GB/T 11748-2023 Active National standards

GB/T 11748-2023 Laser therapeutic equipment—Carbon dioxide 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 11748-2023

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: 12 pages

Scope

本文件规定了二氧化碳激光治疗机的术语和定义、结构组成、产品分类、要求和试验方法。本文件适用于输出波长为9 μm～11 μm的二氧化碳激光治疗机（以下简称治疗机)。

Development Information

Drafting Units:

浙江省医疗器械检验研究院、科医人激光科技(北京)有限公司、武汉奇致激光技术股份有限公司、上海市激光技术研究所

Drafting Persons:

李敏、杜堃、赵鸣、周江、王彩霞、方春子、黄丹、苏源、秦丽平、李雯、夏忠诚

Word Count: 25 Thousand words Pages: 12 pages

Replace the following standards

GB 11748-2005 Carbon dioxide laser treating instrument

Referenced Standards

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 9706.222-2022 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/T 1057-2016 General specifications for medical foot switch 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 GB/T 7247.1-2024 Safety of laser products—Part1:Equipment classification and requirements YY 1057-2016 General specifications for medical foot switch

Related Standards

GB 12259-1990 Abolished

GB 12259-1990 Artificial heart-lung machine

Publish Date: 1990-01-08

GB 12261-1990 Abolished

GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator

Publish Date: 1990-01-08

GB 12262-1990 Abolished

GB 12262-1990 Artificial heart-lung machine—Heat exchanger

Publish Date: 1990-01-08

GB 2024-1994 Replaced

GB 2024-1994 Acupuncture needles

Publish Date: 1994-04-12

GB 10035-1994 Replaced

GB 10035-1994 The air-bag type sequential external counter-pulsation device

Publish Date: 1994-07-06

GB 16174.1-1996 Replaced

GB 16174.1-1996 Cardiac pacemakers—Part 1:Implantable pacemakers

Publish Date: 1996-03-07