YY 0845-2011 Active Industry standards-Medicine

YY 0845-2011 Laser therapeutic equipment—Diode laser equipment for photodynamic therapy

YY 0845-2011 Laser therapeutic equipment—Diode laser equipment for photodynamic therapy

Publish Date: 2011-12-31 Implement Date: 2013-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 0845-2011

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical ultrasound, laser, and high-frequency instruments and equipment

ICS Name: Treatment equipment

Publish Date: 2011-12-31

Implement Date: 2013-06-01

Pages: 10 pages

Scope

This standard specifies the terms and definitions, product composition, basic parameters, technical requirements, test methods, and inspection rules for semiconductor laser photodynamic therapy machines.
This standard applies to semiconductor laser photodynamic therapy machines (hereinafter referred to as therapy machines), which use laser of a specific wavelength and photosensitizers to produce a photochemical reaction, and are used by clinical units for photodynamic therapy.

Development Information

Word Count: 17 Thousand words Pages: 10 pages

Referenced Standards

GB 9706.19-2000 Medical electrical equipment—Part 2:Particular requirements for the safety of endoscopic equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 17736-1999 Testing method of main parameters for laser protective eyewear YY/T 0758-2009 General requirements for therapeutic laser fiber YY 91057-1999 ISO 11146(所有部分) GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 7247.1-2001 Safety of laser products—Part 1:Equipment classification, requirements and user's guide GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.20-2000 Medical electrical equipment—Part 2:Particular requirements for the safety of diagnostic and therapeutic laser equipment GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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