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GB/T 11748-2023: Laser therapeutic equipment - Carbon dioxide laser equipment
Status: Valid
GB/T 11748: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 11748-2023 | English | 279 |
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3 days [Need to translate]
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Laser therapeutic equipment - Carbon dioxide laser equipment
| Valid |
GB/T 11748-2023
|
| GB 11748-2005 | English | 1039 |
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5 days [Need to translate]
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Carbon dioxide laser treating instrument
| Obsolete |
GB 11748-2005
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| GB 11748-1999 | English | 559 |
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4 days [Need to translate]
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Carbon dioxide laser treating instrument
| Obsolete |
GB 11748-1999
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| GB 11748-1989 | English | RFQ |
ASK
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3 days [Need to translate]
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CO2 laser treating instrument
| Obsolete |
GB 11748-1989
|
PDF similar to GB/T 11748-2023
Basic data
| Standard ID | GB/T 11748-2023 (GB/T11748-2023) |
| Description (Translated English) | Laser therapeutic equipment - Carbon dioxide laser equipment |
| Sector / Industry | National Standard (Recommended) |
| Classification of Chinese Standard | C41 |
| Classification of International Standard | 11.040.60 |
| Word Count Estimation | 13,112 |
| Date of Issue | 2023-05-23 |
| Date of Implementation | 2024-06-01 |
| Older Standard (superseded by this standard) | GB 11748-2005 |
| Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration |
GB/T 11748-2023: Laser therapeutic equipment - Carbon dioxide laser equipment
---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.
ICS 11:040:60
CCSC41
National Standards of People's Republic of China
Replacing GB 11748-2005
Laser Therapy Equipment CO2 Laser Therapy Machine
Released on 2023-05-23
2024-06-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Structural composition and product classification 2
5 requirements 4
6 Test method 6
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents"
drafting:
This document replaces GB 11748-2005 "Carbon dioxide laser therapy machine": Compared with GB 11748-2005, except for structural adjustment and editing
In addition to sexual changes, the main technical changes are as follows:
---Changed the scope of application of the standard (see Chapter 1, Chapter 1 of the:2005 edition);
--- Changed the terms and definitions (see Chapter 3, Chapter 3 of the:2005 edition);
--- Changed the structural composition and product classification (see Chapter 4, Chapter 4 of the:2005 edition);
---Deleted "treatment machine working conditions" (see 5:1 of the:2005 edition);
--- Changed the "laser wavelength" (see 5:1:1, 5:2:1 of the:2005 edition);
--- Changed the "laser mode" (see 5:1:2, 5:2:2 of the:2005 edition);
--- Added "laser output mode and its time characteristics" (see 5:1:3);
--- Changed the "terminal output laser power or energy" (see 5:1:4, 5:3 of the:2005 edition);
---Changed the "laser terminal output power/energy instability" (see 5:1:5, 5:4 of the:2005 edition);
---Changed the "laser terminal output power/energy reproducibility" (see 5:1:6, 5:5 of the:2005 edition);
---Changed the "facula parameters of the treatment surface" (see 5:1:7, 5:2:3 of the:2005 edition);
---Changed the "aiming system" and "transmission system" (see 5:2, 5:3, 5:6 of the:2005 edition);
--- Deleted "laser power supply and control device requirements" (see 5:7 of the:2005 edition);
--- Changed the "cooling system" (see 5:4, 5:8 of the:2005 edition);
--- Deleted "appearance" (see 5:9 of the:2005 edition);
--- Added "laser protective glasses" (see 5:5);
--- Added "foot switch" (see 5:6);
--- Changed the "environmental adaptability" (see 5:9, 5:11 of the:2005 edition);
--- Added "electromagnetic compatibility" (see 5:8);
--- Changed "Security" (see 5:7, 5:10 of the:2005 edition);
--- Deleted "inspection rules" (see Chapter 7 of the:2005 edition);
--- Deleted "marking, packaging, transportation, storage" (see Chapter 8 of the:2005 edition);
--- Deleted "Other" (see Chapter 9 of the:2005 edition);
--- Deleted "Security" (see Appendix A of the:2005 edition):
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed and managed by the State Drug Administration:
This document was drafted by: Zhejiang Institute of Medical Device Inspection, Keyiren Laser Technology (Beijing) Co:, Ltd:, Wuhan Qizhi Laser Technology Co:, Ltd:
Technology Co:, Ltd:, Shanghai Laser Technology Research Institute:
The main drafters of this document: Li Min, Du Kun, Zhao Ming, Zhou Jiang, Wang Caixia, Fang Chunzi, Huang Dan, Su Yuan, Qin Liping, Li Wen, Xia Zhongzhong:
The release status of previous versions of this document and the documents it replaces are as follows:
---First published in:1999 as GB 11748-1999, first revised in:2005;
--- This is the second revision:
Laser Therapy Equipment CO2 Laser Therapy Machine
1 Scope
This document specifies the terms and definitions, structural composition, product classification, requirements and test methods of carbon dioxide laser therapy machines:
This document is applicable to carbon dioxide laser treatment machines with an output wavelength of 9 μm to 11 μm (hereinafter referred to as treatment machines):
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document:
GB 7247:1 Safety of Laser Products Part 1: Equipment Classification and Requirements
GB 9706:1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
GB 9706:222 Medical electrical equipment Part 2-22: Basic safety and fundamentals of surgical, orthopedic, therapeutic and diagnostic laser equipment
Specific requirements for this performance
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
YY/T 0758 General Requirements for Medical Laser Optical Fibers
YY/T 1057 General Technical Specifications for Medical Foot Switches
YY9706:102 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
Content requirements and tests
3 Terms and Definitions
The following terms and definitions apply to this document:
3:1
50% pulse width 50%-pulseduration
τ50
The time interval between a laser pulse rising and falling to its 50% peak power point, see Figure 1:
3:2
10% pulse width 10%-pulseduration
τ10
The time interval between a laser pulse rising and falling to its 10% peak power point, see Figure 1:
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Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 11748-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.