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
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
