標(biāo)準(zhǔn)編號(hào):	JB/T 20204-2022
中文名稱:	熔點(diǎn)測(cè)定儀
英文名稱:	Melting point meter
行業(yè)分類:	JB    機(jī)械行業(yè)標(biāo)準(zhǔn)
發(fā)布機(jī)構(gòu):	中華人民共和國(guó)工業(yè)和信息化部
發(fā)布日期:	2022-04-08
實(shí)施日期:	2022-10-1
標(biāo)準(zhǔn)狀態(tài):	valid
翻譯語(yǔ)言:	英文
文件格式:	PDF
中文字符數(shù):	7000 字
翻譯價(jià)格(元):	500.0
交付時(shí)間:	付款后 1~3 個(gè)工作日

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

前言 本文件按照GB/T 1.1-2020&標(biāo)準(zhǔn)化工作導(dǎo)則第1部分:標(biāo)準(zhǔn)化文件的結(jié)構(gòu)和起草規(guī)則》的規(guī)定起草。 請(qǐng)注意本文件的某些內(nèi)容可能涉及專利。本文件的發(fā)布機(jī)構(gòu)不承擔(dān)識(shí)別專利的責(zé)任，本文件由中國(guó)制藥裝備行業(yè)協(xié)會(huì)提出。 本文件由全國(guó)制藥裝備標(biāo)準(zhǔn)化技術(shù)委員會(huì)(SAC/TC 356)歸口。 1范圍 本文件規(guī)定了熔點(diǎn)測(cè)定儀的型號(hào),要求,環(huán)境試驗(yàn)方法,檢驗(yàn)規(guī)則,標(biāo)志,使用說(shuō)明書,包裝、運(yùn)輸和貯存。 本文件適用于測(cè)定固體藥品熔點(diǎn)的測(cè)定儀(以下簡(jiǎn)稱“熔點(diǎn)儀”)。 2規(guī)范性引用文件 下列文件中的內(nèi)容通過(guò)文中的規(guī)范性引用而構(gòu)成本文件必不可少的條款。其中,注日期的引用文件,僅該日期對(duì)應(yīng)的版本適用于本文件;不注日期的引用文件,其最新版本(包括所有的修改單)適用于本文件。 GB/T 191包裝儲(chǔ)運(yùn)圖示標(biāo)志 GB/T 9969工業(yè)產(chǎn)品使用說(shuō)明書總則 GB/T 10111隨機(jī)數(shù)的產(chǎn)生及其在產(chǎn)品質(zhì)量抽樣槍驗(yàn)中的應(yīng)用程序 GB/T 13384機(jī)電產(chǎn)品包裝通用技術(shù)條件 GB/T 14710-2009醫(yī)用電器環(huán)境要求及試驗(yàn)方法 GB/T 36035-2018 制藥機(jī)械電氣安至薄用要求 JB/T 20188-2017制藥機(jī)械產(chǎn)品型號(hào)編制方法 JJG 701-2008熔點(diǎn)測(cè)定儀檢定規(guī)程 3術(shù)語(yǔ)和定義 本文件沒(méi)有需要界定的術(shù)語(yǔ)和定義。 4型號(hào) 熔點(diǎn)儀型號(hào)按JB/T20188-2017的規(guī)定編制如下: 5要求 5.1外觀 目測(cè)查驗(yàn)熔點(diǎn)儀外表面應(yīng)光潔、平整,不應(yīng)有顆粒物脫落。允許涂鍍的表面其涂鍍層應(yīng)密實(shí),不應(yīng)脫落。 5.2性能 運(yùn)行熔點(diǎn)儀,查驗(yàn)線性升溫速率,應(yīng)至少包括0.5℃/min,1.o C/min,1.5 C/min,3.0 ℃/min, 5.3成品質(zhì)量 5.3.1按JJG 701-2008 中6.3.2.1規(guī)定的方法測(cè)定,熔點(diǎn)儀示值誤差應(yīng)符合表1要求， 5.3.2按JJG701-2008中6.3.3規(guī)定的方法測(cè)定,熔點(diǎn)儀示值重復(fù)性應(yīng)符合表1要求。 5.3.3按JJG701-2008 中6.3.4規(guī)定的方法測(cè)定,熔點(diǎn)儀線性升溫速率誤差應(yīng)符合表1要求。 表1性能指標(biāo) 性能指標(biāo) 項(xiàng)目 5.4電氣安全 5.4.1電氣系統(tǒng)的保護(hù)聯(lián)結(jié)電路的連續(xù)性應(yīng)符合GB/T 36035-2018中第7章的規(guī)定。5.4.2電氣系統(tǒng)的絕緣電阻應(yīng)符合GB/T 36035-2018中6.1的規(guī)定。 5.4.3電氣系統(tǒng)的耐壓試驗(yàn)應(yīng)符合GB/T 36035-2018中6.2的規(guī)定。 5.5環(huán)境 按第6章給出的試驗(yàn)方法進(jìn)行試驗(yàn),熔點(diǎn)儀的適應(yīng)環(huán)境應(yīng)符合GB/T 14710-2009中氣候環(huán)境Ⅰ組、機(jī)械環(huán)境Ⅱ組的規(guī)定。 6環(huán)境試驗(yàn)方法 熔點(diǎn)儀應(yīng)在試驗(yàn)場(chǎng)所放置24 h后,按GB/T 14710-2009中的規(guī)定進(jìn)行測(cè)定,試驗(yàn)項(xiàng)目及時(shí)間按表2進(jìn)行。 7檢驗(yàn)規(guī)則 7.1檢驗(yàn)分類 熔點(diǎn)儀的檢驗(yàn)分出廠檢驗(yàn)和型式檢驗(yàn)。 7.2出廠檢驗(yàn) 7.2.1熔點(diǎn)儀需經(jīng)制造單位質(zhì)量檢驗(yàn)部門按表3的規(guī)定逐臺(tái)進(jìn)行檢驗(yàn),檢驗(yàn)合格并附有產(chǎn)品合格證方準(zhǔn)予出廠。 表3出廠檢驗(yàn)項(xiàng)目 檢驗(yàn)項(xiàng)目 要求對(duì)應(yīng)的章條號(hào) 試驗(yàn)方法對(duì)應(yīng)的章條號(hào) 外觀 5.1 成品質(zhì)量 5.3 電氣安全 7.2.2熔點(diǎn)儀在檢驗(yàn)過(guò)程中,如發(fā)現(xiàn)不合格項(xiàng)﹐允許退回進(jìn)行修整,修整后檢驗(yàn)如仍不合格,則判定該產(chǎn)品為不合格品。 7.3型式檢驗(yàn) 7.3.1型式檢驗(yàn)條件 當(dāng)有下列情況之一,需進(jìn)行型式檢驗(yàn); a)新產(chǎn)品定型或投產(chǎn)鑒定時(shí)﹔ b)產(chǎn)品的結(jié)構(gòu),材料、工藝有重大改進(jìn),可能影響性能時(shí)﹔ c)產(chǎn)品停產(chǎn)1年后﹐恢復(fù)生產(chǎn)時(shí)﹔ d出廠檢驗(yàn)結(jié)果與上次型式檢驗(yàn)結(jié)果有較大差異時(shí)﹔ e)國(guó)家質(zhì)量監(jiān)督機(jī)構(gòu)提出進(jìn)行型式檢驗(yàn)要求時(shí); f)質(zhì)量仲栽需要時(shí)。 7.3.2型式檢驗(yàn)項(xiàng)目 7.3.3―抽樣規(guī)則 型式檢驗(yàn)的樣機(jī)應(yīng)在出廠檢驗(yàn)合格的產(chǎn)品中按GB/T 10111的方法抽取10%作為樣機(jī)(至少抽取3臺(tái)) ,檢測(cè)1臺(tái)。 7.3.4﹑判定規(guī)則 型式檢驗(yàn)中﹐全部項(xiàng)目檢驗(yàn)合格﹐判定該產(chǎn)品為合格品。若電氣系統(tǒng)保護(hù)聯(lián)結(jié)電路的連續(xù)性﹑絕緣電阻,耐壓有一項(xiàng)不合格,即判定該產(chǎn)品型式檢驗(yàn)不合格。若其他項(xiàng)有不合格時(shí),允許在已抽取的樣機(jī)中加倍復(fù)測(cè)不合格項(xiàng),仍不合格則判為該產(chǎn)品型式檢驗(yàn)不合格。 8標(biāo)志、使用說(shuō)明書、包裝、運(yùn)輸和貯存 8.1標(biāo)志 8.1.1出廠產(chǎn)品在其明顯部位應(yīng)有下列標(biāo)志: a)產(chǎn)品型號(hào)、名稱﹔ b)主要技術(shù)參數(shù); c)出廠編號(hào)、出廠日期; d制造單位名稱,商標(biāo)﹔ e)執(zhí)行標(biāo)準(zhǔn)編號(hào)。 8.1.2包裝儲(chǔ)運(yùn)圖示標(biāo)志符合GB/T 191的規(guī)定,有“向上"”“怕雨"”“禁止翻滾”等標(biāo)識(shí)， 8.2使用說(shuō)明書 產(chǎn)品使用說(shuō)明書按GB/T 9969的規(guī)定。 8.3包裝 產(chǎn)品的包裝符合GB/T 13384 的規(guī)定。包裝箱內(nèi)附有下列文件:a〉產(chǎn)品使用說(shuō)明書; b)產(chǎn)品合格證;c)裝箱單; d其他文件(如配套儀器文件)。 8.4運(yùn)輸 產(chǎn)品的運(yùn)輸按國(guó)家鐵路、公路和水路貨物運(yùn)輸?shù)挠嘘P(guān)規(guī)定。 8.5貯存 產(chǎn)品包裝后應(yīng)貯存在干燥,通風(fēng),無(wú)腐蝕性氣體的室內(nèi)。