GB/T 5295-1985
Replaced
YY/T 0758-2021
Active
Industry standards-Medicine
YY/T 0758-2021 General requirements for medical laser fiber
YY/T 0758-2021 General requirements for medical laser fiber
Basic Information
Standard Code:
YY/T 0758-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Optoelectronics, laser equipment
Publish Date:
2021-09-06
Implement Date:
2022-09-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用光学和仪器标准化分技术委员会(SAC/TC 103/SC 1)
Pages:
13 pages
Scope
本标准规定了医用激光光纤的通用要求。
本标准适用于传输激光的医用激光光纤(以下简称:光纤)。
本标准不适用于具有增益功能的光纤。
如果光纤构成设备的一部分,且不能从设备上移开,则设备必须遵从相关国家标准(如GB 9706.1,GB 9706.20,GB 7247.1等),并参考执行本标准。然而,如果光纤可以从设备移开,则被移开的单元应符合本标准的适用要求。
Development Information
Drafting Units:
浙江省医疗器械检验研究院
Drafting Persons:
黄丹、李敏、杜堃、方春子、孙瑜、秦丽平
Replace the following standards
Referenced Standards
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
ISO 11146(所有部分)
中华人民共和国药典2020版
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 9706.19-2000 Medical electrical equipment—Part 2:Particular requirements for the safety of endoscopic equipment
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
YY/T 0313-1998 Package,lable,transport and storage for medical polymer products
YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer
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
Related Standards
GB/T 7257-1987
Replaced
GB/T 7257-1987 Measurement methods of parameter for helium neon laser
GB/T 7270-1987
Replaced
GB/T 7270-1987 Methods of measurement for photomultiplier tubes
GB/T 7271-1987
Abolished
GB/T 7271-1987 Methods of measurement for phototubes
GB/T 12082-1989
Active
GB/T 12082-1989 Letter symbols for gas lasers
GB/T 12083-1989
Replaced