JB 20007.3-2004 Oral liquid bottle filling linkage line tunnel type sterilization dryer
Some standard content:
JB | Linkage line
Antibiotic glass bottle powder dispensing linkage line
Linear plunger filling machine
Released on 2004-02-05
Implemented on 2004-06-01| |tt||National Development and Reform Commission released
ICS11.120.30
C92
JB
Pharmaceutical Machinery Industry Standard of the People's Republic of China JB20007.3—2004||tt ||Replacing YY0217.3—1995
Oral liquid bottle filling linkage line
Tunnel type sterilizing and drying machine
Production line for filling oral liquidTunneltype sterilizingdryer
2004 -02-05 Released
2004-06-01 Implementation
National Development and Reform Commission Released
Foreword·
1 Scope
2 Normative References Documents
3 Classification and labeling
4 Requirements
5 Test methods
6 Inspection rules
7 Marks, instructions for use, packaging and storage items|| tt||times
JB20007.32004
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JB20007.3—2004
Foreword
This standard is based on the "Good Manufacturing Practice for Pharmaceuticals" and GB /T1.1-2000, GB/T1.2-2002 standardization work guide requirements, revision of YY0217.3-1995 "Tunnel Sterilization Dryer". This standard replaces YY0217.3-1995 from the date of implementation. Compared with YY0217.3-1995, the main technical content changes of this standard are as follows: a) The main chapters and clauses of YY0217.3-1995 are deleted: 3.2, 3.3;
4.1.2, 4.3.2, 4.5 .7, 4.6
5.2.5.4.5.5;
6.2.2.2
—7.3;
An additional note.
Revised the main chapters and articles of YY0217.3-1995: b)
Chapter 1;
-Chapter 2;
-3.1||tt| |4.1, 4.2, 4.3, 4.4, 4.5;
5.15.3, 5.11, 5.12, 5.13
6.2.1.1, 6.2.2.1b.6.2.2.3;
7.1. 2, 7.2, 7.4.
c) Mainly added chapters and clauses in this standard:
See 4.2.4.4.4.5.4.7.4~4.7.8
See 5.1.5.3.1.5.3.2, 5.3 .3, 5.3.4; see 6.2.2.3;
see 7.2.
This standard is proposed by China Pharmaceutical Equipment Industry Association. This standard is under the jurisdiction of the Pharmaceutical Equipment Industry Standardization Technical Committee. This standard was drafted by: Beijing Aerospace Wanda Technology Development Center. The main drafters of this standard: Shua Jingzhou, Xin Yi, Wang Zhaoli. 24
1 Scope
Oral liquid bottle filling linkage line tunnel sterilization and explosion drying machine JB20007.3—2004
This standard specifies the classification of tunnel sterilization dryers and markings, requirements, test methods, inspection rules and signs, instructions for use, packaging, and storage.
This standard applies to tunnel sterilization dryers (hereinafter referred to as sterilizers) for oral liquid bottles and antibiotic bottles. 2 Normative reference documents
The provisions in the following documents become provisions of this standard through reference in this standard. For dated referenced documents, all subsequent amendments (excluding corrigenda) or revisions do not apply to this standard. However, parties reaching an agreement based on this standard are encouraged to study whether to use the latest versions of these documents. For undated referenced documents, the latest edition applies to this standard. GB/T191 Packaging, storage and transportation pictorial mark
GB2641 Controlled anti-bacterial glass bottles
GB5226.1-2002 Mechanical safety machinery and electrical equipment Part 1: General technical conditions CB/T6388 Transport packaging receipt and delivery Logo
GB/T9969.1 General instructions for use of industrial products GB/T13306 Labels
GB/T13384 General technical conditions for mechanical and electrical product packaging GB/T16769
Noise pressure level of metal cutting machine tools Measurement Method JG/T19 Laminar Flow Clean Workbench Inspection Standard YY0056 Controlled Oral Liquid Bottle
Edition) National Pharmacopoeia Commission 3 classification and marking
3.1 classification
The sterilization machine has an overall tunnel structure and adopts the principle of hot air laminar flow sterilization or far-infrared radiation heating sterilization principle. 3.2 Model
3.2.1 The model of the sterilizer should comply with the regulations of YY/T0216. 3.2.2 Model mark:
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JB 20007.32004
Y
3.2.3 Marking example:
SM
Main parameters: Controlled oral liquid bottle specifications (mL) product type and feature code: S-tunnel type; M - sterilization and drying L - linkage line
Product function code: indicates oral liquid machine YLSM10 type: indicates suitable for 10mL control Tunnel sterilization dryer for oral liquid bottles. 4 Requirements
4.1 Working conditions
4.1.1 Ambient temperature: 18℃~28℃.
4.1.2 Ambient air cleanliness: Class 100,000. 4.1.3 The average wind speed in the sterilizer operating area should not be less than 0.35m/s. 4.1.4 The washed bottles should be clean and free of residual water. 4.2 Material requirements
The box of the sterilizer and the conveyor belt in the box are made of stainless steel materials that are corrosion-resistant, moisture-resistant, high-temperature-resistant and wear-resistant and have stable chemical properties, and have corresponding material certificates. 4.3 Appearance requirements
4.3.1 The outer surface of the sterilizer must be flat, smooth, without unevenness, burrs, obvious scratches and other defects. 4.3.2 The nameplates, warning signs, function identification marks and grounding symbols installed on the sterilizer should be complete, effective, durable, and clear and easy to remember.
4.4 Structural requirements
4.4.1 The sterilization machine box should be divided into a preheating area, a high-temperature sterilization area and a cooling area. 4.4.2 The tunnel base of the sterilizer includes a transmission motor, reducer and stainless steel conveyor mesh belt. 4.4.3 The interface between the sterilizer and the cleaning machine adopts crawler transmission or rail insertion type. The interface between the sterilizer and the filling and rolling machine adopts a vibrating mesh belt or a pneumatic bottle pushing device. The workbench of the sterilizer should have a vertical height adjustment device. 4.4.4 The sterilizer should have a temperature display and recording device, and a conveyor belt pine and purple adjustment device. 4.4.5 The sterilizer should be equipped with a purification filter that meets the relevant requirements of the "Pharmacopoeia of the People's Republic of China" (2000 edition). 4.5 Functional requirements
4.5.1 Control function:
Control the conveyor belt speed: control the temperature in the box: control the residence time of the bottle in the high-temperature sterilization area; when the temperature in the box is high At 100℃, the fan cannot stop rotating. 4.5.2 Display function:
The temperature indication recorder displays and records the temperature inside the box in real time. 4.5.3 Interlock function:
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When the fan fails and stops, the heating should automatically stop and the conveyor belt should stop. When bottles accumulate at the outlet, the conveyor belt stops rotating. 4.5.4 Protection function:
4.5.4.1 When the temperature inside the box is lower than the set temperature, the conveyor belt will not rotate. 4.5.4.2 When the fan is not operating normally, the heating pipe will not be powered on. 4.5.4.3 When the actual temperature in the box is higher than the set temperature, the heating pipe will be automatically powered off. 4.6 Performance requirements
4.6.1 The temperature of the sterilization area in the box should not be lower than 300℃. The bottle should stay in the high temperature sterilization area for no less than 5 minutes. 4.6.2
4.6.33
The bottle temperature at the exit of the sterilizer should not exceed room temperature by 10°C. 4.6.48
The temperature of the outer wall of the box shall not exceed room temperature by 15°C (excluding the entrance). 4.6.5 The temperature of the sterilizer should be automatically controlled and recorded. 4.6.63
The cleanliness inside the sterilizer should reach level 100. The noise pressure of the sterilizer during load operation shall not exceed 80dB(A). 4.6.73
4.6.8 The sterilized bottles should comply with the relevant regulations in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 4.7 Safety requirements for electrical systems
JB20007.3—2004
4.7.1 The continuity of the protective grounding circuit of the electrical system shall comply with the provisions of 19.2 in CB5226.12002. 4.7.2 The insulation resistance of the electrical system shall comply with the provisions of 19.3 in CB5226.1-2002. 4.7.3
The withstand voltage of the electrical system shall comply with the provisions of 19.4 in GB5226.1-2002. 4.7.4
The protective grounding circuit of the electrical system shall comply with the provisions of 8.2 in GB5226.12002. 4.7.5
The buttons of the electrical system shall comply with the provisions of 10.2 in CB5226.1-2002. The indicators and displays of the electrical system should comply with the provisions of 10.3 in GB5226.1-2002. 4.7.6
4.7.7
The wiring of the electrical system shall comply with the provisions of Chapter 14 of GB5226.1-2002. The markings, warning signs and project codes of electrical systems should comply with the provisions of Chapter 17 of GB5226.1-2002. 4.7.8
5 Test method
5.1 Working condition test
5.1.1 The average wind speed in the sterilizer operating area is measured with a wind speed tester. 5.1.2 Visually inspect the quality of the cleaned bottles. 5.2 Material, appearance and structure test
Visually inspect the material certification data, machine appearance and structure of the materials used in the sterilizer. 5.3 Functional test
5.3.1 Control function test:
Before the sterilizer leaves the factory, a commissioning test is carried out simulating normal production procedures. 5.3.2 Display function test:
Visually inspect the function of the display instrument during the operation test. 5.3.3 Chain function test:
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JB20007.3—2004
Stop any laminar flow fan in the sterilizer, and the entire sterilizer should stop Work. When too many bottles accumulate at the bottle outlet, the conveyor belt should stop running. 5.3.4 Protection function test:
simulates the protection function when the temperature inside the box is lower than the set temperature, when the fan is not operating normally, and when the actual temperature inside the box is higher than the set temperature.
5.4 Performance test
5.4.1 High-temperature sterilization area temperature test:
Under normal working conditions of the sterilizer, use a temperature measuring instrument to detect the temperature of the high-temperature sterilization area. 5.4.2 High-temperature sterilization time test:
Under the normal working condition of the sterilizer, use a stopwatch to measure the time the bottle stays in the high-temperature sterilization zone. 5.4.3 Bottle exit temperature rise test:
Within 1 minute after the bottle leaves the sterilizer, use a semiconductor point thermometer to measure the bottle temperature. 5.4.4 Sterilizer outer wall temperature rise test:
The sterilizer operates continuously at the highest temperature for 1 hour. Use a semiconductor point thermometer to measure the following five temperature points on the side of the sterilizer (see Figure 1). Take the arithmetic mean of its temperature rise.
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5.4.5 Cleanliness test in the box:
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Picture 1
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When the sterilizer is in normal working condition, the cleanliness inside the box shall be inspected according to the regulations in JG/T19. 5.4.6 Noise test:
When the sterilizer is under load operation, use a sound level meter to test according to the regulations of GB/T16769. 5.4.7 Sterility test:
After sterilization, samples should be taken from the sterilized bottles and the sterility test should be carried out in accordance with the relevant regulations in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.5 Electrical system quality test
5.5.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively.
5.5.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 28
6 Inspection Rules
6.1 Each sterilizer must pass the quality test and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection classification
The inspection of sterilizers is divided into factory inspection and type inspection. 6.2.1 Factory inspection
JB20007.32004
6.2.1.1 Factory inspection shall be carried out one by one according to the requirements in Table 1. Only those that pass the test shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project category
General items
Main items
Inspection items
4.2,4.3,4.4,4.5.2||tt ||4.5.1, 4.5.4, 4.6.1~4.6.5, 4.76.2.1.2 During the test process of the sterilizer, if unqualified products are found, they should be returned for repair and then submitted for test, such as If it is still unqualified, it will be deemed as unqualified product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory test according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules
If any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during type inspection, the product will be judged to have failed the type inspection. If one of the other items fails, the unqualified item should be retested. If it still fails, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each sterilizer has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The label of the sterilizer should include the following: 7.1.23
a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;| |tt||d) Main parameters:
e) Product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 29
1. The average wind speed in the sterilizer operating area is measured with a wind speed tester. 5.1.2 Visually inspect the quality of the cleaned bottles. 5.2 Material, appearance and structure test
Visually inspect the material certification data, machine appearance and structure of the materials used in the sterilizer. 5.3 Functional test
5.3.1 Control function test:
Before the sterilizer leaves the factory, a commissioning test is carried out simulating normal production procedures. 5.3.2 Display function test:
Visually inspect the function of the display instrument during the operation test. 5.3.3 Chain function test:
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JB20007.3—2004
Stop any laminar flow fan in the sterilizer, and the entire sterilizer should stop Work. When too many bottles accumulate at the bottle outlet, the conveyor belt should stop running. 5.3.4 Protection function test:
simulates the protection function when the temperature inside the box is lower than the set temperature, when the fan is not operating normally, and when the actual temperature inside the box is higher than the set temperature.
5.4 Performance test
5.4.1 High-temperature sterilization area temperature test:
Under normal working conditions of the sterilizer, use a temperature measuring instrument to detect the temperature of the high-temperature sterilization area. 5.4.2 High-temperature sterilization time test:
Under the normal working condition of the sterilizer, use a stopwatch to measure the time the bottle stays in the high-temperature sterilization zone. 5.4.3 Bottle exit temperature rise test:
Within 1 minute after the bottle leaves the sterilizer, use a semiconductor point thermometer to measure the bottle temperature. 5.4.4 Sterilizer outer wall temperature rise test:
The sterilizer operates continuously at the highest temperature for 1 hour. Use a semiconductor point thermometer to measure the following five temperature points on the side of the sterilizer (see Figure 1). Take the arithmetic mean of its temperature rise.
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5.4.5 Cleanliness test in the box:
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200
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Picture 1
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When the sterilizer is in normal working condition, the cleanliness inside the box shall be inspected according to the regulations in JG/T19. 5.4.6 Noise test:
When the sterilizer is under load operation, use a sound level meter to test according to the regulations of GB/T16769. 5.4.7 Sterility test:
After sterilization, samples should be taken from the sterilized bottles and the sterility test should be carried out in accordance with the relevant regulations in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.5 Electrical system quality test
5.5.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively.
5.5.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 28
6 Inspection Rules
6.1 Each sterilizer must pass the quality test and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection classification
The inspection of sterilizers is divided into factory inspection and type inspection. 6.2.1 Factory inspection
JB20007.32004
6.2.1.1 Factory inspection shall be carried out one by one according to the requirements in Table 1. Only those that pass the test shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project category
General items
Main items
Inspection items
4.2,4.3,4.4,4.5.2||tt ||4.5.1, 4.5.4, 4.6.1~4.6.5, 4.76.2.1.2 During the test process of the sterilizer, if unqualified products are found, they should be returned for repair and then submitted for test, such as If it is still unqualified, it will be deemed as unqualified product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory test according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules bzxZ.net
If any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during type inspection, the product will be judged to have failed the type inspection. If one of the other items fails, the unqualified item should be retested. If it still fails, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each sterilizer has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The label of the sterilizer should include the following: 7.1.23
a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;| |tt||d) Main parameters:
e) Product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 29
1. The average wind speed in the sterilizer operating area is measured with a wind speed tester. 5.1.2 Visually inspect the quality of the cleaned bottles. 5.2 Material, appearance and structure test
Visually inspect the material certification data, machine appearance and structure of the materials used in the sterilizer. 5.3 Functional test
5.3.1 Control function test:
Before the sterilizer leaves the factory, a commissioning test is carried out simulating normal production procedures. 5.3.2 Display function test:
Visually inspect the function of the display instrument during the operation test. 5.3.3 Chain function test:
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JB20007.3—2004
Stop any laminar flow fan in the sterilizer, and the entire sterilizer should stop Work. When too many bottles accumulate at the bottle outlet, the conveyor belt should stop running. 5.3.4 Protection function test:
simulates the protection function when the temperature inside the box is lower than the set temperature, when the fan is not operating normally, and when the actual temperature inside the box is higher than the set temperature.
5.4 Performance test
5.4.1 High-temperature sterilization area temperature test:
Under normal working conditions of the sterilizer, use a temperature measuring instrument to detect the temperature of the high-temperature sterilization area. 5.4.2 High-temperature sterilization time test:
Under the normal working condition of the sterilizer, use a stopwatch to measure the time the bottle stays in the high-temperature sterilization zone. 5.4.3 Bottle exit temperature rise test:
Within 1 minute after the bottle leaves the sterilizer, use a semiconductor point thermometer to measure the bottle temperature. 5.4.4 Sterilizer outer wall temperature rise test:
The sterilizer operates continuously at the highest temperature for 1 hour. Use a semiconductor point thermometer to measure the following five temperature points on the side of the sterilizer (see Figure 1). Take the arithmetic mean of its temperature rise.
200
5.4.5 Cleanliness test in the box:
Q
o
200
o
Picture 1
o
o
When the sterilizer is in normal working condition, the cleanliness inside the box shall be inspected according to the regulations in JG/T19. 5.4.6 Noise test:
When the sterilizer is under load operation, use a sound level meter to test according to the regulations of GB/T16769. 5.4.7 Sterility test:
After sterilization, samples should be taken from the sterilized bottles and the sterility test should be carried out in accordance with the relevant regulations in the "Pharmacopoeia of the People's Republic of China" (2000 edition). 5.5 Electrical system quality test
5.5.1 The continuity, insulation resistance and withstand voltage tests of the protective grounding circuit of the electrical system shall be tested in accordance with the provisions of 19.2, 19.3 and 19.4 in GB5226.1-2002 respectively.
5.5.2 The protective grounding circuit, buttons, indicators and displays, wiring, markings, warning signs and project codes of the electrical system shall be in accordance with GB5226.1-2002 8.2, 10.2, 10.3, Chapter 14 and Check the provisions of Chapter 17. 28
6 Inspection Rules
6.1 Each sterilizer must pass the quality test and be accompanied by a product certificate before it can leave the factory. 6.2 Inspection classification
The inspection of sterilizers is divided into factory inspection and type inspection. 6.2.1 Factory inspection
JB20007.32004
6.2.1.1 Factory inspection shall be carried out one by one according to the requirements in Table 1. Only those that pass the test shall be allowed to leave the factory and shall be accompanied by a product certificate. Table 1 Factory inspection items
Project category
General items
Main items
Inspection items
4.2,4.3,4.4,4.5.2||tt ||4.5.1, 4.5.4, 4.6.1~4.6.5, 4.76.2.1.2 During the test process of the sterilizer, if unqualified products are found, they should be returned for repair and then submitted for test, such as If it is still unqualified, it will be deemed as unqualified product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory test according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules
If any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during type inspection, the product will be judged to have failed the type inspection. If one of the other items fails, the unqualified item should be retested. If it still fails, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each sterilizer has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The label of the sterilizer should include the following: 7.1.23
a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;| |tt||d) Main parameters:
e) Product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 29
1, 4.5.4, 4.6.1~4.6.5, 4.76.2.1.2 During the test of the sterilizer, if unqualified products are found, they should be returned for repair and then submitted for test. If they are still unqualified, It will be judged as a defective product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory test according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules
If any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during type inspection, the product will be judged to have failed the type inspection. If one of the other items fails, the unqualified item should be retested. If it still fails, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each sterilizer has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The label of the sterilizer should include the following: 7.1.23
a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;| |tt||d) Main parameters:
e) Product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 29
1, 4.5.4, 4.6.1~4.6.5, 4.76.2.1.2 During the test of the sterilizer, if unqualified products are found, they should be returned for repair and then submitted for test. If they are still unqualified, It will be judged as a defective product.
6.2.2 Type inspection
6.2.2.1 Type inspection shall be carried out when one of the following situations occurs: a) When the product is trial-made or transferred to a factory for production: b) The structure, materials, When there are major changes in the process; c) When the product resumes production after 2 years of suspension; d) When the national quality supervision agency proposes a requirement for type inspection. 6.2.2.2 Sampling:
The prototypes for type inspection shall be selected from 10% of the products that have passed the factory test according to the method specified in GB/T10111, and one unit shall be tested. 6.2.2.3 Judgment rules
If any of the electrical safety performance of protective grounding circuit continuity, insulation resistance, and withstand voltage fails during type inspection, the product will be judged to have failed the type inspection. If one of the other items fails, the unqualified item should be retested. If it still fails, the product will be judged to have failed the type inspection.
7 Marks, Instructions for Use, Packaging and Storage 7.1 Marks
7.1.1 Each sterilizer has a product label fixed at the position specified on the drawing, and the label should comply with the regulations of GB/T13306. The label of the sterilizer should include the following: 7.1.23
a) Product name and model:
b) Manufacturer name:
c) Product number and manufacturing date;| |tt||d) Main parameters:
e) Product standard number.
7.1.3 Storage and transportation markings should comply with the regulations of GB/T191. 29
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