YY 0599-2024Laser therapeutic equipment - Excimer laser corneal refractive treatment equipment (English PDF)

激光治疗设备准分子激光角膜屈光治疗机

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

July 8, 2024

Implementation date

July 20, 2027

Scope

YY 0599-2024 is the English-translated version of 激光治疗设备准分子激光角膜屈光治疗机.

YY 0599 is the mandatory standard for the excimer laser system used in corneal refractive surgery, the machine behind LASIK, PRK and their variants. An excimer laser removes corneal tissue by photoablation, breaking molecular bonds without heating the surrounding stroma, and the refractive outcome depends entirely on how precisely the ablation profile is delivered: energy per pulse, beam homogeneity, the eye tracking that keeps the pattern on target, and the calibration that keeps all of it stable between patients. The YY prefix without the /T suffix makes compliance compulsory in China. For a manufacturer or an importer of excimer platforms seeking Chinese registration, this is the governing standard.

Document preview — YY 0599-2024

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 8 July 2024 by the National Medical Products Administration and takes effect on 20 July 2027.

It is a YY standard without the /T suffix: compliance is mandatory in China.

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 — 15 pages — is available in the English PDF.

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