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Notification of issuing Guideline for the Management of Cold Chain (Transport and Storage) of Medical Devices(2016年第154号)

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附件Guideline for the Management of Cold Chain (Transport and Storage) of Medical Devices第一条根据《医疗器械监督管理条例》等相关法律法规的要求,为保证医疗器械生产经营企业和使用单位在运

为加强医疗器械质量监督管理,保证医疗器械生产经营企业和使用单位在运输与贮存过程中使产品符合其说明书和标签标示的特定温度要求,根据《医疗器械监督管理条例》(国务院令第650号)、《医疗器械经营监督管理办法》(国家食品药品监督管理总局令第8号)和《医疗器械使用质量监督管理办法》(国家食品药品监督管理总局令第18号),国家食品药品监督管理总局组织制定了《医疗器械冷链(运输、贮存)管理指南》,现予以发布。
   The <Guideline for the Management of Cold Chain (Transport and Storage) of Medical Devices> is generated for issuing in order to enhance the administration of Medical Device, ensure that medical devices always meet the temperature requirement as indicated in the instructions for use and labels of medical devices in the process of transportation and storage by the medical device manufacturer, distributor and the user, which is following the requirement of <Regulations on Supervisory Management of Medical Devices>, and .

特此公告。

附件:医疗器械冷链(运输、贮存)管理指南

Appendix: Guideline for the Management of Cold Chain (Transport and Storage) of Medical Devices

食品药品监管总局(CFDA)
2016年9月19日

 

 

附件

医疗器械冷链(运输、贮存)管理指南

Guideline for the Management of Cold Chain (Transport and Storage) of Medical Devices

 

第一条根据《医疗器械监督管理条例》等相关法律法规的要求,为保证医疗器械生产经营企业和使用单位在运输与贮存过程中使产品符合其说明书和标签标示的特定温度要求,特制定本指南。

Article1 The Guideline is hereby developed in accordance with the requirements in relevant laws and regulations including Regulations, such as Regulations on Supervisory Management of Medical Devices, in order to ensure that medical devices always meet the temperature requirement as indicated in the instructions for use and labels of medical devices in the process of transportation and storage products by the medical device manufacturer, distributor and the user.

第二条冷链管理医疗器械是指在运输与贮存过程中需要按照说明书和标签标示要求进行冷藏、冷冻管理的医疗器械。本指南适用于医疗器械生产经营企业和使用单位对医疗器械运输与贮存的质量管理。

Article2 Cold chain medical devices means the Medical Devices that need to be refrigerated, frozen management in accordance with the instruction and label requirements. The guideline is applicable for quality management of medical devices in the process of transportation and storage products by the medical device manufacturer, distributor and the user.

第三条从事冷链管理医疗器械的收货、验收、贮存、检查、出库、运输等工作的人员,应接受冷藏、冷冻相关法律法规、专业知识、工作制度和标准操作规程的培训,经考核合格后,方可上岗。

Article3 The staff holding the posts including receipt, acceptance, storage, inspection, shipment and transportation of medical devices shall be subject to the training on relevant laws and regulations on refrigerated and frozen handling, professional knowledge, working system and standard operating procedure, and shall not take up the post until assessed to be qualified.

 

第四条医疗器械生产企业和批发企业应根据生产、经营的品种和规模,配备相适应的冷库(冷藏库或冷冻库)及冷藏车或冷藏箱(保温箱)等设施设备。

Article4 Medical device manufacturers and wholesalers shall be equipped with suitable facilities and equipment including refrigerated storage (refrigerated warehouse or frozen warehouse), refrigerated vehicle, refrigerated cabinet or insulated cabinet based on the category and scale of production and distribution.

 

医疗器械零售企业和使用单位应根据经营、使用的品种和规模,配备相适应的冷库或冷藏设备(冷藏柜或冷藏箱等)。

  Medical device retailers and user shall be equipped with suitable refrigerated storage or refrigerated equipment (refrigerated container/cabinet) based on the category and scale of distribution and usage.

 

第五条用于贮存医疗器械的冷库应具有自动调控温度的功能,机组的制冷能力应与冷库容积相适应。为保证制冷系统的连续供电,冷库应配备备用发电机组或双回路供电系统等。

Article5 The refrigerated storage used for storage of medical device shall have the function of automatically regulating the temperature and be equipped with standby refrigeration unit, whose refrigerating capacity shall be adapted to the volume of refrigerated storage. In order to ensure continuous power supply of refrigeration system, refrigerated storage shall be equipped with standby generator unit or double circuit power supply system.

 

冷库内应划分待验区、贮存区、退货区、包装材料预冷区(货位)等,并设有明显标示。

There shall be Quarantine Area, Storage Area, Sales Return Area and Packaging Material Pre-cooling Area (goods allocation) divided in refrigerated storage and clearly marked.

 

第六条用于医疗器械运输的冷藏车应具备自动调控温度功能,车厢应防水、密闭,车厢内留有保证气流充分循环的空间。

Article6 The refrigerated vehicle used for medical device transportation shall have the function of automatically regulating temperature. The compartment shall be waterproofing and airtight, and shall have a space to ensure a full circulation of air flow.

 

第七条冷藏箱(柜)应能自动调节箱体内温度;保温箱应配备蓄冷(热)剂及隔温装置,并符合产品说明书和标签标示的储运要求。

Article7 Refrigerated container(cabinet)shall be able to automatically regulate the temperature within the cabinet; insulated cabinet shall be equipped with coolant and insulating devices, and meet the storage and transport requirements as indicated in the label and instructions for use of the product.

 

第八条用于医疗器械贮存和运输的冷库、冷藏车应配备温度自动监测系统(以下简称温测系统)监测温度。温测系统应具备以下功能:

Article8 The refrigerated storage or refrigerated vehicle used for the medical devices’ storage and transportation shall be equipped with temperature automatic monitoring system (hereinafter referred to as "temperature monitoring system") to monitor the temperature. The system shall have following functions:

 

(一)温测系统的测量范围、精度、分辨率等技术参数能够满足管理需要,具有不间断监测、连续记录、数据存储、显示及报警功能。

(I) Such technical parameters of temperature monitoring system as measurement range, accuracy and resolution shall be able to meet managerial demand, and the system shall have the function of continuous monitoring, continuous recording, data storage, display and alarm.

 

(二)冷库、冷藏车设备运行过程至少每隔1分钟更新一次测点温度数据,贮存过程至少每隔30分钟自动记录一次实时温度数据,运输过程至少每隔5分钟自动记录一次实时温度数据。

(II) The temperature data at every measuring point shall be updated at least once 1 minute during the equipment running, real-time temperature data shall be automatically recorded at least once every 30 minutes during the storage, and real-time temperature data shall be automatically recorded once every 5 minutes during the transportation.

 

(三)当监测温度达到设定的临界值或者超出规定范围时,温测系统能够实现声光报警,同时实现短信等通讯方式向至少2名指定人员即时发出报警信息。

(III) When the temperature reaches predetermined critical value or exceeds predetermined range, sound-light alarm shall be activated, and deliver alarm information to at least 2 designated persons via the communication means including text message.

 

每个(台)独立的冷库、冷藏车应根据验证结论设定、安装至少2个温度测点终端。温度测点终端和温测设备每年应至少进行一次校准或者检定。

At least two temperature measuring point terminals shall be installed in each independent refrigerated storage or refrigerated vehicle according to the verification result. Temperature measuring terminal and temperature monitoring device shall be calibrated at least once a year.

 

冷藏箱、保温箱或其他冷藏设备应配备温度自动记录和存储的仪器设备。

Refrigerated cabinet, insulated cabinet or other refrigerated equipment shall be equipped with the instruments and devices for automatic temperature recording and archiving.

 

第九条冷库、冷藏车、冷藏箱、保温箱以及温测系统应进行使用前验证、定期验证及停用时间超过规定时限情况下的验证。未经验证的设施设备,不得应用于冷链管理医疗器械的运输和贮存过程。

Article9 Refrigerated storage, refrigerated vehicle, refrigerated cabinet, insulated cabinet as well as temperature monitoring system shall be subject to pre-use verification, periodical verification and the verification under the circumstance that down time exceeds predetermined time limit. The facilities and equipment without verification shall not be used for transport and storage of cold chain medical devices.

 

(一)建立并形成验证管理文件,文件内容包括验证方案、标准、报告、评价、偏差处理和预防措施等。

(I) Establish and form verification control documents, which shall include verification protocol, standards, reports, evaluation, deviation handling and preventive actions.

(二)根据验证对象确定合理的持续验证时间,以保证验证数据的充分、有效及连续。

(II) Appropriate time for continuous verification shall be determined according to verification object so as to ensure that the verification data is sufficient, effective and continuous.

(三)验证使用的温测设备应当经过具有资质的计量机构校准或者检定,校准或者检定证书(复印件)应当作为验证报告的必要附件,验证数据应真实、完整、有效及可追溯。

(III) The device used for temperature monitoring during the verificaiton shall be calibrated by qualified metering agencies, calibration certificate (copy) shall be the necessary attachment to verification report, and verification data shall be true, complete, valid and traceable.

(四)根据验证确定的参数及条件,正确、合理使用相关设施及设备。

(IV) Correctly and rationally use relevant facilities and equipment according to the parameters and conditions determined in validation.

 

第十条在进行冷链管理医疗器械收货时,应核实运输方式、到货及在途温度、启运时间和到货时间并做好记录;对销后退回的产品还应核实售出期间的温度记录。符合要求的,应及时移入冷库内待验区;不符合温度要求的应当拒收,并做相应记录。

Article10 During the receipt of cold chain medical devices, transport methods, arrival and in-transit temperature, shipment time and arrival time shall be checked with records taken; for the sales return, the temperature records after sold shall be checked. Those meeting the requirements shall be moved to quarantine area in refrigerated storage; and those failing to meet temperature requirements shall be rejected and make the corresponding record.

 

第十一条使用冷库贮存的冷链管理医疗器械,应当在冷库内进行验收。

验收人员应当检查产品状态,并按《医疗器械经营质量管理规范》第三十八条、第三十九条或《医疗器械使用质量监督管理办法》的要求做好记录。

Article11 For the cold chain medical devices to be stored in refrigerated storage, the acceptance inspection shall be conducted within refrigerated storage.

Acceptance inspection personnel shall inspect the status of the products, and take records in accordance with the requirements in Article 38、39 of  or .

 

第十二条冷链管理医疗器械在库期间应按照产品说明书或标签标示的要求进行贮存和检查,应重点对贮存的冷链管理医疗器械的包装、标签、外观及温度状况等进行检查并记录。

Article12 Cold chain medical devices shall be stored and examined in accordance with the requirements as indicated in the instructions for use or label of medical device while in the warehouse, focusing on examining the packaging, label, appearance and temperature of cold chain medical devices stored and taking records.

 

冷库内制冷机组出风口须避免遮挡,应根据冷库验证报告确定合理的贮存区域。

The air outlet of air cooler within refrigerator should not be warded off. The product storage area shall be defined according to the verification result.

 

第十三条冷链管理医疗器械出库时,应当由专人负责出库复核、装箱封箱、装车码放工作。

Article13 When cold chain medical devices are delivered, there shall be specially-assigned person responsible for shipment check, encasement and sealing, loading and stacking.

 

使用冷藏箱、保温箱运输冷链管理医疗器械的,应当根据验证确定的参数及条件,制定包装标准操作规程,装箱、封箱操作应符合以下要求:

For transport of cold chain medical devices with refrigerated cabinet or insulated cabinet, standard operating procedure for packaging shall be developed based on the parameters and conditions verified and determined. Encasement and sealing shall meet following requirements:

(一) 装箱前应进行冷藏箱、保温箱预冷或预热。

(I) Before encasement, refrigerated cabinet or insulated cabinet shall be pre-cooled or pre-heated to the temperature range as indicated in the instructions for use or label of medical devices.

(二)在保温箱内合理配备与温度控制及运输时限相适应的蓄冷剂。

(II) The amount of Coolant in the insulated cabinet should be adapted to temperature control and transport time.

(三)冷藏箱启动制冷功能和温测设备(保温箱启动温测设备),检查设备运行正常,并达到规定的温度后,将产品装箱。

(III) Start cooling (heating) function and temperature monitoring equipment of refrigerated cabinet (start temperature monitoring equipment for insulated cabinet), and encase the product after examining that the equipment is in normal operation and reaches predetermined temperature.

(四)根据对蓄冷剂和产品的温度控制验证结论,必要时装箱应使用隔温装置将产品与蓄冷剂等冷媒进行隔离。

(IV) According to the temperature control of cool storage agent and product encasement validation, insulating devices shall be used to separate the products from refrigerants including coolant.

(五)冷链管理医疗器械的包装、装箱、封箱工作应在符合产品说明书和标签标示温度范围内的环境下完成。

(V) The packaging, encasement and sealing of Cold chain medical devices shall be completed in refrigerated environment;

 

第十四条运输冷链管理医疗器械的,应根据运输的产品数量、距离、时间以及温度要求、外部环境温度等情况,选择合理的运输工具和温控方式,确保运输过程中温度控制符合要求。

Article14 For the transport of cold chain medical devices, proper transport methods and temperature control method shall be selected based on transport quantity, transport distance, transport time, temperature requirements and external environment temperature to ensure that temperature control during the process of transport meets the requirements.

 

第十五条使用冷藏车运输冷链管理医疗器械的,应符合以下要求:

Article15 The transport of cold chain medical devices with refrigerated vehicle shall meet following requirements:

(一)提前启动制冷功能和温测设备,将车厢内预冷至规定的温度。
(I) Temperature regulating and monitoring devices shall be turned on in advance so as to pre-cool the compartment to predetermined temperature.

(二)根据验证报告确定冷藏车厢内产品的码放方式及区域,码放高度不得超过制冷机组出风口下沿,确保气流正常循环和温度均匀分布。

  (II) The stack and pattern area of product shall be ensured by the validation report. The  height of stack shall not exceeding the lower edge of air outlet of refrigerating unit, to ensure the normal circulation of air flow and uniform distribution of temperature.

(三)冷链管理医疗器械装车完毕,及时关闭车厢门,检查厢门密闭情况。

  (III) After the loading of cold chain medical devices, timely close the door of the compartment, check the airtight of the door.

(四)检查温控设备和温测设备运行状况,运行正常方可启运。

  (IV) Examine the situation of temperature regulating and monitoring devices and the shipment shall not be started until the device is in normal operation.

(五)冷链管理医疗器械在装卸过程中,应采取措施确保温度符合产品说明书和标签标示的要求。

  (V) During the loading and unloading of cold chain medical devices, corresponding actions shall be taken to ensure the temperature meets the requirements on the packaging or labels of medical devices.

 

第十六条冷链管理医疗器械发货时,应检查并记录冷藏车、冷藏箱、保温箱的温度。到货后,应向收货单位提供运输期间的全程温度记录。

Article16 For the shipment of cold chain medical devices, the temperature of refrigerated vehicle, refrigerated cabinet and insulated cabinet shall be examined and recorded. When the devices arrive, whole-process temperature records during transportation shall be provided to customer.

 

第十七条委托其他单位运输冷链管理医疗器械的,应当对承运方的资质及能力进行审核,签订委托运输协议,至少符合以下要求:

    Article17 Where other units are entrusted to transport cold chain medical devices, the qualification and capacity of the carrier shall be reviewed, transport entrustment agreement shall be signed, and following meet following requirements:

(一)索要承运方的运输资质文件、运输设施设备和运输管理监测系统验证文件、承运人员资质证明、运输过程温度控制及监测系统验证文件等相关资料。

(I) Request transport qualification document of carrier, proof and verification document of transport facilities and equipment and monitoring system, qualification certificate of shipment personnel and relevant data of temperature control and monitoring during the transportation.

(二)对承运方的运输设施设备、人员资质、质量保障能力、安全运输能力、风险控制能力等进行委托前和定期审核,审核报告存档备查。

(II) Conduct assessment before the entrustment and periodical review on the transport facilities and equipment, personnel qualification, quality assurance capability, safe transport capacity and risk control ability of the carrier, archiving the audit report for future reference.

(三)委托运输协议内容应包括:承运方制定的运输标准操作规程、运输过程中温度控制和实时监测的要求、在途时限的要求以及运输过程中的质量安全责任。

(III) Transport entrustment agreement shall include following content: the carrier shall develop and implement standard operating procedure for transportation, requirements for temperature control and real-time monitoring during the transport, requirements for in-transit time limitation as well as quality and safety responsibilities during the transport.

(四)必要时根据承运方的资质和条件,委托方可对承运方的相关人员及运输设施设备进行审查和考核。

(IV) Conduct review and assessment on relevant personnel of the carrier based on the qualification and conditions of the carrier, if necessary.

 

第十八条委托其他单位贮存冷链管理医疗器械的,受托企业应符合《医疗器械经营质量管理规范》第三十一条的要求。

Article18 If other units are entrusted to store cold chain medical devices, the entrusted enterprise shall meet the requirements in Article 31 of .

 

第十九条生产经营企业和使用单位应当制定冷链管理医疗器械在贮存、运输过程中温度控制的应急预案,并对应急预案进行验证。对贮存、运输过程中出现的断电、异常气候、设备故障、交通事故等意外或紧急情况,能够及时采取有效的应对措施,防止因异常突发情况造成的温度失控。

Article19 Manufacturers, distributors and user shall develop emergency plan for temperature control during the storage and transport of cold chain medical devices, and can take timely and effective countermeasures to prevent out of temperature control caused by abnormal emergency for power outages, abnormal weather, equipment failure, traffic accidents and other accidents or emergency situations during the storage and transportation.

 

第二十条本指南由国家食品药品监督管理总局负责解释。

Article20 The explanation of the Guideline is the responsibility of the China Food and Drug Administration (CFDA).

 

第二十一条本指南自发布之日起执行。

Article21 The Guideline shall be put into implementation upon t

 

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