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GB/T 12257-2023: Laser therapeutic equipment - He-Ne laser equipment
Status: Valid GB/T 12257: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 12257-2023 | English | 179 |
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3 days [Need to translate]
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Laser therapeutic equipment - He-Ne laser equipment
| Valid |
GB/T 12257-2023
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| GB 12257-2000 | English | 399 |
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3 days [Need to translate]
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General specification of He-Ne laser medical equipment
| Obsolete |
GB 12257-2000
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| GB 12257-1990 | English | RFQ |
ASK
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3 days [Need to translate]
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The general specification of He-Ne laser device
| Obsolete |
GB 12257-1990
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PDF similar to GB/T 12257-2023
Standard similar to GB/T 12257-2023 GB 9706.237 GB 9706.4 GB 10152 GB/T 11748 Basic data | Standard ID | GB/T 12257-2023 (GB/T12257-2023) | | Description (Translated English) | Laser therapeutic equipment - He-Ne laser equipment | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 8,850 | | Date of Issue | 2023-05-23 | | Date of Implementation | 2024-06-01 | | Older Standard (superseded by this standard) | GB 12257-2000 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 12257-2023: Laser therapeutic equipment - He-Ne 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 12257-2000
Laser therapy equipment He-Ne laser therapy machine
Released on 2023-05-23
2024-06-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
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 12257-2000 "General Technical Conditions for He-Ne Laser Therapy Machines":
In addition to rectification and editorial changes, the main technical changes are as follows:
---Changed the scope of application of the standard (see Chapter 1, Chapter 1 of the:2000 edition);
--- Deleted terms and definitions (see Chapter 3 of the:2000 edition);
--- Deleted product composition and basic parameters (see Chapter 4 of the:2000 edition);
--- Added "laser peak wavelength" (see 4:2:1);
--- Changed the "laser mode" (see 4:2:2, 5:2:2 of the:2000 edition);
--- Changed the "laser terminal output power" (see 4:2:3, 5:2:1, 5:6, 5:7 of the:2000 edition);
--- Added "laser output mode and its time characteristics" (see 4:2:6);
--- Added "the exposure limit of the treatment machine" (see 4:2:7);
--- Added "aiming system (if applicable)" (see 4:3);
--- Added "transmission system" (see 4:4, 5:8 of the:2000 edition);
--- Changed the "timing device" (see 4:5, 5:5 of the:2000 edition);
--- Added "Laser safety goggles (if applicable)" (see 4:6);
--- Changed "Security" (see 4:7, 5:9, 5:10, 5:11 of the:2000 edition);
--- Added "electromagnetic compatibility" (see 4:8);
--- Changed the "environmental adaptability" (see 4:9, 5:15 of the:2000 edition);
--- Deleted "marks and files" (see Section 5:11 of the:2000 edition);
--- Deleted "painted parts" (see 5:12 of the:2000 edition);
--- Deleted "electroplated parts" (see 5:13 of the:2000 edition);
--- Deleted "aluminum parts" (see 5:14 of the:2000 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, Jilin Keying Medical Laser Co:, Ltd:, Shanghai Shengchang Optoelectronics Co:, Ltd:
Technology Co:, Ltd:, Tianjin Leiyi Laser Technology Co:, Ltd:, China Jiliang University:
The main drafters of this document: Li Min, Du Kun, Shao Jianhua, Pan Daguang, Liu Hongmei, Huang Jie, Fang Chunzi, Chen Yi, Huang Dan, Sun Yu, Zhao Xiangrui:
The release status of previous versions of this document and the documents it replaces are as follows:
---First published in:1990 as GB 12257-1990, first revised in:2000;
--- This is the second revision:
Laser therapy equipment He-Ne laser therapy machine
1 Scope
This document specifies the requirements and test methods for helium-neon laser therapy machines:
This document is applicable to the helium-neon laser treatment machine (hereinafter referred to as the treatment machine) with a wavelength of 632:8nm for human body irradiation:
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 7247:1-2012 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
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
This document does not have terms and definitions that need to be defined:
4 requirements
4:1 Normal working conditions
The manufacturer shall at least specify the following normal operating condition parameters:
--- ambient temperature;
---Relative humidity;
---using electric:
4:2 Therapeutic Lasers
4:2:1 Laser peak wavelength
632:8nm±10nm:
4:2:2 Laser mode
Fundamental or higher-order modules:
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 12257-2023_English be delivered?Answer: Upon your order, we will start to translate GB/T 12257-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of GB/T 12257-2023_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 12257-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. Question 5: Should I purchase the latest version GB/T 12257-2023?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 12257-2023 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.
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