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YY 0785-2010: Clinical thermometers. Performance of electrical thermometers for continuous measurement
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Clinical thermometers. Performance of electrical thermometers for continuous measurement
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YY 0785-2010
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Basic data | Standard ID | YY 0785-2010 (YY0785-2010) | | Description (Translated English) | Clinical thermometers. Performance of electrical thermometers for continuous measurement | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 15,110 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | GB/T 2423.22-2002; GB/T 2828.2-2008; GB 9706.1-2007; GB/T 16886.1; YY 0466-2003; YY 0505-2005 | | Adopted Standard | BS EN 12470-4-2001, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the continuous measurement of the performance requirements of an electronic thermometer. This standard applies to power-driven equipment, whether it is with a net power or internal power supply. This device can be equipped with an additional indicating device, the printing apparatus, and other auxiliary devices. These accessories are not required within the scope of this standard. The amount expected to be used side skin temperature of the thermometer is not within the scope of this standard. This standard is not intended to exclude the other side based on the amount of the applicability of the principle of the device, these devices in a continuous side Tong body temperature can get equivalent performance. | YY 0785-2010: Clinical thermometers. Performance of electrical thermometers for continuous measurement
---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.
Clinical thermometers for technical performance
ICS 11.040.55
C39
People's Republic of China Pharmaceutical Industry Standard
Clinical thermometer
Continuous measurement of electronic thermometer performance requirements
(BSEN12470-4..2001, Clinicalthermometers-
Part 4. Performanceofelectricalthermometersforcontinuous
measurement, MOD)
2010-12-27 release.2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard uses the re-drafting method to modify BSEN12470-4..2001 "Clinical Thermometer Part 4. Continuous Measurement of Electronics
Thermometer performance requirements ".
The main technical differences between this standard and BSEN12470-4..2001 are as follows.
--- delete the reference to EN1041 and related requirements;
--- delete the original data Appendix A and Appendix ZA, and add the Appendix A EN12470 series of standards.
This standard also made the following editorial changes.
--- use the decimal point symbol "." Instead of the international standard in the decimal point symbol ",";
--- other standards quoted in the international standards, if the corresponding conversion to our standards, then to reference our standards;
--- delete BSEN12470-4..2001 cover and preface, according to our standard requirements to rewrite.
Please note that some of the contents of this document may relate to patents and that the issuer of this document does not assume responsibility for the identification of these patents.
This standard by the National Medical Electrical Standardization Technical Committee of medical electronic equipment standardization sub-technical committee (SAC/TC10/SC5)
Go back.
The drafting of this standard. Shenzhen Mai Rui Biological Medical Electronics Co., Ltd., Shanghai Medical Devices Testing Institute.
The main drafters of this standard. Jin Wei, Guo Yunqiu, Ye Jilun.
Introduction
Continuous measurement of electronic thermometer in the clinical application of a wide range, and China has not yet relevant standards, in order to ensure product safety and efficiency,
At the same time easy and international standards, the standard modified using BSEN12470-4..2001.
There are two reasons for the revision of this standard. First, the EN standard cited in the EN-related standards, and these EN standard domestic
Not directly into the conversion, but the conversion of the relevant ISO standards, so this standard refers to the current domestic standards. Second, because the country did not
There is a standard for the information that should be provided by the manufacturer, so this standard has removed the reference to EN1041 and related requirements.
Clinical thermometer
Continuous measurement of electronic thermometer performance requirements
1 Scope of application
This standard specifies the performance requirements for continuous measurement of electronic thermometers.
This standard applies to power-driven equipment, whether it is power supply or internal power supply.
This device can be equipped with additional pointing devices, printing devices and other auxiliary devices. The requirements of these annexes are not applicable in this standard
Inside.
It is expected that the thermometer used to measure the skin temperature is outside the scope of this standard.
This standard is not intended to exclude the applicability of devices based on other measurement principles that can be obtained when continuously measuring human body temperature
Equivalent performance.
Note. The device may contain some features that apply to the different parts of EN12470 (see Appendix A). In this case, the manufacturer has the responsibility to specify which
Function is applicable to which parts of EN12470. Such as an electronic thermometer with a maximum temperature memory device and a replaceable temperature probe.
2 normative reference documents
The terms of the following documents are hereby incorporated by reference to the terms of this International Standard. Any reference to the date of the document, which then all the repair
(Not including the contents of the errata) or the revised version shall not apply to this standard. However, it is encouraged whether the parties to reach an agreement under this standard
You can use the latest version of these files. For undated references, the latest edition applies to this standard.
GB/T 2423.22-2002 Environmental testing for electric and electronic products - Part 2. Test methods - Test N. Temperature change
(IEC 60068-2-14. 1984, IDT)
GB/T 2828.2-2008 Sampling inspection procedures - Part 2. Isolated batch inspection sampling by limit quality (LQ)
(ISO 2859-2. 1985, NEQ)
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (GB/T 16886.1-
2011, ISO /0993-1..2009)
YY 0466-2003 Medical devices Symbols for labeling, marking and providing information on medical devices (ISO 15223-2000,
IDT)
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests
(IEC 60601-1-2..2001, IDT)
3 terms and definitions
The following terms and definitions apply to this standard.
3.1
Continuous measurement of electronic thermometer
A device that continuously measures and displays human temperature, including the indicating unit and the connected temperature probe.
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