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JB/T 20204-2022   Melting point meter (English Version)
Standard No.: JB/T 20204-2022 Status:valid remind me the status change

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Language:English File Format:PDF
Word Count: 3000 words Price(USD):60.0 remind me the price change

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Implemented on:2022-10-1 Delivery: via email in 1~3 business day
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Standard No.: JB/T 20204-2022
English Name: Melting point meter
Chinese Name: 熔点测定仪
Professional Classification: JB    Professional Standard - Machinery
Issued by: MIIT
Issued on: 2022-04-08
Implemented on: 2022-10-1
Status: valid
Language: English
File Format: PDF
Word Count: 3000 words
Price(USD): 60.0
Delivery: via email in 1~3 business day
Foreword This document is drafted in accordance with GB/T 1.1-2020&Guidelines for Standardization Part 1: Structure and Drafting Rules of Standardization Documents. Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume the responsibility of identifying patents. This document is proposed by China Pharmaceutical Equipment Industry Association. This document is under the jurisdiction of the National Technical Committee for Standardization of Pharmaceutical Equipment (SAC/TC 356). 1 Scope This document specifies the model, requirements, environmental test methods, inspection rules, marks, operation instructions, packaging, transportation and storage of the melting point tester. This document is applicable to the tester for measuring the melting point of solid drugs (hereinafter referred to as "melting point tester"). 2 Normative References The contents in the following documents, through normative references, constitute indispensable provisions of this document. Where, for dated references, only the version corresponding to that date applies to this document; For undated references, the latest version (including all amendments) is applicable to this document. GB/T 191 Packaging Pictorial Marks for Storage and Transportation GB/T 9969 General Rules for Operating Instructions of Industrial Products GB/T 10111 Generation of Random Numbers and Its Application in Product Quality Sampling and Gun Inspection GB/T 13384 General Technical Conditions for Packaging of Mechanical and Electrical Products GB/T 14710-2009 Environmental Requirements and Test Methods for Medical Appliances GB/T 36035-2018 Requirements for Electrical Safety of Pharmaceutical Machinery JB/T 20188-2017 Pharmaceutical Machinery Product Model Preparation Method Verification Regulation of JJG 701-2008 Melting Point Tester 3 Terms and definitions There are no terms and definitions to be defined in this document. 4 Model The melting point instrument model is prepared as follows according to JB/T20188-2017: 5 Requirements 5.1 Appearance The external surface of the melting point meter shall be smooth and flat by visual inspection, and there shall be no particles falling off. The coating on the surface allowed to be coated shall be dense and shall not fall off. 5.2 Performance Run the melting point meter to check the linear heating rate, which should at least include 0.5 ℃/min, 1. o C/min, 1.5 C/min, 3.0 ℃/min, 5.3 Finished product quality 5.3.1 The indication error of melting point meter shall meet the requirements of Table 1 when measured according to the method specified in 6.3.2.1 of JJG 701-2008, 5.3.2 Determine according to the method specified in 6.3.3 of JJG701-2008, and the repeatability of the melting point meter shall meet the requirements of Table 1. 5.3.3 Determine according to the method specified in 6.3.4 of JJG701-2008, and the linear temperature rise rate error of the melting point meter shall meet the requirements of Table 1. Table 1 Performance Index performance index project 5.4 Electrical safety 5.4.1 The continuity of the protective bonding circuit of the electrical system shall comply with Chapter 7 of GB/T 36035-2018. 5.4.2 The insulation resistance of the electrical system shall comply with the provisions of 6.1 in GB/T 36035-2018. 5.4.3 The voltage withstand test of the electrical system shall comply with the provisions of 6.2 in GB/T 36035-2018. 5.5 Environment The test shall be carried out according to the test methods given in Chapter 6. The adaptive environment of the melting point instrument shall comply with the provisions of climatic environment group I and mechanical environment group II in GB/T 14710-2009. 6 Environmental test methods The melting point meter shall be placed in the test site for 24h, and then measured according to the provisions of GB/T 14710-2009. The test items and time shall comply with Table 2. 7 Inspection Rules 7.1 Inspection classification The inspection of melting point instrument includes delivery inspection and type inspection. 7.2 Delivery inspection 7.2.1 The melting point instrument shall be inspected one by one by the quality inspection department of the manufacturer according to the provisions in Table 3, and it is allowed to leave the factory after passing the inspection and attaching the product certificate. Table 3 Delivery Inspection Items Inspection items Corresponding chapter and article number required Chapter number corresponding to the test method appearance five point one Finished product quality five point three Electrical safety 7.2.2 During the inspection of the melting point instrument, if any nonconformity is found, it is allowed to return it for repair. If it is still unqualified after repair, the product will be judged as unqualified. 7.3 Type inspection 7.3.1 Type inspection conditions In case of any of the following circumstances, type inspection shall be conducted; a) New product finalization or production appraisal b) The structure, material and process of the product have been greatly improved, which may affect the performance c) When production resumes after one year of production suspension D. The results of factory inspection are significantly different from those of the previous type inspection e) When the national quality supervision institution requires type inspection; f) When quality is required. 7.3.2 Type inspection items 7.3.3 - Sampling rules 10% of the prototype of type inspection shall be taken from the products passing the factory inspection according to the method of GB/T 10111 as the prototype (at least 3 samples shall be taken), and 1 sample shall be tested. 7.3.4 Judgment rules In type inspection, if all items are qualified, the product is judged as qualified. If one of the continuity, insulation resistance and withstand voltage of the protective connecting circuit of the electrical system is unqualified, the product is judged as unqualified in the type inspection. If other items are unqualified, it is allowed to double the number of retested unqualified items in the sampled prototype. If still unqualified, the product is judged as unqualified in the type inspection. 8 Marks, instructions, packaging, transportation and storage 8.1 Marking 8.1.1 Ex factory products shall have the following marks on their obvious parts: a) Product model and name b) Main technical parameters; c) Factory number and date; D Name and trademark of the manufacturer e) Executive standard No. 8.1.2 The packaging, storage and transportation pictorial marks shall comply with the provisions of GB/T 191, with such marks as "upward", "rain proof", "no rolling", etc, 8.2 Operating instructions The product manual shall comply with GB/T 9969. 8.3 Packaging The product packaging shall comply with the provisions of GB/T 13384. The following documents are attached to the packing box: a) product instructions; b) Product certificate; c) Packing list; D Other documents (such as supporting instrument documents). 8.4 Transportation The products shall be transported in accordance with the relevant national regulations on railway, highway and waterway freight transportation. 8.5 Storage The packaged products shall be stored in a dry, ventilated room without corrosive gas.
Foreword 1 Scope 2 Normative References 3 Terms and definitions 4 Model 5 Requirements 6 Environmental test methods 7 Inspection Rules 8 Marks, instructions, packaging, transportation and storage
Referred in JB/T 20204-2022:
*GB/T 191-2008 Packaging - Pictorial Marking for Handling of Goods
*GB/T 9969-2008 General Principles for Preparation of Instructions for Use of Industrial Products
*GB/T 10111-2008 Generation of random numbers and procedures applied to sampling inspection for product quality
*GB/T 13384-2008 General specifications for packing of mechanical and electrical product
*GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
*GB/T 36035-2018 Pharmaceutical machinery—General requirements for electrical safety
*JB/T 20188-2017 Method of type symbolization for pharmaceutical machinery product
*JJG 701-2008 Verification Regulation of Melting-poin Measurement Instruments
Code of China
Standard
JB/T 20204-2022  Melting point meter (English Version)
Standard No.JB/T 20204-2022
Statusvalid
LanguageEnglish
File FormatPDF
Word Count3000 words
Price(USD)60.0
Implemented on2022-10-1
Deliveryvia email in 1~3 business day
Detail of JB/T 20204-2022
Standard No.
JB/T 20204-2022
English Name
Melting point meter
Chinese Name
熔点测定仪
Chinese Classification
Professional Classification
JB
ICS Classification
Issued by
MIIT
Issued on
2022-04-08
Implemented on
2022-10-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
3000 words
Price(USD)
60.0
Keywords
JB/T 20204-2022, JB 20204-2022, JBT 20204-2022, JB/T20204-2022, JB/T 20204, JB/T20204, JB20204-2022, JB 20204, JB20204, JBT20204-2022, JBT 20204, JBT20204
Introduction of JB/T 20204-2022
Foreword This document is drafted in accordance with GB/T 1.1-2020&Guidelines for Standardization Part 1: Structure and Drafting Rules of Standardization Documents. Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume the responsibility of identifying patents. This document is proposed by China Pharmaceutical Equipment Industry Association. This document is under the jurisdiction of the National Technical Committee for Standardization of Pharmaceutical Equipment (SAC/TC 356). 1 Scope This document specifies the model, requirements, environmental test methods, inspection rules, marks, operation instructions, packaging, transportation and storage of the melting point tester. This document is applicable to the tester for measuring the melting point of solid drugs (hereinafter referred to as "melting point tester"). 2 Normative References The contents in the following documents, through normative references, constitute indispensable provisions of this document. Where, for dated references, only the version corresponding to that date applies to this document; For undated references, the latest version (including all amendments) is applicable to this document. GB/T 191 Packaging Pictorial Marks for Storage and Transportation GB/T 9969 General Rules for Operating Instructions of Industrial Products GB/T 10111 Generation of Random Numbers and Its Application in Product Quality Sampling and Gun Inspection GB/T 13384 General Technical Conditions for Packaging of Mechanical and Electrical Products GB/T 14710-2009 Environmental Requirements and Test Methods for Medical Appliances GB/T 36035-2018 Requirements for Electrical Safety of Pharmaceutical Machinery JB/T 20188-2017 Pharmaceutical Machinery Product Model Preparation Method Verification Regulation of JJG 701-2008 Melting Point Tester 3 Terms and definitions There are no terms and definitions to be defined in this document. 4 Model The melting point instrument model is prepared as follows according to JB/T20188-2017: 5 Requirements 5.1 Appearance The external surface of the melting point meter shall be smooth and flat by visual inspection, and there shall be no particles falling off. The coating on the surface allowed to be coated shall be dense and shall not fall off. 5.2 Performance Run the melting point meter to check the linear heating rate, which should at least include 0.5 ℃/min, 1. o C/min, 1.5 C/min, 3.0 ℃/min, 5.3 Finished product quality 5.3.1 The indication error of melting point meter shall meet the requirements of Table 1 when measured according to the method specified in 6.3.2.1 of JJG 701-2008, 5.3.2 Determine according to the method specified in 6.3.3 of JJG701-2008, and the repeatability of the melting point meter shall meet the requirements of Table 1. 5.3.3 Determine according to the method specified in 6.3.4 of JJG701-2008, and the linear temperature rise rate error of the melting point meter shall meet the requirements of Table 1. Table 1 Performance Index performance index project 5.4 Electrical safety 5.4.1 The continuity of the protective bonding circuit of the electrical system shall comply with Chapter 7 of GB/T 36035-2018. 5.4.2 The insulation resistance of the electrical system shall comply with the provisions of 6.1 in GB/T 36035-2018. 5.4.3 The voltage withstand test of the electrical system shall comply with the provisions of 6.2 in GB/T 36035-2018. 5.5 Environment The test shall be carried out according to the test methods given in Chapter 6. The adaptive environment of the melting point instrument shall comply with the provisions of climatic environment group I and mechanical environment group II in GB/T 14710-2009. 6 Environmental test methods The melting point meter shall be placed in the test site for 24h, and then measured according to the provisions of GB/T 14710-2009. The test items and time shall comply with Table 2. 7 Inspection Rules 7.1 Inspection classification The inspection of melting point instrument includes delivery inspection and type inspection. 7.2 Delivery inspection 7.2.1 The melting point instrument shall be inspected one by one by the quality inspection department of the manufacturer according to the provisions in Table 3, and it is allowed to leave the factory after passing the inspection and attaching the product certificate. Table 3 Delivery Inspection Items Inspection items Corresponding chapter and article number required Chapter number corresponding to the test method appearance five point one Finished product quality five point three Electrical safety 7.2.2 During the inspection of the melting point instrument, if any nonconformity is found, it is allowed to return it for repair. If it is still unqualified after repair, the product will be judged as unqualified. 7.3 Type inspection 7.3.1 Type inspection conditions In case of any of the following circumstances, type inspection shall be conducted; a) New product finalization or production appraisal b) The structure, material and process of the product have been greatly improved, which may affect the performance c) When production resumes after one year of production suspension D. The results of factory inspection are significantly different from those of the previous type inspection e) When the national quality supervision institution requires type inspection; f) When quality is required. 7.3.2 Type inspection items 7.3.3 - Sampling rules 10% of the prototype of type inspection shall be taken from the products passing the factory inspection according to the method of GB/T 10111 as the prototype (at least 3 samples shall be taken), and 1 sample shall be tested. 7.3.4 Judgment rules In type inspection, if all items are qualified, the product is judged as qualified. If one of the continuity, insulation resistance and withstand voltage of the protective connecting circuit of the electrical system is unqualified, the product is judged as unqualified in the type inspection. If other items are unqualified, it is allowed to double the number of retested unqualified items in the sampled prototype. If still unqualified, the product is judged as unqualified in the type inspection. 8 Marks, instructions, packaging, transportation and storage 8.1 Marking 8.1.1 Ex factory products shall have the following marks on their obvious parts: a) Product model and name b) Main technical parameters; c) Factory number and date; D Name and trademark of the manufacturer e) Executive standard No. 8.1.2 The packaging, storage and transportation pictorial marks shall comply with the provisions of GB/T 191, with such marks as "upward", "rain proof", "no rolling", etc, 8.2 Operating instructions The product manual shall comply with GB/T 9969. 8.3 Packaging The product packaging shall comply with the provisions of GB/T 13384. The following documents are attached to the packing box: a) product instructions; b) Product certificate; c) Packing list; D Other documents (such as supporting instrument documents). 8.4 Transportation The products shall be transported in accordance with the relevant national regulations on railway, highway and waterway freight transportation. 8.5 Storage The packaged products shall be stored in a dry, ventilated room without corrosive gas.
Contents of JB/T 20204-2022
Foreword 1 Scope 2 Normative References 3 Terms and definitions 4 Model 5 Requirements 6 Environmental test methods 7 Inspection Rules 8 Marks, instructions, packaging, transportation and storage
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Keywords:
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