YY 0902-2013 English PDFUS$399.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0902-2013: Contacting for infrared physiotherapy equipment Status: Obsolete
Basic dataStandard ID: YY 0902-2013 (YY0902-2013)Description (Translated English): Contacting for infrared physiotherapy equipment Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C42 Classification of International Standard: 11.040.60 Word Count Estimation: 9,961 Quoted Standard: GB/T 191; GB 9706.1-2007; GB/T 14710; GB/T 16886.1; YY/T 0466.1 Regulation (derived from): State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the contact far infrared therapy device (hereinafter referred to as device) terms and definitions, requirements, test methods, inspection rules, signs, instructions, packaging, transport and storage. 3. 1 This standard applies to e YY 0902-2013: Contacting for infrared physiotherapy 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.Contacting for infrared physiotherapy equipment ICS 11.040.60 C42 People's Republic of China pharmaceutical industry standards Contactless far infrared physiotherapy equipment Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. The standard safety requirements for full implementation of the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety," the content. The structure is different from the material or equipment or components specified in this standard, if they can prove that they achieve the same degree of safety, should be In recognition. 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. 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. The main drafters of this standard. Jicai Yan, Duan Chuan Ying, Yang Juan, Han desert, Zhang Yun. Contactless far infrared physiotherapy equipment1 ScopeThis standard specifies the contact far infrared therapy device (hereinafter referred to as the device) terms and definitions, requirements, test methods, inspection rules, marking Chi, instructions, packaging, transport and storage. 3.1 This standard applies to equipment regulations. This standard does not apply to equipment to far-infrared radiation the way of treatment.2 Normative referencesThe 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/T 14710 medical electrical environmental requirements and test methods GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements3 Terms and DefinitionsGB 9706.1-2007 defined and the following terms and definitions apply to this document. 3.1 Contactless far infrared physiotherapy equipment contactingfarinfraredphysiotherapyequipment Energy at a wavelength of 3μm ~ 25μm infrared spectral regions, the face of the patient-related disorder through physical therapy equipment work. 3.2 Face workface Under normal operating conditions, emitting far infrared energy and the surface in contact with the patient. 3.3 Emissivity emissivity Emissivity The amount of radiation in the object designated with the same temperature T corresponding to the temperature of blackbody radiation ratio. 3.4 Normal emissivity normalemissivity Face normal direction emissivity is called to the emission rate method.4 Requirements4.1 Working conditions It shall be specified by the manufacturer. If not specified, shall meet the requirements of Chapter 10 of GB 9706.1-2007. ...... |
