YY/T 0853-2024Medical compression hosiery for varices (English PDF)

医用静脉曲张压力袜

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 7, 2024

Implementation date

March 1, 2025

Scope

YY/T 0853-2024 is the English-translated version of 医用静脉曲张压力袜.

YY/T 0853 governs medical compression hosiery, the graduated-pressure stockings prescribed for varicose veins and for the prevention of venous thromboembolism. It sets the requirements such hosiery has to meet and the test methods that verify them, covering the compression it delivers, how that compression is graded along the limb, the durability of the material and the marking and information the product carries. It is the standard against which a Chinese regulator judges whether a compression stocking may be sold as a medical device rather than as ordinary hosiery, and the reference a foreign manufacturer is asked for when registering a product in China. The 2024 edition is the current text; anyone whose technical file or supplier agreement still cites an earlier one is working to a superseded document.

Document preview — YY/T 0853-2024

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword
1 Scope
2 Normative references
3 Terms and definitions
About this edition
Classification and status
How a Chinese national standard is set out
About this English translation

Foreword

This document was issued on 7 February 2024 by the National Medical Products Administration and takes effect on 1 March 2025.

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.

1 Scope

Remaining clauses in the full document

2 Normative references
3 Terms and definitions
About this edition
Classification and status
How a Chinese national standard is set out
About this English translation

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.

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