory Guidance.
This Part is Part 1 of GB/T 39381.
This Part was drafted as per the rules specified in GB/T 1.1-2009.
This Part uses re-drafting method to modify and adopt ISO 12417-1:2015
Cardiovascular Implants and Extracorporeal Systems – Vascular Device-Drug
Combination Products – Part 1: General Requirements.
Compared with ISO 12417-1:2015, the technical differences and causes of this Part
are as follows:
--- For the normative references, this Part adjusts according to the technical
differences, so as to adapt to China’s technical conditions. The adjustment is
reflected in Clause 2 “Normative References”, which are specially as follows:
 Use GB/T 16886.1 that equivalently adopts the international standard to
replace ISO 10993-1;
 Use GB/T 16886.2 that equivalently adopts the international standard to
replace ISO 10993-2;
 Use GB/T 16886.7 that equivalently adopts the international standard to
replace ISO 10993-7;
 Use GB/T 19633.1 that equivalently adopts the international standard to
replace ISO 11607-1;
 Use GB/T 19974 that equivalently adopts the international standard to
replace ISO 14937;
 Use YY 0285.4 that equivalently adopts the international standard to replace
ISO 10555-4;
 Use YY 0450.1 that equivalently adopts the international standard to replace
ISO 11070;
 Use YY/T 0466.1 that equivalently adopts the international standard to
replace ISO 15223-1;
 Use YY/T 0663.2 that equivalently adopts the international standard to
replace ISO 25539-2.
--- Add the "solvent residue" to supplement the relevant requirements for the design
attributes of the drug-containing part of the device-drug combination products
(see 7.2.4.3.8 of this Edition).
--- Delete the "clinical evaluation" to avoid inconsistencies with Guidelines for
Medical Devices Clinical Evaluation (see 7.3 of ISO12417-1:2015).
This Part made the following editorial modifications:
--- Modify the standard name;
--- Delete the Annex B of ISO 12417-1:2015.
Please note some contents of this document may involve the patents. The issuing
agency of this document shall not assume the responsibility to identify these patents.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Committee for
Standardization of Implants for Surgery and Orthopaedic Devices (SAC/TC 110).
Drafting organizations of this Part: Tianjin Medical Device Quality Supervision and
Inspection Centre; Centre for Medical Device Evaluation, NMPA; Shanghai Microport
Medical (Group) Co., Ltd.; Lepu Medical Technology (Beijing) Co., Ltd.; and Medtronic
(Shanghai) Management Co., Ltd.
Chief drafting staffs of this Part: Duan Qingjiao, Ma Jinzhu, Zhu Lili, Cheng Maobo,
Han Zheng, Zhang Xiangmei, Li Yong, Xu Jiajia, and Chen Huimin.
Cardiovascular Implants – Vascular Device-Drug
Combination Products – Part 1: General Requirements
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 M...