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YY/T 0663.1-2021Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (English PDF)

心血管植入物血管内器械第1部分：血管内假体

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 6, 2021

Implementation date

September 1, 2022

Scope

YY/T 0663.1-2021 is the English-translated version of 心血管植入物血管内器械第1部分：血管内假体.

It is the longest document in the series at 45,500 words, and the requirements reflect a device that has to be crimped into a delivery catheter, navigated through diseased vessels, deployed accurately at the first attempt and then hold for decades against pulsatile pressure and a changing aorta.

Fabric integrity, fixation, migration resistance and endoleak behaviour are the properties the evaluation turns on. For a manufacturer or an importer of aortic stent grafts seeking Chinese registration, this is the governing standard.

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Document preview — YY/T 0663.1-2021

National Standard of the People's Republic of China

Classification: C36

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions

Foreword

This document was issued on 6 September 2021 by the National Medical Products Administration and takes effect on 1 September 2022.

It is a YY/T standard: it is recommended rather than compulsory, but it is the method a Chinese reviewer applies when assessing a registration submission.

It is classified under Chinese classification C36.

1 Scope

YY/T 0663.1 is Part 1 of the Chinese endovascular device series, covering the endovascular prosthesis: the stent graft used to exclude an aortic aneurysm from the circulation without opening the chest or abdomen. It is the longest document in the series at 45,500 words, and the requirements reflect a device that has to be crimped into a delivery catheter, navigated through diseased vessels, deployed accurately at the first attempt and then hold for decades against pulsatile pressure and a changing aorta. Fabric integrity, fixation, migration resistance and endoleak behaviour are the properties the evaluation turns on. For a manufacturer or an importer of aortic stent grafts seeking Chinese registration, this is the governing standard.

Remaining clauses in the full document

2 Normative references
3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 161 pages — is available in the English PDF.

Similar standards

YY/T 0079|YY/T 0979|YY 0091|YY/T 0663.2|YY 0336

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