YY/T 0663.2-2016: Cardiovascular implants Endovascular devices--Part 2: Vascular stents

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY/T 0663.2-2016 (Self-service in 1-minute)
Newer / historical versions: YY/T 0663.2-2016

Preview True-PDF

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.

Basic Data

Standard ID	YY/T 0663.2-2016 (YY/T0663.2-2016)
Description (Translated English)	Cardiovascular implants Endovascular devices--Part 2: Vascular stents
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	82,813
Date of Issue	2016-07-29
Date of Implementation	2017-06-01
Issuing agency(ies)	State Food and Drug Administration