YY 0284-2004The general specification of He-Ne laser medical instrument for ILIB (English PDF)

YY 0284-2004 is the English-translated version of 氦氖激光血管内照射治疗仪通用技术条件.

Intravascular laser irradiation of blood is the subject of YY 0284-2004, a mandatory Chinese medical device standard for the helium-neon laser instruments used for it.

The standard gives the definitions, the classification, the requirements, the test methods and the sampling rules, together with marking, labelling and packaging.

It covers low-power helium-neon instruments working in continuous wave at 632.8 nm for the treatment of blood circulation, and multifunction instruments carrying an intravascular helium-neon channel are to follow it as well.

Where an instrument uses another source and has no standard of its own, it can serve as a guide to safety requirements, without that instrument's particular needs.

It replaces YY 0284-1996 and cites GB 7247.1-2001, GB 9706.1-1995, GB 9706.20-2000, GB/T 14233.1-1998, GB/T 14710-1993 and YY 91055-1999 among others. Issued on 23 March 2004, it has applied since 1 January 2005.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.

YY 0844-2011|YY 9706.257-2021|YY 91146-1999|GB 9706.222-2022|YY/T 0758-2021|YY/T 1914-2023

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