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is the current text; anyone whose technical file or supplier agreement still cites an earlier one is working to a superseded document.
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Document preview — YY/T 0853-2024
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
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
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is the current text; anyone whose technical file or supplier agreement still cites an earlier one is working to a superseded document.
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 — 30 pages — is available in the English PDF.
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