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YY/T 0757-2009: Guidelines for the safe use of laser beams on humans
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0757-2009 | English | 634 |
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Guidelines for the safe use of laser beams on humans
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YY/T 0757-2009
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Standard similar to YY/T 0757-2009 YY/T 0758 YY/T 0719.8 YY 0762 YY 0792 Basic data | Standard ID | YY/T 0757-2009 (YY/T0757-2009) | | Description (Translated English) | Guidelines for the safe use of laser beams on humans | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 31.260; 11.040.99 | | Word Count Estimation | 32,349 | | Date of Issue | 2009-11-15 | | Date of Implementation | 2010-12-01 | | Adopted Standard | IEC/TR 60825-8-2006, IDT | | Regulation (derived from) | Industry standard filing Notice 2010 No. 2 (No. 122 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to a given laser equipment owner, responsible agencies, laser safety officer, laser equipment operators and other stakeholders on how to safely use Class 3B or Class 4 lasers and laser equipment to provide guidance. Include at least the scope of this standard in health care, beauty and hair removal centers, dental clinics, but also in transportation, homes laser beam acting on the body in all applications. This standard provides for the patient, operation, maintenance personnel have control of the security measures. Also laser equipment or devices that belong to a part of engineering controls are briefly introduced in order to make everyone understand its general protection principles. The scope of this standard include: beam delivery system, biological effects of laser radiation, report accidents and hazardous situations, lists. | YY/T 0757-2009: Guidelines for the safe use of laser beams on humans---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Guidelines for the safe use of laser beams on humans
ICS 31.260; 11.040.99
C40
People's Republic of China pharmaceutical industry standards
YY/T 0757-2009/IEC /TR60825-8.2006
Human security using the laser beam guide
(IEC /T R60825-8.2006, Safetyoflaserproducts-
Part 8. Guidelinesforthesafeuseoflaserbeamsonhumans, IDT)
Posted 2009-11-15
2010-12-01 implementation
State Food and Drug Administration issued
Table of Contents
Preface Ⅰ
Introduction Ⅱ
1 Scope and Purpose 1
2 Normative references 1
3 Terms and definitions
4 hazards, objectives and control measures 3
Risk 4.1 pairs of eyes 3
Risk 4.2 pairs skin 4
Fire and burn hazards 4.3 of 5
4.4 toxic gases, smoke and vapor 6
4.5 With the hazards 6
5 7 manager
5.1 Laser Safety Officer (LSO) 7
5.2 medical supervision (ophthalmology monitor) 7
5.3 incident and accident reports 8
9 5.4 Maintenance and Inspection
6 Training Recommendation 9
Environment 7 laser devices 9
7.1 laser controlled area 9
7.2 Windows 10
7.3 Walls 10
7.4 Fire 10
Technical Information Appendix A (informative) biological effects, hazards, 11 laser equipment
Annex B (informative) shielding windows 16
Checklist Appendix C (informative) laser equipment installed 17
Annex D (informative) 20 laser safety training
Annex E (informative) inspection schedule 21
Annex F (informative) laser device applications in security issues 24
References 27
Table A. List of pathological excess lighting effect 1 11
Table E. 1 Checklist 22
YY/T 0757-2009/IEC /TR60825-8.2006
Foreword
This standard is equivalent to international standards IEC /T R60825-8.2006 "Safety of laser products - Part 8. human safety laser beam
Guide. "
This standard Appendices A to F are informative appendices.
This standard by the National Optics and optical instruments optical and medical instruments Standardization Technical Committee (SAC/TC103/SC1) and proposed
Centralized.
This standard was drafted by the State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Han Jian City, Ye Yueshun, Sun Yu, Du .
YY/T 0757-2009/IEC /TR60825-8.2006
Introduction
Laser equipment can emit visible and (or) non-visible light radiation. In some cases, the radiation is a parallel beam, almost no hair
Scattered. That is to say, a long distance, the laser can maintain its inherent high irradiance. Therefore, the laser beam can be focused to a very small
Area, and it may be dangerous to the eyes or skin. Appendix A of the laser system and its medical applications do some explanation.
Laser work during any related person may be susceptible to laser damage. Lack of protective measures, the use of the defective laser equipment,
Misdirected or inappropriate laser beam laser control device can lead to a higher risk of injury (especially for the eyes), and (or) bring
Other adverse effects.
The purpose of this guide is to provide guidance on how to ensure their safety in the practice of medicine in the laser.
Although the laser equipment operator for the use of laser equipment are directly responsible for the safety, laser equipment owners also bear the establishment of the safe
Accountability framework of the system used. This guide is strongly recommended to appoint a laser safety officer for the owner and the laser equipment and laser equipment operation
Provide professional advice for all personnel-related. The guidelines emphasize the need to provide appropriate laser safety training for all staff, including
Including providing installation, operation, maintenance and repair of the Practical Guide.
YY/T 0757-2009/IEC /TR60825-8.2006
Human security using the laser beam guide
1 Scope and Purpose
This standard is to be used as a laser device owner, responsible agencies, laser safety officer, laser equipment operators and other stakeholders, to
Safe use guidelines Class 3B or Class 4 laser and laser equipment provided. The scope of the standard includes at least in health care,
Beauty & hair removal centers, dental clinics, including all applications in vehicles, homes laser beam is applied to the human body.
Note. Although the above range does not include the classification level is lower than Class 3B or Class 4 laser equipment, it should be pointed out. the use of laser energy level lower than Class 3B
Or 4 emission limits of laser equipment and protective response when individuals fail or missing, still need special attention.
This standard describes the control measures for patients, operators, maintenance personnel safety recommendations. Meanwhile, also on the part of the laser
Engineering controls a part of the equipment or devices have been introduced, so that we understand the general protection principles.
The scope of the standard includes.
--- Beam delivery system;
--- Biological effects of laser radiation;
--- Reporting of accidents and dangerous situations;
--- List.
The purpose of this standard is to establish security procedures by providing a how to guide prevention and control measures for the user, so that to better protect
Laser radiation and other hazards.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequently
Some amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Study whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
no.
3 Terms and Definitions
The following terms and definitions apply to this standard.
Note. The reference terms and definitions GB 7247.1-2001 and GB 9706.20-2000 in.
3.1
Patient and (or) other unforeseen circumstances cause injury.
3.2
Avoid noxious stimuli motion or light eyelids or head.
Note. For visible lasers, will assume a protective response occurs within 0.25s.
3.3
It is used to transmit the laser beam to the target area, and the laser beam can be focused so that it can be manipulated or forming optical system.
Note 1. Examples of beam delivery system comprises an optical fiber, hand-held part, micromanipulator and a scanning device.
Note 2. See also GB 9706.20-2000 of 2.1.106.
YY/T 0757-2009/IEC /TR60825-8.2006
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