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US$369.00 · In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 21417.1-2008: Clinical infrared thermometers -- Part 1: Ear [including MODIFICATION 1] Status: Valid
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| GB/T 21417.1-2008 | English | 369 |
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Clinical infrared thermometers -- Part 1: Ear [including MODIFICATION 1]
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GB/T 21417.1-2008
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Basic data | Standard ID | GB/T 21417.1-2008 (GB/T21417.1-2008) | | Description (Translated English) | Clinical infrared thermometers -- Part 1: Ear [including MODIFICATION 1] | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C38 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 16,172 | | Date of Issue | 2008-01-22 | | Date of Implementation | 2008-09-01 | | Quoted Standard | GB/T 191-2000; GB/T 2829-2002; GB 9706.1; GB 9969.1 | | Adopted Standard | BS EN 12470-5-2003, NEQ | | Regulation (derived from) | National Standard Approval Announcement 2008 No.2 (Total No.115) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This standard specifies the ear cavity of medical terms and definitions infrared thermometer, requirements, test methods, inspection rules and signs, manual, packaging, transport and storage. This section applies to the exchange via infrared radiation detector and appropriate correction value measurement and the measured object between the ear cavity, the output temperature of certain parts of the body cavity medical infrared ear thermometer. The thermometer ear cavity by measuring the thermal radiation to display the temperature of the measured object. |
GB/T 21417.1-2008: Clinical infrared thermometers -- Part 1: Ear [including MODIFICATION 1]---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 infrared thermometers Part 1. Ear
ICS 11.040.55
C38
National Standards of People's Republic of China
Medical infrared thermometer
Part 1. ear cavity
Posted 2008-01-22
2008-09-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Preface Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 requires 2
Test Method 4 5
6 Inspection rules 8
7 signs, instructions, packaging, transportation and storage 9
Appendix A (informative) To determine the accuracy of clinical trials 10
Foreword
GB/T 21417 "medical infrared thermometer" is divided into two parts.
--- Part 1. ear cavity;
--- Part 2. skin type.
This section GB/T Part of 121,417.
Chapter 6 of this section are recommended, the rest are all mandatory technical content. And it shall GB 9706.1 "Medical electrical equipment - Part 1
Part I. General Requirements for Safety "supporting the use of.
Medical infrared thermometer is an infrared radiation through the exchange and the appropriate correction value with the measured object detector measures the ear cavity between the input
Display certain parts of the body temperature of a medical optical instruments. The thermometer ear cavity by measuring the thermal radiation to show the object to be measured
body temperature.
This section is not equivalent to the technical requirements BSEN12470-5.2003 "Medical thermometers - Part 5. infrared ear thermometer chamber
Performance (with a maximum limit of the device). "
Appendix A of this section is an informative annex.
This part is proposed by the State Food and Drug Administration.
This part of the National Technical Committee of Standardization for medical appliances (SAC/TC10) centralized.
This section drafted by. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, in Guangdong Province Drug Administration
Bureau of Medical Devices Department.
The main drafters of this section. Huang Xiulian, Yang Xiaoling, Lu subdivision, Chen Lihua, the new Huang, Chen Jia Ye.
Medical infrared thermometer
Part 1. ear cavity
1 Scope
GB/T 21417 in the provisions of this part of the terms and definitions ear cavity medical infrared thermometer, requirements, test methods, inspection rules and
Signs, instructions, packaging, transportation and storage.
This section applies to the infrared radiation through the exchange and the appropriate correction value with the measured object detector measures the ear cavity between the output display body
Certain parts of the body temperature of the ear cavity medical infrared thermometer (hereinafter referred to as the thermometer). The thermometer ear cavity by measuring the thermal radiation to be displayed
Measured temperature of the object.
2 Normative references
The following documents contain provisions which, through reference GB/T 21417 in this section constitute provisions of this section. For dated reference documents
Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section
Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this
section.
GB/T 191-2000 Packaging - Pictorial signs (eqv ISO 780.1997)
GB/T 2829-2002 periodic inspection Sampling procedures and tables (suitable for process stability test)
GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988,
IDT)
GB 9969.1 Instructions General Industrial Products
GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1.1997)
3 Terms and Definitions
The following terms and definitions apply to this part of the GB/T 21417 of.
3.1
Ear cavity for the measured object in a non-contact infrared temperature measurement mode optical instruments.
3.2
Precisely know any opening hole wall temperature and emissivity of the hole is approximately porous reference infrared radiation source 1.0.
3.3
Measured temperature. (pulmonary artery, bladder, ear cavity, oral, rectal or axillary example) in a particular part of the body.
3.4
Thermometer reading their body parts to represent the indicated temperature (measured by a standard thermometer) proximity.
3.5
Clinical deviation and its standard deviation represents the estimate obtained by testing with a standard thermometer thermometer temperature measurement test
The average difference between the temperature of the object.
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