Some standard content:
GB1588--2001
This standard is a revised version of GB15881989 "Thermometer". The main technical differences between this standard and GB15881989 are as follows: the name "thermometer" is changed to "glass thermometer".
The relevant provisions involving glass performance in the original standard reference standard *ZBY269 Glass for thermometers" and the corresponding technical requirements and test methods, and inspection rules are cancelled (because "ZBY269 Glass for thermometers" is an abolished professional standard and there is no new standard to replace it), and the technical requirements for glass in the original standard are retained.
The types and technical parameters of neonatal stick thermometers, Yuanbao-shaped stick thermometers, and internal standard thermometers (large and small specifications) are added. In order to improve product quality, the upper limit distance l2 of the triangular stick (veterinary) thermometer is changed from ≥12m m is changed to ≥8mm. In order to facilitate the inspection of technical elements in the product, this standard has corresponding inspection methods for each technical requirement. Table 2 and Table 3 in the original standard are merged to more clearly introduce the full text of the inspection items, the required chapter numbers and the corresponding test method chapter numbers, and the sample size. After the merger, it is more convenient and faster to use and implement the standard. Two items are added, one item is modified, and one item is deleted in the periodic inspection. This standard refers to the European standard PrEN12470:2000, the American Society for Testing and Materials standard ASTME6671986, and the British standard BS691 1987, BS6985—1989
This standard replaces GB1588-1989 from the date of implementation. This standard is under the jurisdiction of the State Food and Drug Administration. The drafting unit of this standard: Shanghai Medical Instrument Factory. The main drafters of this standard: Bao Zheng, Li Qian, Cui Yunqiu. This standard was first issued in 1979 and first revised in March 1989. 513
1 Scope
National Standard of the People's Republic of China
Glass thermometer
Clinical thermometer
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GB15882001
Replaces GB15881939
This standard specifies the classification and naming, requirements, test methods, inspection rules, marking, instructions for use, packaging, transportation, storage and other requirements of glass thermometers (hereinafter referred to as thermometers). This standard applies to medical thermometers with a temperature measurement retention point structure and mercury or other metal liquids as the temperature sensing liquid; this product is used to measure the body temperature of humans and animals (veterinary use).
2 Cited standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. At the time of publication of this standard, the versions shown are valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest versions of the following standards. GB191--2000) Packaging, storage and transportation graphic signs GB 9]31985Request
(G13T2828-1987 Batch inspection counting sampling procedure and sampling table (applicable to inspection of continuous batches) Periodic inspection counting sampling procedure and sampling table (applicable to inspection of production process stability) GB/I2829---- 1987
Classification and naming
The types and parameters of thermometers shall be as specified in Table 1. Table 1 Types and parameters
Triangular stick type
Neonatal stick type
Yuanbao stick type
Internal standard type
Measuring part
Anus (for use)
3.2 The types and basic dimensions of thermometers shall be as specified in Table 2 and Figures 1 to 9. Approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on December 4, 2001514
Measurement range/C
Implementation from April 1, 2002
Angular rod type (oral cavity)
Triangular rod type (anal cavity)
Major rod type (veterinary use)
Neonatal rod type
Yuanbao type
(oral cavity)
Internal standard type
Strong inspection mark
GB 1588—2001
Basic dimensions
Factory name mark
Year of manufacture
Figure 1 Angle stick thermometer (cavity)
Strong inspection mark
Factory name mark
Year of manufacture
2 Triangular stick thermometer (anus)
5.2+ 0. 1
5.15±.0.251.150.25
12±:0. 1
GB15882001
Strong inspection mark
Factory name mark
Year of manufacture
Shape play 1
Figure 3 Triangular stick thermometer (anus veterinary use)milulwd
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Strong inspection mark
Strong inspection mark
Factory name mark
Year of manufacture
Figure 4 Internal standard thermometer (large size)
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Factory name mark
Year of manufacture
Figure 5 Internal standard thermometer (medium size)
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Form 2
Strong inspection mark
GB1588--2001
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Factory name mark
Year of manufacture
Figure 6 Internal standard thermometer (small size)
Mandatory inspection mark
Factory name mark
Year of manufacture
Yuanbao type stick thermometer (long bubble)
Mandatory inspection mark
Factory name mark
Year of manufacture
Yuanbao type stick thermometer (short bubble)
Mandatory inspection mark
GB1588----2001
Factory name mark
Figure 9 Newborn stick thermometer
Year of manufacture
3.3 When the temperature-sensing liquid is mercury, it shall comply with the provisions of No. 1 mercury in Article 1.1 of GB913-1985. 4 Requirements
4.1 The basic dimensions of the thermometer shall comply with the provisions of Table 2. 4.2 Glass
4.2.1 The glass tube shall be transparent and smooth, and no defects such as scratches, spots, air lines, bubbles, etc. that may affect the reading are allowed. 4.2.2 The glass tube shall not have any cracking phenomenon.
4.2.3 The capillaries in the glass tube shall be straight and evenly hooked, and no double pore defects containing metal liquid that may affect the reading are allowed. iiKAoNniKAca-
4.2.4 The middle of the back of the glass tube that requires prism magnification shall be lined with a milky white or other color glaze band, and the image of the temperature-sensitive liquid column after magnification from the front shall be clear and distinct. Its width: triangular stick type and neonatal stick type thermometers shall not be less than 1.2mm; ingot-shaped stick type and internal standard type thermometers shall not be less than 0.8mm.
4.3 After the temperature-sensing liquid moves in the capillary pores of the thermometer, no trace of the temperature-sensing liquid is allowed to be attached to the capillary pore wall. 4.4 Internal standard thermometer scale plate
4.4.1 The scale plate must be made of metal, paper or milky white glass. 4.4.2 The scale plate should be straight, and no haziness that affects the reading is allowed. 4.5 The quality of the temperature-sensing bulb of the thermometer shall meet the following requirements 4.5.1 The glass of the temperature-sensing bulb should not have scratches, air lines, bubbles, burrs and other defects that affect the fastness. 4.5.2 The welding part between the temperature-sensing bulb and the glass tube should be firmly welded and smooth. There should be no obvious skew. 4.5.3 There should be no impurities such as glass chips in the temperature-sensing bulb. 4.5.4 There should be no obvious bubbles in the temperature-sensing bulb. 4.6 Thermometers should be scaled according to the 1990 International Practical Temperature Scale. The minimum temperature scale is 0.1°C. The scales should be evenly spaced. The distance between the centers of two adjacent scale lines should not be less than 0.55 mm. The distance between the centers of two adjacent scale lines of a neonatal stick thermometer should not be less than 0.5 mm. 4.7 The scale plate and the glass tube containing the capillary pores used in the internal standard thermometer should be firmly placed together. The distance between the top of the glass tube and the top of the scale plate is (mm~2mm.
4.8 The casing of the internal standard thermometer should not have obvious visible impurities, and haziness that affects the reading is not allowed. 4.9 The scale lines and measurement numbers of the thermometer shall meet the following requirements 4.9.1 The scale lines and measurement numbers on the internal standard scale plate shall be clear and shall not be covered by the glass tube. The length of the scale lines extending from the glass inner core tube shall be: large and medium specifications shall not be less than 1.0mm, and small specifications shall not be less than 0.8mm. 4.9.2 The width of the rod scale line is 0.25mm±0.05mm, and the length of the 1C line and the 0.5C line can be the same, but shall be longer than 0.1 (line. 4.9.3 The width of the internal standard scale line is 0.2mm±0.05mm, and the length is: 1C line is longer than 0.5C line, 0.5 (line is longer than 0.1 (line.
4.9.4 The scale line should be straight and perpendicular to the central axis of the glass tube. 518
GB 1588-2001
4.9.5 The center of the measurement number should face the main scale line, and the position difference should not exceed - scale value. Human thermometers must be marked with two digits of \37, 40\. Newborn stick thermometers must be marked with two digits of 30, 37, 40\, and veterinary thermometers must be marked with two digits of \38\. The remaining measurement numbers can be replaced by 1 digit instead of 2 digits (for example: the number 9 represents 39C). 4.9.6 The scale line, measurement numbers and markings should be firm, and no discoloration or color pollution that affects the reading is allowed. 4.10 The thermometer should be annealed, and the stress diffusion is orange-red. The tolerance of the system value of the neonatal dilute thermometer is: ±0.15C, and the tolerance of the indication of other thermometers is: 28:19C. 4.11
4.12 The temperature-sensitive liquid column of the thermometer should not be interrupted. 4.13 The temperature-sensitive liquid column of the thermometer should not flow by itself. 4.14 The temperature-sensitive liquid column of the vernier thermometer should not be difficult to shake off. 4.15 The top of the thermometer should be smooth and round (the top for veterinary use can be in the form of Figure 3). Prevent damage to the body during use. 5 Test method
Test conditions: During the test, the technical performance of all instruments and tools should comply with the provisions of their product standards, and they should be regularly inspected and within the validity period. The test instruments, equipment, measuring tools and technical requirements are as follows: a) Steel ruler and vernier medical ruler (0.02mm); b) Special standard thermometer: indication range 34.5 (～44.5C (special standard thermometer for neonatal stick thermometer The thermometer indication range is 29.5 (~40.5 (). The minimum scale value is not greater than 0.05 (, and the expanded uncertainty Um=0.02 (: Note: The special standard thermometer must measure the zero point temperature regularly. () Polarization stress meter;
d) Tachometer: Secondary accuracy:;
e) i Reading magnifier (magnification is more than 4 times); 1) Careful temperature bath: with automatic temperature control device, the temperature difference between any two points in the working area is not greater than 0.01 (, and the temperature fluctuation during constant overflow does not exceed -+0.015 (/15min;
g) Centrifuge: The centrifugal acceleration range is 70m/s~500m/s. 5.1 Use a steel ruler or vernier caliper to check the basic The size shall comply with the provisions of 4.1. 5.2 Glass inspection
5.2.1 Observe the appearance and pores of the glass tube with force. The results shall comply with the requirements of 4.2.1, 4.2.2 and 4.2.3. 5.2.2 Observe the temperature-sensitive liquid column with a reading magnifying glass and a prism magnification. The results shall comply with the requirements of 4.2.4. 5.3 Inspection of temperature-sensitive liquid
Observe its structure with force. The results shall comply with the requirements of 4.3. 5.4 Inspection of the scale plate of internal standard thermometer
Observe visually. The results shall comply with the requirements of 4.4. 5.5 Quality inspection of temperature-sensitive bulb of thermometer
5.5.1 Observe visually. The results shall comply with the requirements of 4.5.1, 4.5.2 and 4.5.3. 5.5.2 Inspection of bubbles in temperature-sensitive bulb
No inspection is required for internal standard thermometers; periodic inspection is carried out for stick thermometers. The test method is as follows: shake the temperature-sensitive liquid column of the stick thermometer to 35 ((the temperature-sensitive liquid column of the newborn stick thermometer is shaken to below the 30 () scale line, put it in a 35 (constant overflow tank (the newborn stick thermometer is a 30C constant temperature tank) to make the temperature-sensitive liquid column rise, then put it in 0 (ice water 4 cooling temperature-sensitive bubble for 3 minutes, immediately put the thermometer into a centrifuge and throw it upside down at a centrifugal acceleration of about 120m/s to make the temperature-sensitive liquid column break from the thermometer. Place the thermometer in ((ice water cooling temperature-sensitive liquid column) Soak for about 2-3 minutes in a constant temperature bath at about 44°C. Connect the rising temperature-sensitive liquid column with the opened temperature-sensitive liquid column. Put the thermometer into a centrifuge after the connection. Use about 75ms acceleration to spin. Then check the temperature-sensitive liquid column. It is not allowed to have a temperature-sensitive liquid column that is more than 2mm out of joint. If the thermometer does not meet the requirements, it is required to be re-tested twice. If both re-tests are qualified, it is also qualified. 519
5.6 Graduation value inspection of thermometer
GB 1588—2001
Observe with a reading magnifier and visually, and the results shall comply with the requirements of 4.6. 5.7 The position between the scale plate of the internal standard thermometer and the glass tube containing the capillary holes shall be inspected by visual observation and measurement with a steel ruler, and the results shall comply with the requirements of 4.7. 5.8 Inspection of the sleeve of the internal standard thermometer
Observe with the eyes, and the results shall comply with the requirements of 4.8. 5.9 Inspection of the scale line and measurement numbers of the thermometer by reading magnifier and visual observation, and the results shall comply with the requirements of 4.9. 5.10 Stress test
Observe in the polarizing stress meter, and the results shall comply with the requirements of 4.10. 5.11 Indication test
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During the test, the ambient temperature should be between 15(~30(, so that the temperature-sensitive liquid column of the thermometer is lower than the test temperature point. The test points are: 37 and 41C for human thermometers, 35C and 39C for neonatal stick thermometers, and 38C and 42( for veterinary thermometers (other temperature points can also be used if necessary). Insert the thermometer vertically in a thermostatic bath in good working condition, with an immersion depth of not less than 60mm, and test it by comparing it with a standard thermometer.
After the temperature of the thermometer in the thermostatic bath stabilizes for 3 minutes, take it out and read it after laying it flat for 1 minute. The result should comply with the provisions of 4.11. If the thermometer does not comply with the provisions, it can be re-tested twice, and it can also be used as a thermometer if it passes the re-test twice. Qualified treatment, the results shall meet the requirements of 4.11.
5.12 Temperature-sensitive liquid column interruption test
The temperature-sensitive liquid column of the thermometer shall be observed visually during the rise and fall process, and the results shall meet the requirements of 4.12. 5.13 Temperature-sensitive liquid column self-flow test
Put the thermometer into a constant temperature bath, heat it to 42.5°C (40.5°C for neonatal stick thermometers and 43.5°C for veterinary use). After stabilization for about 3 minutes, let the bath temperature drop by 1°C within about 2 minutes, and then take out the thermometer for inspection. At this time, the temperature-sensitive liquid column shall not be lower than the scale line of 42°C (the temperature-sensitive liquid column of the neonatal stick thermometer shall not be lower than 40°C, and the temperature-sensitive liquid column of the veterinary thermometer shall not be lower than 43°C). The results shall meet the requirements of 4.13.
5.14 Test of the difficulty of shaking the temperature-sensitive liquid column
When the ambient temperature is not more than 30 (during the test, the position of the temperature-sensitive liquid column of the thermometer should not be lower than 42 (, and it should be placed in the centrifuge and shaken forward. Centrifuge acceleration: 430m/s for rod-type thermometers and 450m/s for internal standard thermometers. Take out the thermometer to observe the temperature-sensitive liquid phase: it should be lower than the 35.5 ((neon rod-type thermometer should be lower than 30.5C) scale line, and the result should meet the requirements of 4.14. For centrifuges of different radii, the number of revolutions required within 1 minute can be calculated according to the following formula: When the rotating arm of the centrifuge is horizontal
n=95.5NR -50
b) When the arm of the centrifuge is at an angle to the horizontal plane: ne
Where: n is the number of revolutions per minute of the centrifuge.r/min; u
is the centrifugal acceleration.m/s\;
/u×10
coseNR
R…~ is the radius of the centrifuge. The distance from the center of the centrifuge shaft to the bottom of the inner cavity of the centrifuge casing. It is required to be accurate to +2mm.mm. 5.15 Inspection of the top of the thermometer
After the thermometer is processed, it is inspected by force observation and touch, and the results should meet the requirements of 4.15. 520
6 Inspection rules
GB 1588--2001
Thermometers must be inspected by the national metrology inspection department or the national authorized metrology quality inspection department. Only after passing the inspection and accompanied by a product quality certificate can they be submitted for acceptance.
6.1 Inspection classification
Thermometer inspection is divided into batch inspection (factory inspection) and periodic inspection (type inspection). 6.2 Batch inspection
6.2.1 Batch inspection shall be carried out in accordance with the provisions of GB/T2828. 6.2.2 Batch rules
Thermometers shall be accepted in batches. Each batch of products shall be thermometers manufactured under basically the same materials, processes, equipment, etc. 6.2.3 The type of sampling plan adopts one-time sampling. The strictness of the sampling plan starts from the normal inspection sampling plan, and the inspection level is II. Its unqualified classification, inspection items and qualified quality level (AQL) are specified in Table 3. Table 3 Batch inspection and periodic inspection
Required
Unqualified classification
Chang Serial number
Inspection items
Bubbles in the temperature-sensing bulb
Burst of glass tube
Appearance of glass tube
Pores in glass tube
Glaze band of glass tube
Thermal liquid
Scale plate
Appearance of temperature-sensing bulb
Welding of temperature-sensing bulb
Impurities in temperature-sensing bulb
Graduation value
Scale plate and glass tube position
Scale line and measurement number
6.3 Periodic inspection
6.3.1 Periodic inspection should be carried out in the following cases: Article number
a) Before the new product is put into production (including the conversion of old products); Test method
Article number
Batch inspection
Periodic inspection
Sampling plan
b) When the product is put into production again after an interval of more than two years;
() When there are major changes in design, technology, and materials; GB 1588—2001
d) When the factory inspection results are significantly different from the last type test; () When the national quality supervision agency proposes a requirement for type inspection. - KAoNi KAca-
6.3.2 Before the periodic inspection, batch inspection should be carried out first, and samples should be taken from the qualified batches for periodic inspection. The periodic inspection should be carried out in accordance with the provisions of GB/T2829.
6.3.3 The periodic inspection adopts a one-time sampling plan, and the discrimination level is Ⅲ. The unqualified classification, number of judgment groups and unqualified quality level (RQIL) are specified in Table 3.
6.3.4 The qualified periodic inspection must be all inspection items in this cycle, and the periodic inspection must be qualified. Otherwise, the periodic inspection is considered unqualified. 7 Marking, instruction manual
7.1 Marking
Each thermometer should have the following markings in the parts shown in Figures 1 to 9: a) manufacturer code or trademark;
b) production year (the last two digits or four digits); c) international temperature scale Celsius symbol \ (\; d) printed with \［cv\ strong inspection mark.
7.2 Instructions for use
The instructions for use shall contain the following information:
a) Manufacturer's name, address and registered trademark; b) Product name and product standard number;
() Product registration certificate number, production license number, compulsory inspection mark; (l) Product scope of application, usage and precautions. 8 Packaging, transportation and storage
8.1 Packaging
The thermometer shall be packed in a paper tube or plastic tube, and the tube shall be equipped with a shockproof cushion. Several thermometers of the same type shall be packed in a small package, and the packaging box shall contain a product certificate and instructions for use (in accordance with the requirements of 7.2). There shall be a mark on the box. 8.1.1 Product certificate 1 shall contain the following information:
a) Manufacturer's name, address and registered trademark; h) Product name;
() Inspector code:
d) Product registration certificate number, production license number, compulsory inspection mark;) This standard number.
8.1.2 Small package 1 should have the following contents:
) Manufacturer's name, address and registered trademark; b) Product name and model;
() Quantity (pieces);
d) This standard number:
) Product registration certificate number, production license number, compulsory inspection mark. 8.1.3 Thermometers of the same type in small packages should be packed in large packages, and the following contents should be on the packaging box: a) Manufacturer's name, address and registered trademark; 522
h) Product name and model:
() Quantity (pieces):
l) Packer code;
() This standard number:
GB 1588:2001
() Product registration certificate number, production license number, compulsory inspection mark. 8.1.4 Thermometers of the same type as those in the larger package should be packed in a cardboard box or a wooden box, and the box should have the following information: 1) Manufacturer's name, address and registered trademark; 2) Product name and model:
() Product registration certificate number, production license number, compulsory inspection mark; 3) Quantity (pieces):
4) Net weight, gross weight (kg); 5) Standard number; 6) Overall dimensions (/tmhcmhcm):
7) Date of manufacture (year, month, day); 8) Words and marks such as "fragile items", "upward", "afraid of rain", "temperature limit", "stacking layer limit" should comply with the relevant provisions of GB191-2000, especially the upper temperature limit of 42°C should be noted, and each manufacturer shall determine the "stacking layer limit" according to the quality of the packaging materials. The words and marks on the box L should be guaranteed not to be blurred due to long-term rain. 8.2 Transportation
Transportation requirements shall be in accordance with the provisions of the order contract.
The packaged thermometer should be stored in a well-ventilated room with an ambient temperature not exceeding 42°C, dry air, relative humidity not exceeding 80%, no corrosive gas, etc.
9 Quality Assurance
Under the conditions of complying with the storage and use rules, if the thermometer cannot be used normally within two years from the date of leaving the factory (according to the product production year), the manufacturer shall repair or replace it free of charge.4. Thermometers of the same type as those in large packaging should be packed in a cardboard box or wooden box, and the box should have the following information: 1) Manufacturer's name, address and registered trademark; 2) Product name and model:
() Product registration certificate number, production license number, compulsory inspection mark; 3) Quantity (pieces):
4) Net weight, gross weight (kg); 5) Standard number; 6) Overall dimensions (/tmhcmhcm):
7) Date of manufacture (year, month, day); 8) Words and marks such as "fragile items", "upward", "afraid of rain", "temperature limit", "stacking layer limit" should be in accordance with the relevant provisions of GB191-2000, especially the upper temperature limit of 42°C should be noted, and the "stacking layer limit" is determined by each manufacturer according to the quality of the packaging materials. The words and marks on the box L should be guaranteed not to be blurred due to long-term rain. 8.2 Transportation
Transportation requirements shall be in accordance with the provisions of the order contract.
The packaged thermometer should be stored in a well-ventilated room with an ambient temperature not exceeding 42°C, dry air, relative humidity not exceeding 80%, no corrosive gas, etc.
9 Quality Assurance
Under the conditions of complying with the storage and use rules, if the thermometer cannot be used normally within two years from the date of leaving the factory (according to the product production year), the manufacturer shall repair or replace it free of charge.4. Thermometers of the same type as those in large packaging should be packed in a cardboard box or wooden box, and the box should have the following information: 1) Manufacturer's name, address and registered trademark; 2) Product name and model:
() Product registration certificate number, production license number, compulsory inspection mark; 3) Quantity (pieces): bzxz.net
4) Net weight, gross weight (kg); 5) Standard number; 6) Overall dimensions (/tmhcmhcm):
7) Date of manufacture (year, month, day); 8) Words and marks such as "fragile items", "upward", "afraid of rain", "temperature limit", "stacking layer limit" should be in accordance with the relevant provisions of GB191-2000, especially the upper temperature limit of 42°C should be noted, and the "stacking layer limit" is determined by each manufacturer according to the quality of the packaging materials. The words and marks on the box L should be guaranteed not to be blurred due to long-term rain. 8.2 Transportation
Transportation requirements shall be in accordance with the provisions of the order contract.
The packaged thermometer should be stored in a well-ventilated room with an ambient temperature not exceeding 42°C, dry air, relative humidity not exceeding 80%, no corrosive gas, etc.
9 Quality Assurance
Under the conditions of complying with the storage and use rules, if the thermometer cannot be used normally within two years from the date of leaving the factory (according to the product production year), the manufacturer shall repair or replace it free of charge.
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