YY 0785-2010Clinical thermometers—Performance of electrical thermometers for continuous measurement (English PDF)

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 EN 1041 and related requirements;

--- delete the original data Appendix A and Appendix ZA, and add the Appendix A EN 12470 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.

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 EN 1041 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 EN 12470 (see Appendix A). In this case, the manufacturer has the responsibility to specify which Function is applicable to which parts of EN 12470. 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.