YY/T 0998-2015 English PDFUS$169.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0998-2015: Semiconductor heating and/or cooling therapy equipment Status: Valid
Basic dataStandard ID: YY/T 0998-2015 (YY/T0998-2015)Description (Translated English): Semiconductor heating and/or cooling therapy equipment Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C42 Classification of International Standard: 11.040.60 Word Count Estimation: 8,864 Date of Issue: 2015-03-02 Date of Implementation: 2016-01-01 Quoted Standard: GB 9706.1-2007; GB/T 14710-2009; GB/T 16886.1-2011; YY 0505-2012 Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8 Issuing agency(ies): State Food and Drug Administration Summary: This Standard specifies the semiconductor heating and cooling therapy equipment terminology and definitions, requirements, test methods. 3.1 This Standard applies to the definition of semiconductor heating and cooling treatment equipment (hereinafter referred to as "equipment"). This Standard does not apply to the following devices: thermal pad type treatment, medical temperature control blanket. YY/T 0998-2015: Semiconductor heating and/or cooling 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.Semiconductor heating and/or cooling therapy equipment ICS 11.040.60 C42 People's Republic of China pharmaceutical industry standards Semiconductor ramp therapy equipment Issued on. 2015-03-02 2016-01-01 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 Provisions. 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. Zhang Haiming, Qili Jing, Zhang Peng, Zhang Yun, Duan Chuan Ying, Qian wave. Semiconductor ramp therapy equipment1 ScopeThis standard specifies the treatment of semiconductor heating and cooling equipment terms and definitions, requirements, test methods. 3.1 This standard applies to heating and cooling treatment defined semiconductor device (hereinafter referred to as "equipment"). This standard does not apply to the following devices. --- Hot splint therapy instrument; --- Medical temperature control blanket.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 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety GB/T 14710-2009 medical electrical environmental requirements and test methods GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests3 Terms and DefinitionsGB 9706.1-2007 defined and the following terms and definitions apply to this document. 3.1 Using a semiconductor Peltier device temperature control within the circulating liquid, to the affected area in vitro physical warming and/or cooling, to secondary Co-therapeutic purposes device.4 Requirements4.1 Working conditions Working conditions specified by the equipment manufacturer. If there is no provision, it shall comply with the requirements of GB 9706.1-2007 Chapter 10. 4.2 Temperature range Temperature range specified by the manufacturer, the setpoint tolerance is ± 3 ℃. Heating is not higher than 41 ℃. 4.3 temperature sensor (if any) Tolerance temperature sensor should be ± 0.5 ℃. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0998-2015_English be delivered?Answer: Upon your order, we will start to translate YY/T 0998-2015_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0998-2015_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0998-2015_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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