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YY/T 0758-2021   General requirements for medical laser fiber (English Version)
Standard No.: YY/T 0758-2021 Status:valid remind me the status change

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Language:English File Format:PDF
Word Count: 7500 words Price(USD):225.0 remind me the price change

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Implemented on:2022-9-1 Delivery: via email in 1 business day
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Standard No.: YY/T 0758-2021
English Name: General requirements for medical laser fiber
Chinese Name: 医用激光光纤通用要求
Professional Classification: YY    Professional Standard - Pharmaceutics
Issued by: National Medical Products Adminstration
Issued on: 2021-09-06
Implemented on: 2022-9-1
Status: valid
Superseding:YY/T 0758-2009 General requirements for therapeutic laser fiber
Language: English
File Format: PDF
Word Count: 7500 words
Price(USD): 225.0
Delivery: via email in 1 business day
General requirements for medical laser fiber 1 Scope This standard specifies the general requirements for medical laser fibers. This standard is applicable to medical laser fibers (hereinafter referred to as "fibers") designed for transmitting laser. This standard is not applicable to fibers with gain capabilities. If the fiber is an integral part of a device and cannot be detached from it, the device must comply with relevant national standards (such as GB 9706.1, GB 9706.20, GB 7247.1, etc.) and adhere to this standard. However, if the fiber may be detached from the device, the detached unit shall comply with the applicable requirements of this standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance GB 9706.19 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process YY/T 0313 Medical polymer products - Requirement for package and information supplied by manufacturer YY 9706.102 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests ISO 11146 (all parts) Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios Pharmacopoeia of the People's Republic of China (Edition 2020)   3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 medical laser fiber product that utilizes fiber as the propagation medium to transmit laser energy 3.2 fiber applicator application component made directly from the end of an optical fiber cable 3.3 additional applicator application component connected to the end of the optical fiber cable Note: Examples include handpieces, microcontrollers, etc. 3.4 optical fiber cable the portion of a fiber used for laser transmission, typically consisting of a fiber core, cladding, and coating layers Note: The coating layers include buffer layer and protective layer. 3.5 connector device used to connect the fiber to laser equipment 3.6 tensile strength maximum tensile force that a material can withstand 4 Structural composition and classification
Foreword I 1 Scope 2 Normative references 3 Terms and definitions 4 Structural composition and classification 5 Requirements 6 Test methods 7 Packaging, marking, instructions for use, transportation and storage
Referred in YY/T 0758-2021:
*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 14233.1-2008 Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods
*GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
*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
Code of China
Standard
YY/T 0758-2021  General requirements for medical laser fiber (English Version)
Standard No.YY/T 0758-2021
Statusvalid
LanguageEnglish
File FormatPDF
Word Count7500 words
Price(USD)225.0
Implemented on2022-9-1
Deliveryvia email in 1 business day
Detail of YY/T 0758-2021
Standard No.
YY/T 0758-2021
English Name
General requirements for medical laser fiber
Chinese Name
医用激光光纤通用要求
Chinese Classification
Professional Classification
YY
ICS Classification
Issued by
National Medical Products Adminstration
Issued on
2021-09-06
Implemented on
2022-9-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
YY/T 0758-2009 General requirements for therapeutic laser fiber
Language
English
File Format
PDF
Word Count
7500 words
Price(USD)
225.0
Keywords
YY/T 0758-2021, YY 0758-2021, YYT 0758-2021, YY/T0758-2021, YY/T 0758, YY/T0758, YY0758-2021, YY 0758, YY0758, YYT0758-2021, YYT 0758, YYT0758
Introduction of YY/T 0758-2021
General requirements for medical laser fiber 1 Scope This standard specifies the general requirements for medical laser fibers. This standard is applicable to medical laser fibers (hereinafter referred to as "fibers") designed for transmitting laser. This standard is not applicable to fibers with gain capabilities. If the fiber is an integral part of a device and cannot be detached from it, the device must comply with relevant national standards (such as GB 9706.1, GB 9706.20, GB 7247.1, etc.) and adhere to this standard. However, if the fiber may be detached from the device, the detached unit shall comply with the applicable requirements of this standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance GB 9706.19 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process YY/T 0313 Medical polymer products - Requirement for package and information supplied by manufacturer YY 9706.102 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests ISO 11146 (all parts) Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios Pharmacopoeia of the People's Republic of China (Edition 2020)   3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 medical laser fiber product that utilizes fiber as the propagation medium to transmit laser energy 3.2 fiber applicator application component made directly from the end of an optical fiber cable 3.3 additional applicator application component connected to the end of the optical fiber cable Note: Examples include handpieces, microcontrollers, etc. 3.4 optical fiber cable the portion of a fiber used for laser transmission, typically consisting of a fiber core, cladding, and coating layers Note: The coating layers include buffer layer and protective layer. 3.5 connector device used to connect the fiber to laser equipment 3.6 tensile strength maximum tensile force that a material can withstand 4 Structural composition and classification
Contents of YY/T 0758-2021
Foreword I 1 Scope 2 Normative references 3 Terms and definitions 4 Structural composition and classification 5 Requirements 6 Test methods 7 Packaging, marking, instructions for use, transportation and storage
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