GB/T 12257-2023 Active National standards

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

Publish Date: 2023-05-23 Implement Date: 2024-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 12257-2023

Standard Type: National 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: 2023-05-23

Implement Date: 2024-06-01

Publisher: 国家市场监督管理总局、国家标准化管理委员会

Technical Committee: 国家药品监督管理局

Pages: 7 pages

Scope

本文件规定了氦氖激光治疗机的要求和试验方法。本文件适用于波长为632.8 nm，用于人体照射的氦氖激光治疗机（以下简称治疗机)。

Development Information

Drafting Units:

浙江省医疗器械检验研究院、吉林省科英医疗激光有限责任公司、上海晟昶光电技术有限公司、天津市雷意激光技术有限公司、中国计量大学

Drafting Persons:

李敏、杜堃、邵建华、潘大光、刘宏梅、黄杰、方春子、陈义、黄丹、孙瑜、赵祥瑞

Word Count: 15 Thousand words Pages: 7 pages

Replace the following standards

GB 12257-2000 General specification of He-Ne Laser medical equipment

Referenced Standards

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 9706.222-2022 Medical electrical equipment—Part 2-22:Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment YY/T 0758-2009 General requirements for therapeutic laser fiber YY/T 0758-2021 General requirements for medical laser fiber YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests

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