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JJF 1577-2016 English PDF

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JJF 1577-2016: Program of Pattern Evaluation of Infrared Ear Thermometers
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
JJF 1577-2016	669	Add to Cart	4 days	Program of Pattern Evaluation of Infrared Ear Thermometers	Valid

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Basic data

Standard ID: JJF 1577-2016 (JJF1577-2016)
Description (Translated English): Program of Pattern Evaluation of Infrared Ear Thermometers
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A54
Classification of International Standard: 17.200
Word Count Estimation: 29,245
Date of Issue: 2016-06-27
Date of Implementation: 2016-09-27
Quoted Standard: JJF 1015-2014; JJF 1107-2003; GB/T 14710-2009; GB/T 21417.1-2008
Regulation (derived from): Notice of the General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China 2016 No.16
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine
Summary: This standard applies to the classification of 04061000 infrared ear thermometer (hereinafter referred to as ear thermometer) product type evaluation.

JJF 1577-2016: Program of Pattern Evaluation of Infrared Ear Thermometers

---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.
Program of Pattern Evaluation of Infrared Ear Thermometers National Metrological Technical Code of the People's Republic of China Infrared ear thermometer type evaluation outline 2016-06-27 released 2016-09-27 implementation State Administration of Quality Supervision, Inspection and Quarantine issued Infrared ear thermometer type evaluation outline Responsible unit. National Thermometer Technical Committee Drafting unit. China Institute of Metrology This specification entrusts the National Thermometer Technical Committee to explain The drafters of this specification. Bai Chengyu (China Institute of Metrology) Xing Bo (China Institute of Metrology) The original compliance East (China Institute of Metrology)

Introduction (Ⅲ) 1 Scope (1) 2 References (1) 3 Terms and definitions (1) 3.1 Calibration mode (1) 3.2 Laboratory errors (1) 4 Overview (1) 5 legal management requirements (2) 5.1 Unit of measurement (2) 5.2 External structure (2) 5.3 logo (2) 6 Measurement requirements (2) 6.1 indicating unit (2) 6.2 Temperature display range (2) 6.3 Laboratory errors (2) 7 General technical requirements (2) 7.1 Appearance and structure (2) 7.2 Patterns (3) 7.3 Detector cover (3) 7.4 Self-test function (3) 7.5 User's Manual (3) 7.6 Cleaning, disinfection or sterilization (3) 7.7 Tips for alarm function (3) 7.8 Automatic shutdown function (3) 7.9 Environmental test requirements (3) 8 type evaluation item table (4) 9 Technical data and test samples submitted by the applicant (4) 9.1 Technical Information Requirements (4) 9.2 Test prototype requirements (4) 10 Test methods and conditions for test items and data processing and eligibility criteria (5) 10.1 Indicator Unit Test (5) 10.2 Temperature display range test (5) 10.3 Requirements for laboratory errors within the range (6) 10.4 provides laboratory errors outside the range (7) 10.5 Laboratory errors under changing environmental conditions (8) 10.6 Cleaning, disinfection or sterilization test (8) 10.7 Alarm function 1 --- Power supply voltage (9) 10.8 Alarm function 2 --- Display range (9) 10.9 Alarm function 3 --- Ambient temperature (9) 10.10 Automatic shutdown test (10) 10.11 Storage test (10) 10.12 Drop test (11) 10.13 Vibration test (12) 10.14 Collision test (13) 10.15 Transport test (13) 10.16 Judgment of type evaluation result (14) 11 Measuring instruments and equipment for test items (14) 12 type evaluation record format (15)

Introduction

The structure and content of this outline is based on JJF 1015-2014 "General Specification for Metrological Appraisal" and JJF 1016-2014 "Measurement instrument type evaluation outline preparation guidelines" related requirements. Test requirements and test methods According to GB/T 21417.1-2008 "Medical Infrared Thermometer Part 1. Ears" and JJF 1107-2003 "Calibration of Infrared Thermometers for Measuring Human Temperature". The outline of the pilot project contains GB/T 21417.1-2008 in addition to "4.4.4 maximum allowable clinical repeatability" "4.7 Biocompatibility", "4.8 Safety requirements" and "4.15 Environmental test requirements" in the "power supply voltage adaptation Force "other than all the items. This section of the GB/T 21417.1-2008 in the "5.15 environmental test requirements" in some of the pilot test Method has been adjusted. Added "alarm function - display range" and "alarm function - ambient temperature" test side law. "Vibration test" and "collision test" in the final test link to increase the "specified temperature display range of the most Large permissible error "test." Transport test "in the final test session only" appearance and structure "and" specified Temperature display within the maximum allowable error "test. The outline for the first release. Infrared ear thermometer type evaluation outline

1 Scope

This outline applies to the classification of 04061000 infrared ear thermometer (hereinafter referred to as ear thermometer) product type Evaluation.

2 reference file

This outline refers to the following documents. JJF 1015-2014 General rules for the evaluation of measuring instruments Standard Practice for Calibration of Infrared Thermometers for Measuring Human Body Temperature JJF 1107-2003 Environmental requirements and test methods for medical appliances GB/T 14710-2009 Medical infrared thermometers - Part 1. ear - cavity type GB/T 21417.1-2008 For dated references, only the dated edition applies to this syllabus; references that are not dated , The latest version (including all amendments) applies to this outline.

3 terms and definitions

3.1 calibration mode calibrationmode The ear thermometer shows the pattern of the temperature measured from the black body of the ear thermometer. Note. 1. In the calibration mode, the ear thermometer displays the measurement of the blackbody temperature of the ear thermometer. The calibration mode is that the ear thermometer must have Working mode for the measurement of laboratory error of ear thermometer. 2. You can set the ear thermometer directly to the calibration mode or by means of mathematical operations by key operation. mode. 3.2 laboratory error errorwithinambientoperatingrange Under the specified ambient temperature and humidity conditions, the ear thermometer is shown in the calibration mode with the temperature of the ear thermometer difference. Note. 1. The provisions of the temperature and humidity conditions, including the rated working conditions and laboratory reference conditions of two environmental conditions. 2. Rated working environment conditions. temperature 16.0 ℃ ~ 35.0 ℃, humidity ≤ 85% RH. 3. Laboratory reference conditions. temperature of 23 ℃ ± 2 ℃, humidity of 50% RH ± 20% RH.

4 Overview

Infrared ear thermometer, also known as ear-type infrared thermometer, refers to the use of ear canal and tympanic membrane and the detector between the infrared radiation Exchange instrument for measuring body temperature. The ear thermometer is usually made up of optical systems, detectors and electrical systems. The thermometer shows the value Can be the ear cavity temperature or by the ear cavity temperature projections of other parts of the human body temperature, such as oral temperature, armpit temperature and rectum Temperature and so on.

5 legal management requirements

5.1 Unit of measurement The unit of temperature is in degrees Celsius and the symbol is ° C. 5.2 External structure For those who do not allow the user to adjust the ear thermometer, should be closed with the design or leave a sealed seal position. 5.3 logo Test prototype should identify the factory name or trademark, model specifications, factory number. The test prototype shall be set aside to mark the marking and number of the manufacturing instrumentation license and the type of measuring instrument Approval mark and number.

6 measurement requirements

6.1 Indicator unit 6.1.1 resolution The display resolution of the ear thermometer indicating unit should be 0.1 ° C or less. 6.1.2 Display The digit height on the thermometer display is at least 4 mm, or by visual enlargement. 6.2 Temperature display range Temperature display range should cover 35.0 ℃ ~ 42.0 ℃. 6.3 Laboratory errors 6.3.1 Specifies the laboratory error within the display range Rated working environment conditions, 35.0 ℃ ~ 42.0 ℃ display range, ear thermometer laboratory error should not exceed ± 0.2 ℃. 6.3.2 Specifies the laboratory error outside the range Rated working environment conditions, 35.0 ℃ ~ 42.0 ℃ display range, ear thermometer laboratory error should not exceed ± 0.3 ℃. 6.3.3 Laboratory errors under changing environmental conditions When the environment is in rated working conditions, but the ambient temperature changes rapidly, the ear thermometer laboratory error should Meet the requirements of 6.3.1, or stop providing temperature readings. General technical requirements 7.1 appearance and structure 7.1.1 The surface of the ear thermometer shall be bright and clean and shall not have obvious scratches, breakage and deformation. 7.1.2 The words and signs on the surface of the ear thermometer shall be accurate, clear and firm. 7.1.3 The control and adjustment mechanism of the ear thermometer shall be flexible and reliable, and the fasteners shall be free from loosening. 7.1.4 The function keys of the ear thermometer shall be clearly marked and indicated. 7.2 mode When the ear thermometer has a variety of measurement modes, the current measurement mode should be clearly identified. Note. The ear thermometer may have multiple measurement modes at the same time, such as calibration mode, ear temperature mode, and one or more estimation modes. calibration The mode is the operating mode that the ear thermometer must have. Estimation patterns include oral mode, axillary temperature pattern, rectal pattern, and the like. 7.3 Detector cover 7.3.1 If the manufacturer requires the use of a detector guard, it shall be placed at the front of the detector, in the temperature measurement The measured object and the detector front to play a role in health protection. 7.3.2 If the manufacturer requires the use of a detector cover for the ear thermometer, in the absence of a detector cover When used, the thermometer should stop displaying the temperature reading, or a message should appear before each measurement. Requires every measurement to make With a new detector cover, a warning statement should be made by the manufacturer in the instructions. 7.3.3 The ear thermometer using a disposable detector cover shall be replaced with a new probe for each measurement in 6.3 test Protective cover. 7.4 self-test function The ear thermometer should have an automated self-test procedure and provide operational information and clear description of the ear The display feature when the thermometer is in the normal state. 7.5 User's Manual The instruction manual should include at least the following. 7.5.1 Temperature display range, temperature unit, maximum permissible error (or accuracy), normal operating conditions and storage condition. 7.5.2 Conversion methods for different measurement modes (for ear thermometers with multiple measurement modes). 7.5.3 measured object, body parts. 7.5.4 Detector cover (if any) is a one-time or multiple use, multiple disinfection methods and Storage conditions. 7.6 Clean, disinfect or sterile If the manufacturer expresses that the ear thermometer can be cleaned, sterilized and/or sterilized, guidance on these operations should be provided Description. After the ear thermometer is cleaned, sterilized and/or sterilized in accordance with the manufacturer's method, the mark of the ear thermometer And the description shall be legible and shall comply with the requirements of 6.3.1. 7.7 prompts the alarm function When one or more of the following data exceeds the manufacturer's specified limits, the ear thermometer should have sound, light, or display prompt / Alarm signal, or stop providing temperature readings. 7.7.1 Supply voltage (for ear thermostat with internal DC power supply). 7.7.2 Display range. 7.7.3 Ambient temperature. 7.8 automatic shutdown function Internal thermoelectric power supply of the ear thermometer should have an automatic shutdown function, with a multi-functional ear thermometer with the exception. 7.9 Environmental test requirements 7.9.1 Storage test In the absence of electricity and complete packaging conditions, the ear thermometer in the environmental conditions shown in Table 1 to save a certain time and return to After the laboratory reference conditions, the requirements of 6.3.1 shall be met. Table 1 Storage test items and test conditions Pilot projects Test conditions temperature humidity Test requirements Box test time/h box recovery time/h Low temperature storage -20 ℃, --- ① 4 4 High temperature storage 55 ℃, --- ① 4 4 Wet heat storage at 40 ° C, 93% RH 48 24 Note. ① environmental humidity generally ≤ 70% RH, the prototype surface can not be exposed or frost. 7.9.2 Drop test The ear thermometer in the normal use from the vertical distance of 1m high to three different starting post free fall to a The hard surface shall comply with the requirements of 7.1 and meet the requirements of 6.3.1 or stop providing temperature readings. 7.9.3 Vibration test In accordance with GB/T 14710-2009 Table 1 "vibration test" group Ⅱ requirements after the test should be consistent with 7.1 and 6.3.1 Requirements. 7.9.4 Collision test In accordance with GB/T 14710-2009 Table 1 "collision test" group Ⅱ requirements after the test should be consistent with 7.1 and 6.3.1 Requirements. 7.9.5 Transport test In accordance with GB/T 14710-2009 in the 4 "transport test" requirements of the test, should be consistent with 7.1 and 6.3.1 Claim.

8 type evaluation item list

The type of evaluation of the ear thermometer is shown in Table 2. Table 2 List of types of evaluation items No. Category Item Terms 1 Observation items 5.1, 5.2, 5.3, 7.1, 7.2, 7.3, 7.4, 7.5 2 Experimental items 6.1, 6.2, 6.3, 7.6, 7.7, 7.8, 7.9

9 technical information submitted by the applicant and the test prototype

9.1 Technical information requirements The technical information submitted by the applicant unit shall meet the requirements of JJF 1015-2014. 9.2 Test prototype requirements The applicant unit shall provide the test prototype and shall pass the factory inspection according to the enterprise standard. 9.2.1 Number of prototypes provided For a single product, the number of prototypes is 3 units. For a series of products, select a representative of the product, the number of samples for each product for the three. Representative The product shall be processed by the government measurement administration department of the accepted application and the technical institution undertaking the test according to the technical information provided by the applicant To determine. The following factors should be considered when determining the sample type or specification. a) the same accuracy, the measurement range of different products in the selection of the prototype should include the upper and lower limits of the measurement range product. b) The accuracy of the different measurement range and structure of the same series of products in the selection of the prototype should be included in the accuracy Grade products. c) usually, different optical path, different models of major components or different technical indicators of different specifications of the product should not be divided For the same series. 9.2.2 How to use the prototype All test items shall be carried out on all prototypes and the prototype shall not be adjusted during or during the test. 10 Test methods and conditions for test items and data processing and eligibility criteria 10.1 Indication unit test ---Test purposes Verify that the test prototype meets the requirements of 6.1.1 and 6.1.2. ---Test conditions Environmental conditions. laboratory reference conditions. --- test equipment Vernier caliper. --- test procedure Manually operate the instrument, visual observation prototype display resolution. Use the vernier caliper to measure the contour height of the number displayed on the prototype display and record it. Qualified Criteria Meet the requirements of 6.1.1 and 6.1.2 for the qualified, otherwise failed. 10.2 Temperature display range test ---Test purposes Verify that the test prototype meets the requirements of 6.2. ---Test conditions Environmental conditions. laboratory reference conditions. --- test equipment Ear thermometer blackbody. --- test procedure The black body radiation temperature is set in the following two temperature zones repeated test, observe the ear thermometer display. a) show temperature lower limit test temperature zone. (ear thermometer minimum display temperature value - manufacturer specified maximum allowable error Of the absolute value of -0.5 ℃) ~ (ear thermometer minimum display temperature value of the maximum allowable error specified by the manufacturer 0.5 ° C). b) Display temperature upper limit Insulation zone. (maximum temperature of the ear thermometer - maximum permissible error specified by the manufacturer Poor absolute value of -0.5 ° C) ~ (maximum temperature of the ear thermometer shows the absolute maximum allowable error specified by the manufacturer Value of 0.5 ° C). Qualified Criteria Meet 6.2 requirements for qualified, otherwise failed. 10.3 Specifies the laboratory error within the display range ---Test purposes Verify that the test prototype meets the requirements of 6.3.1. ---Test conditions The test conditions are shown in Table 3. Table 3 specifies the environmental requirements for laboratory errors within the display range Test items Test conditions (temperature, humidity) Laboratory reference conditions 23 ℃ ± 2 ℃, 50% RH ± 20% RH ① Rated working low temperature test 16 ℃, --- ② Rated work high temperature test 35 ℃, --- ② Rated work damp heat test 35 ℃, 85% RH Note. ① ambient temperature and humidity can be within the specified range, not in the temperature and humidity laboratory to carry out the test. ② environmental humidity generally ≤ 70% RH, and the instrument surface can not be exposed or frost. --- test equipment a) ear thermometer blackbody; b) hot and humid chamber (room). --- test procedure a) The test sequence is. laboratory reference conditions → rated working low temperature test → rated working high temperature test → rated Work damp heat test. Prototype in the test environment conditions need to be stable after 30min laboratory error test, such as system Producer otherwise stipulates that the stabilization time can be extended. b) Place the ear thermometer and the prototype in a damp heat test chamber (chamber) at an average rate of 0.3 ° C/min ~ Temperature change at 1.0 ° C/min Change the temperature of the wet heat chamber (chamber) to the laboratory reference strip shown in Table 3 The provisions of the value, and then adjust the humidity to the relative humidity, after the stability of the laboratory error test. When the laboratory environment Conditions to meet the laboratory reference conditions of temperature and humidity requirements, laboratory reference conditions under the laboratory error test can be in the In the laboratory. c) Set the ear thermometer black body temperature. The reproducible temperature point is 35.2 ° C, 37.0 ° C, 41.8 ° C, or according to the sample The technical indicators of the machine to increase the temperature point. d) After the ear thermometer reaches the set temperature point and stabilize, use the prototype to measure the temperature of the ear thermometer blackbody. measuring , The prototype should be in the calibration mode, the probe should be as fast as possible with the cavity opening flush, into the cavity should not exceed 2mm. Use a one-time probe guard for the prototype, each measurement should replace the new probe cover. e) at the same time record the ear thermometer black body temperature reference value tR, i and prototype indication tEUT, i. Each temperature point, Each prototype is measured 3 times. f) Determine the laboratory error Δti of the single measurement of the prototype according to the "data processing" method of 10.3 According to 10.3 ......

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