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YY/T 0323-2024: Infrared ray cauterization therapy equipment
Status: Valid YY/T 0323: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0323-2024 | English | 159 |
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3 days [Need to translate]
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Infrared ray cauterization therapy equipment
| Valid |
YY/T 0323-2024
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| YY 0323-2018 | English | 179 |
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3 days [Need to translate]
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Particular requirements for the safety of infrared therapy equipment
| Valid |
YY 0323-2018
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| YY 0323-2008 | English | 239 |
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Particular requirements for the safety of infrared therapy equipment
| Obsolete |
YY 0323-2008
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| YY 0323-2000 | English | 239 |
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2 days [Need to translate]
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Particular requirements for the safety of infrared therapy equipment
| Obsolete |
YY 0323-2000
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PDF similar to YY/T 0323-2024
Standard similar to YY/T 0323-2024 YY 0778 YY 0950 YY 0903 YY/T 0324 YY/T 0322 Basic data | Standard ID | YY/T 0323-2024 (YY/T0323-2024) | | Description (Translated English) | Infrared ray cauterization therapy equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 7,793 | | Date of Issue | 2024-02-07 | | Date of Implementation | 2025-03-01 | | Older Standard (superseded by this standard) | YY 0323-2018 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the requirements for infrared thermal therapy equipment and describes the corresponding test methods. This document applies to infrared thermal cautery therapy equipment. This document does not apply to infrared laser therapy equipment. | YY/T 0323-2024: Infrared ray cauterization therapy 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
CCSC42
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0323-2018
Infrared heat therapy equipment
Released on 2024-02-07
2025-03-01 Implementation
The State Drug Administration issued
Table of Contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Output Power 1
4.2 Output Control 2
4.3 Timing device 2
4.4 Mark 2
4.5 Attached Documents 2
4.6 Electrical safety 2
4.7 Environmental test 2
4.8 Electromagnetic compatibility 2
4.9 Requirements for LS equipment 3
5 Test methods 3
5.1 Output power 3
5.2 Output Control 3
5.3 Timing device 3
5.4 Mark 3
5.5 Attached Documents 3
5.6 Electrical safety 3
5.7 Environmental test 3
5.8 Electromagnetic compatibility 3
5.9 Requirements for LS equipment 3
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 YY 0323-2018 "Special Safety Requirements for Infrared Therapy Equipment". Compared with YY 0323-2018, in addition to structural adjustments
In addition to editorial changes, the main technical changes are as follows.
--- Changed the terms and definitions of infrared thermal therapy equipment and irradiation gun (see 3.1, 3.2, 2.1.101, 2.1.102 of the.2018 edition);
--- Added terms and definitions of light source equipment (see 3.3);
--- Deleted the application part of terms and definitions (see 2.1.5 of the.2018 edition);
--- Changed the timing deviation of the timing device (see 4.3, 51.103 of the.2018 edition);
--- Changed the requirements for accompanying documents (see 4.5, 6.8.2 of the.2018 edition);
--- Added environmental test requirements and test methods (see 4.7, 5.7);
--- Added requirements and test methods for LS equipment (see 4.9, 5.9);
--- Deleted the requirements for classification (see Chapter 14 of the.2018 edition);
--- Deleted the requirements for castors (see 24.101 of the.2018 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the Physical Therapy Equipment Subcommittee of the National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC10/SC4).
This document was drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Henan Xiangyu Medical Equipment Co., Ltd., Liaoning Provincial Medical
Medical device inspection and testing institute.
The main drafters of this document are. Yang Guojuan, Qian Xuebo, Pan Dongping, Wang Bo, He Yongzheng and Li Fei.
The previous versions of the standards replaced by this document are as follows.
---First issued in.2000 as YY 0323-2000, first revised in.2008, and second revised in.2018;
---This is the third revision.
Infrared heat therapy equipment
1 Scope
This document specifies the requirements for infrared thermotherapy equipment (hereinafter referred to as "equipment") and describes the corresponding test methods.
This document applies to infrared thermal therapy equipment.
This document does not apply to infrared laser therapy equipment.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 5465.2-2008 Graphical symbols for electrical equipment Part 2.Graphical symbols
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and essential performance
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility
Requirements and tests
YY 9706.257 Medical electrical equipment Part 2-57.Non-laser light sources for treatment, diagnosis, monitoring and plastic surgery/cosmetology
Particular requirements for basic safety and essential performance of equipment
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Using the thermal effect of infrared radiation, the irradiated tissue undergoes denaturation and/or coagulation in a short period of time.
Equipment used to treat patients.
3.2
Lightup gun
A component used to output infrared radiation.
3.3
Light source equipment (LS equipment) lightsourceequipment
Contains one or more non-laser optical radiation sources with a wavelength range of.200nm~3000nm, which produce non-visible
Medical electrical devices for therapeutic, diagnostic, monitoring, plastic/cosmetic or veterinary applications.
[Source. YY 9706.257-2021,.201.3.208]
4 Requirements
4.1 Output Power
4.1.1 The output power may be indicated in absolute or relative units. For relative indication, do not use units that may differ from the actual output power.
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