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US$199.00 ยท In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1490-2016: Electric heating moxibustion equipment Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1490-2016 | English | 199 |
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Electric heating moxibustion equipment
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YY/T 1490-2016
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Basic data | Standard ID | YY/T 1490-2016 (YY/T1490-2016) | | Description (Translated English) | Electric heating moxibustion equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Word Count Estimation | 10,156 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Quoted Standard | GB/T 191-2008; GB 9706.1-2007; GB 9706.15-2008; GB/T 14710-2009; GB/T 16886.1-2011; YY/T 0466.1-2009; YY 0505-2012 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marking, packaging, transportation and storage of electronic heating moxibustion equipment. This standard applies to the electronic heating moxibustion equipment (hereinafter referred to as the device) as defined in 3.1. For a multifunctional device, the provisions of this standard apply only to the moxibustion function of the device, other functions such as the corresponding national standards and/or industry standards, should also meet the requirements of other relevant standards. |
YY/T 1490-2016: Electric heating moxibustion 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.
Electric heating moxibustion equipment
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Electronic heating moxibustion equipment
2016-07-29 released
2017-06-01 implementation
State Food and Drug Administration issued
Directory
Preface I
1 Scope 1
2 normative reference document 1
3 Terms and definitions 1
4 Composition 2
5 request 2
6 Test Method 3
7 Inspection rules 4
8 logo, label, instruction manual 5
9 Packaging, transportation and storage 6
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Electrical Apparatus Standardization Technical Committee of Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) centralized.
The standard drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Qi Lijing, Gao Shan, Zhang Haiming, Qian Xuebo, Zhang Yun.
Electronic heating moxibustion equipment
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 article
Pieces. 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
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 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.
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