YY/T 0998-2015Semiconductor heating and/or cooling therapy equipment (English PDF)
半导体升降温治疗设备
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 0998-2015 is the English-translated version of 半导体升降温治疗设备.
YY/T 0998-2015 is the Chinese pharmaceutical industry standard for semiconductor heating and cooling therapy equipment, the device that warms or cools the treated part with a thermoelectric element.
It specifies the terms and definitions, the requirements and the test methods, covering the temperature reached at the applicator and its accuracy and stability, the protection against overheating and overcooling, the timer, the materials in contact with the skin and the electrical safety. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 0998-2015
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 Terms and Definitions GB 9706.1-2007 defined and the following
- 4 Requirements
Foreword
This 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.
1 Scope
This standard specifies the treatment of semiconductor heating and cooling equipment terms and definitions, requirements, test methods.
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 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 tests
3 Terms and Definitions
GB 9706.1-2007 defined and the following terms and definitions apply to this document.
3.1 Semiconductor heating and cooling therapy equipment
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.
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.
4 Requirements
4.1 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 °C. Heating is not higher than 41 °C.
4.3 Temperature sensor (if any)
Tolerance temperature sensor should be ± 0.5 °C.
......
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 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710-2009The environmental requirement and test methods for medical electrical equipment
- 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/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
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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