YY 0898-2013Millimeter wave therapy equipment (English PDF)
毫米波治疗设备
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY 0898-2013 is the English-translated version of 毫米波治疗设备.
YY 0898-2013 is the Chinese pharmaceutical industry standard for millimetre wave therapy equipment, the device that treats disease by the non-thermal effect of millimetre waves.
It specifies the definitions, the classification, the requirements, the test methods, the marking, the instructions and the rules for packaging, transport and storage, covering the output frequency and power density and their accuracy, the applicator and the treatment distance, the timer, the leakage radiation and the electrical safety. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY 0898-2013
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C 42
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Definitions
- 4 Composition
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.
1 Scope
This standard specifies the definition of millimeter wave therapy equipment, classification, requirements, test methods, marking, instructions, packaging, transportation and storage.
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
Use 30GHz ~ 300GHz (wavelength 1mm ~ 10mm) band electromagnetic wave radiation exposure by way of non-thermal effects of treatment Medical equipment disease.
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).
3.2 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
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.15Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- YY 0505Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
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Related Standards
GB 9706.15-2008 — Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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YY 0898-2013
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