YY/T 0663.2-2016 English PDF (YYT0663.2-2016)

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YY/T 0663.2-2016: Cardiovascular implants Endovascular devices--Part 2: Vascular stents
YY/T 0663.2-2016
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 45
Partially replacing YY/T 0663-2008
Cardiovascular implants Endovascular devices -
Part 2: Vascular stents
(ISO 25539-2:2012, MOD)
ISSUED ON: JULY 29, 2016
IMPLEMENTED ON: JUNE 01, 2017
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
Introduction ... 5 
1 Scope ... 6 
2 Normative references ... 6 
3 Terms and definitions ... 7 
4 General requirements ... 10 
5 Intended performance ... 11 
6 Design attributes ... 11 
7 Materials ... 13 
8 Design evaluation ... 14 
9 Post-market surveillance ... 45 
10 Manufacturing ... 45 
11 Sterilization ... 45 
12 Packaging ... 46 
Annex A (Informative) Attributes of endovascular devices - Vascular stents -
Technical and clinical consideration ... 50 
Annex B (Informative) Bench and analytical tests ... 57 
Annex C (Informative) Definitions of reportable clinical events ... 61 
Annex D (Informative) Test methods ... 64 
Annex E (Informative) Supplement to fatigue durability test analytical approach
... 113 
Bibliography ... 116 
Foreword
YY/T 0663 "Cardiovascular implants Endovascular devices" includes the
following three parts:
- Part 1: Endovascular prostheses;
- Part 2: Vascular stents;
- Part 3: Vena cava filters.
This Part is Part 2 of YY/T 0663.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces the part related to vascular stents in YY/T 0663-2008 "Non
active surgical implants - Particular requirements for cardiac and vascular
implants - Specific requirements for arterial stents". Since the date of
implementation of this Part, the part related to vascular stents in YY/T 0663-
2008 is abolished. Compared with YY/T 0663-2008, the main technical changes
in this Part are as follows:
- Modify the scope of application of the standard. The scope of application of
this Part includes vascular stents and their delivery systems, excluding
endovascular prostheses;
- Modify the structure and content of the design evaluation section;
- ADD Annex A, to give technical and clinical consideration for stents and
delivery systems;
- ADD Annex D, to provide a reference test method for preclinical in vitro
testing;
- ADD Annex E, to provide supplemental information on fatigue durability test
analytical approach.
This Part uses the redraft law to modify and adopt ISO 25539-2:2012
"Cardiovascular implants - Endovascular devices - Part 2: Vascular stents".
Compared with ISO 25539-2:2012, the following changes have been made in
this Part:
- This Part puts some of the content from the Scope of ISO 25539-2:2012
into the Introduction;
- For the normative references of ISO 25539-2:2012, this Part replaces the
corresponding international standards with national standards and industry
standards identical to the corresponding international standards;
- For ISO 25539-2:2012 "Bibliography", this Part replaces the corresponding
international and foreign standards with domestic documents;
- Modify "pressure per unit length" in D.5.3.4.6 of ISO 25539-2:2012 to
"pressure" and the unit from "kPa/mm" to "kPa".
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority of this document shall
not be held responsible for identifying any or all such patent rights.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of Subcommittee 2 on Cardiovascular
Implants, National Technical Committee 110 on Implants for Surgery and
Orthopedic Devices of Standardization Administration of China (SAC/TC
110/SC 2).
Drafting organizations of this Part: Tianjin Medical Devices Quality Supervision
and Testing Center, Shanghai MicroPort Medical (Group) Co., Ltd., Lepu
Medical Technology (Beijing) Co., Ltd.
Main drafters of this Part: Jiao Yongzhe, Miao Hui, Zhang Zhenghui, Fan Bo, Li
Yong, Sun Bing, Jiang Bo, Xu Jiajia.
This Part replaces the part related to vascular stents in YY/T 0663-2008.
The previous editions of the standard replaced by YY/T 0663 this were released
as follows:
- YY/T 0663-2008;
- YY/T 0663.1-2014.
Cardiovascular implants Endovascular devices -
Part 2: Vascular stents
1 Scope
1.1 This Part of YY/T 0663 specifies requirements for vascular stents, based
upon current medical knowledge. With regard to safety, it gives requirements
for intended performance, design attributes, materials, design evaluation,
manufacturing, sterilization, packaging and information supplied by the
manufacturer.
1.2 The scope of this Part includes vascular stents used to treat vascular lesions
or stenoses, or other vascular abnormalities. These devices might or might not
incorporate surface modifications of the stent such as drug and/or other
coatings.
1.3 Delivery systems are included in this Part if they comprise an integral
component of the deployment of the vascular stent.
1.4 Procedures and devices used prior to the introduction of the vascular stent,
such as balloon angioplasty devices, are excluded from the scope of this Part.
1.5 Degradation and other time-dependent aspects of bioabsorbable and
polymeric stents and coatings are not addressed by this Part.
1.6 With the exception of sterilization, this Part does not address requirements
for the evaluation of animal tissue products.
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are 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 18278.1 Sterilization of health care products - Moist heat - Part 1:
Requirements for the development, validation and routine control of a
sterilization process for medical devices (GB 18278.1-2015, ISO 17665-
1:2006, IDT)
GB 18279.1 Sterilization of health care products - Ethylene oxide - Part 1:
Requirements for development, validation and routine control of a
sterilization process for medical devices (GB 18279.1-2015, ISO 11135-
1:2007, IDT)
GB 18280 Sterilization of health care products - Requirement for validation
and routine control - Radiation sterilization (GB 18280-2000, ISO 11137:1995,
IDT)
GB/T 19633 Packaging for terminally sterilized medical devices (GB/T
19633-2005, ISO 11607:2003, 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-
2005, ISO 14937:2000, IDT)
YY/T 0297 Clinical investigation of medical devices (YY/T 0297-1997, ISO
14155:1996, IDT)
YY/T 0316-2008 Medical devices - Application of risk management to
medical devices (ISO 14971:2007, IDT)
YY/T 0640-2016 Non-active surgical implants - General requirements (ISO
14630:2012, IDT)
YY 0970 Sterilization of single-use medical devices incorporating materials
of animal origin - Validation and routine control of sterilization by liquid
sterilant (YY 0970-2013, ISO 14160:19...