YY/T 1490-2016Electric heating moxibustion equipment (English PDF)
电子加热灸疗设备
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1490-2016 is the English-translated version of 电子加热灸疗设备.
YY/T 1490-2016 is the Chinese pharmaceutical industry standard for electric heating moxibustion equipment, the device that reproduces the warmth of moxibustion with an electrically heated head.
It specifies the terms and definitions, the composition, the requirements, the test methods, the inspection rules, the marking and the rules for packaging, transport and storage, covering the temperature reached at the treatment head and its accuracy and uniformity, the protection against overheating and burns, the timer, the materials in contact with the skin and the electrical safety. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1490-2016
National Standard of the People's Republic of China
- Classification
- C 42
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 normative reference document
- 3 Terms and definitions
- 4 Composition
- 5 request
- 6 Test Method
- 7 Inspection rules
- 8 logo, label, instruction manual
- 9 Packaging, transportation and storage
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marking, packaging, and transportation of electronic heating moxibustion equipment And storage.
This standard applies to the electronic heating moxibustion equipment (hereinafter referred to as "equipment") as defined in 3.1. For a multi-functional device, this standard Of the provisions of the provisions of the equipment only applies to the moxibustion function, other functions such as the corresponding national standards and/or industry standards, should also meet other Requirements for relevant standards.
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191-2008 Packaging and storage icon (ISO 780.:1997, MOD)
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety Claim Environmental requirements and test methods for medical appliances GB/T 14710-2009
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1.:2009, IDT)
Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009 (ISO 15223-1.:2007, IDT)
YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2.:2004, IDT)
3 Terms and definitions
GB 9706.1-2007 and the following terms and definitions apply to this document.
3.1 Electric heating moxibustion equipment
The use of electronic devices fever principle, the moxibustion pad for heating, moxibustion in the human body acupuncture points or specific parts of the equipment.
3.2 Moxibutionhead
For the application of hot moxibustion in patients with part of the shell and heating body composition.
3.3 Moxibustion
Moxibustion head heat and body contact with the media, also known as the insulation pad.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191-2008Graphical 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 9706.15-2008Medical electrical equipment -- Part 1: General requirements for safety. 1 -- Collateral standard: Safety requirements for medical electrical systems
- GB/T 16886.1-2011Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY 0505-2012Medical 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
YY 0505-2012 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1490-2016
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