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GB/T 12257-2023: Laser therapeutic equipment - He-Ne laser equipment
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
GB/T 12257-2023	English	179	Add to Cart	3 days [Need to translate]	Laser therapeutic equipment - He-Ne laser equipment
GB 12257-2000	English	399	Add to Cart	3 days [Need to translate]	General specification of He-Ne laser medical equipment
GB 12257-1990	English	RFQ	ASK	3 days [Need to translate]	The general specification of He-Ne laser device

GB/T 12257-2023: Laser therapeutic equipment - He-Ne laser equipment

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11:040:60 CCSC41 National Standards of People's Republic of China Replacing GB 12257-2000 Laser therapy equipment He-Ne laser therapy machine Released on 2023-05-23 2024-06-01 Implementation State Administration for Market Regulation Released by the National Standardization Management Committee

foreword

This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting: This document replaces GB 12257-2000 "General Technical Conditions for He-Ne Laser Therapy Machines": In addition to rectification and editorial changes, the main technical changes are as follows: ---Changed the scope of application of the standard (see Chapter 1, Chapter 1 of the:2000 edition); --- Deleted terms and definitions (see Chapter 3 of the:2000 edition); --- Deleted product composition and basic parameters (see Chapter 4 of the:2000 edition); --- Added "laser peak wavelength" (see 4:2:1); --- Changed the "laser mode" (see 4:2:2, 5:2:2 of the:2000 edition); --- Changed the "laser terminal output power" (see 4:2:3, 5:2:1, 5:6, 5:7 of the:2000 edition); --- Added "laser output mode and its time characteristics" (see 4:2:6); --- Added "the exposure limit of the treatment machine" (see 4:2:7); --- Added "aiming system (if applicable)" (see 4:3); --- Added "transmission system" (see 4:4, 5:8 of the:2000 edition); --- Changed the "timing device" (see 4:5, 5:5 of the:2000 edition); --- Added "Laser safety goggles (if applicable)" (see 4:6); --- Changed "Security" (see 4:7, 5:9, 5:10, 5:11 of the:2000 edition); --- Added "electromagnetic compatibility" (see 4:8); --- Changed the "environmental adaptability" (see 4:9, 5:15 of the:2000 edition); --- Deleted "marks and files" (see Section 5:11 of the:2000 edition); --- Deleted "painted parts" (see 5:12 of the:2000 edition); --- Deleted "electroplated parts" (see 5:13 of the:2000 edition); --- Deleted "aluminum parts" (see 5:14 of the:2000 edition): Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed and managed by the State Drug Administration: This document was drafted by: Zhejiang Institute of Medical Device Inspection, Jilin Keying Medical Laser Co:, Ltd:, Shanghai Shengchang Optoelectronics Co:, Ltd: Technology Co:, Ltd:, Tianjin Leiyi Laser Technology Co:, Ltd:, China Jiliang University: The main drafters of this document: Li Min, Du Kun, Shao Jianhua, Pan Daguang, Liu Hongmei, Huang Jie, Fang Chunzi, Chen Yi, Huang Dan, Sun Yu, Zhao Xiangrui: The release status of previous versions of this document and the documents it replaces are as follows: ---First published in:1990 as GB 12257-1990, first revised in:2000; --- This is the second revision: Laser therapy equipment He-Ne laser therapy machine

1 Scope

This document specifies the requirements and test methods for helium-neon laser therapy machines: This document is applicable to the helium-neon laser treatment machine (hereinafter referred to as the treatment machine) with a wavelength of 632:8nm for human body irradiation:

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document: GB 7247:1-2012 Safety of Laser Products Part 1: Equipment Classification and Requirements GB 9706:1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance GB 9706:222 Medical electrical equipment Part 2-22: Basic safety and fundamentals of surgical, orthopedic, therapeutic and diagnostic laser equipment Specific requirements for this performance GB/T 14710 Environmental requirements and test methods for medical electrical appliances YY/T 0758 General Requirements for Medical Laser Optical Fibers YY9706:102 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility Content requirements and tests

3 Terms and Definitions

This document does not have terms and definitions that need to be defined:

4 requirements

4:1 Normal working conditions The manufacturer shall at least specify the following normal operating condition parameters: --- ambient temperature; ---Relative humidity; ---using electric: 4:2 Therapeutic Lasers 4:2:1 Laser peak wavelength 632:8nm±10nm: 4:2:2 Laser mode Fundamental or higher-order modules: ...