YY/T 0323-2024 English PDFUS$159.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0323-2024: Infrared ray cauterization therapy equipment Status: Valid YY/T 0323: Historical versions
Basic dataStandard 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11.040.60 Word Count Estimation: 7,793 Date of Issue: 2024-02-07 Date of Implementation: 2025-03-01 Older Standard (superseded by this standard): YY 0323-2018 Issuing agency(ies): State Drug Administration Summary: This standard specifies the requirements for infrared thermal therapy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 ContentsPreface 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 3ForewordThis 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 equipment1 ScopeThis 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 referencesThe 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 equipment3 Terms and definitionsThe 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 Requirements4.1 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0323-2024_English be delivered?Answer: Upon your order, we will start to translate YY/T 0323-2024_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 YY/T 0323-2024_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0323-2024_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 Sales@ChineseStandard.net. 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 YY/T 0323-2024?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0323-2024 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. |
