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www.ChineseStandard.net Database: 189760 (25 Oct 2025)

YY 0898-2013 English PDF

US$359.00 · In stock
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YY 0898-2013: Millimeter wave therapy equipment
Status: Obsolete

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY 0898-2013	English	359	Add to Cart	3 days [Need to translate]	Millimeter wave therapy equipment	Obsolete	YY 0898-2013

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Basic data

Standard ID	YY 0898-2013 (YY0898-2013)
Description (Translated English)	Millimeter wave therapy equipment
Sector / Industry	Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard	C42
Classification of International Standard	11.040.60
Word Count Estimation	9,997
Quoted Standard	GB/T 191; GB 9706.1-2007; GB 9706.15; GB/T 14710; YY/T 0466.1; YY 0505
Regulation (derived from)	State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the definition of millimeter wave therapy equipment, classification, requirements, test methods, marking, manual, packaging, transportation and storage. 3. 1 This standard applies to the definition of a non-thermal effects of the t

YY 0898-2013: Millimeter wave 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.
Millimeter wave therapy equipment ICS 11.040.60 C42 People's Republic of China pharmaceutical industry standards Millimeter wave therapy equipment Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard is based on the technical requirements needed to determine the clinical and electrical safety requirements of comprehensive implementation of the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety. " The standards for electromagnetic compatibility requirements YY 0505 "Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. electric Magnetic compatibility - Requirements and tests "be implemented. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. As used in the form of material or structure is different from the equipment or components specified in this standard can prove that they achieve the same degree of safety, should be It is recognized. This standard was proposed by the China Food and Drug Administration. This standard by the National Technical Committee of Standardization for medical electrical physical therapy equipment at the Technical Committee (SAC/TC10/SC4) centralized. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Chinese Academy of Medical Sciences Biological Institute of Biomedical Engineering. The main drafters of this standard. Qili Jing, Yin Tao, Yang Juan, Liu Zhipeng, Duan Qiao Feng, Zhang Haiming. Millimeter wave therapy equipment

1 Scope

This standard specifies the definition of millimeter wave therapy equipment, classification, requirements, test methods, marking, instructions, packaging, transportation and storage. 3.1 This standard applies to the definition of a non-thermal effects of the treatment of diseases millimeter wave therapy equipment (hereinafter referred to as the device).

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 191 Packaging - Pictorial signs GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety GB 9706.15 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard. Safety requirements for medical electrical systems GB/T 14710 medical electrical environmental requirements and test methods Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements YY 0505 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests

3 Definitions

GB 9706.1-2007 defined and the following terms and definitions apply to this document. 3.1 Millimeter wave therapy equipment milimeterwavestherapyequipment Use 30GHz ~ 300GHz (wavelength 1mm ~ 10mm) band electromagnetic wave radiation exposure by way of non-thermal effects of treatment Medical equipment disease. 3.2 Radiator radiator Radiation, i.e. there is a directional antenna. For example, the horn antenna used for patients with localized millimeter wave energy device is applied annex. 3.3 Application Part appliedpart Accessible part of the radiator and transmission lines connected thereto. 3.4 Rated output power density ratedoutputpowerdensity The radiator output per unit area measured maximum power average.

4 Composition

Usually by the host equipment, radiators (directional radiation antenna) and the connecting cable.

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