|
US$669.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
JJF 1577-2016: Program of Pattern Evaluation of Infrared Ear Thermometers
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| JJF 1577-2016 | English | 669 |
Add to Cart
|
4 days [Need to translate]
|
Program of Pattern Evaluation of Infrared Ear Thermometers
| Valid |
JJF 1577-2016
|
PDF similar to JJF 1577-2016
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)
table of Contents
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 "qualified criteria" method to determine the prototype in the test environment, whether the laboratory error is qualified. Qualified sample
Machine for follow-up test.
g) The temperature of the hot and humid chamber (chamber) was changed at a temperature of 0.3 ° C/min to 1.0 ° C/min at an average rate
Change to the rated working temperature test conditions shown in Table 3, after stabilization according to c), d), e), f) method for rating
Laboratory error test under low temperature conditions.
h) Change the temperature of the hot and humid chamber (chamber) at an average rate of 0.3 ° C/min to 1.0 ° C/min
Change to the rated working temperature test shown in Table 3, after stabilization according to c), d), e), f) method for rating
Laboratory Error Test at High Temperature.
i) Change the temperature of the damp heat test chamber (chamber) at a temperature change of 0.3 ° C/min to 1.0 ° C/min at an average rate
Change the temperature specified in Table 3 to the rated temperature test conditions of the hot and humid test conditions, and then humidification to the relative humidity specified value, stable
The laboratory error test shall be carried out according to the method of c), d), e), f).
j) After the test, the prototype will remain in the hot and humid chamber (chamber), the test chamber (chamber) test
The temperature (at an average rate of 0.3 ° C/min ~ 1.0 ° C/min) and relative humidity is restored to ambient conditions,
To reach the temperature and humidity stability and then remove.
---data processing
For each prototype, at each temperature point, the laboratory error for a single measurement is.
Δti = tEUT, i-tR, i (i = 1, 2, 3) in ° C.
Qualified Criteria
If a single measurement result | Δti | ≤0.2 ℃, a single measurement result is acceptable; otherwise a single measurement result is not
qualified.
If all the individual measurements of a single prototype are qualified, the prototype specifies the laboratory error within the display range
Grid; otherwise unqualified.
10.4 provides a laboratory error outside the range
---Test purposes
Verify that the test prototype meets the requirements of 6.3.2.
---Test conditions
Environmental conditions. laboratory reference conditions.
--- test equipment
Ear thermometer blackbody.
--- test procedure
a) Before the test, the ear thermometer and the prototype were placed in the laboratory reference conditions and stable for at le...
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of JJF 1577-2016_English be delivered?Answer: Upon your order, we will start to translate JJF 1577-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of JJF 1577-2016_English with my colleagues?Answer: Yes. The purchased PDF of JJF 1577-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|