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201408 WHO第961号技术报告附录9：对时间和温度敏感的药物贮运指南技术补充文件之10：温度监控装置准确度检查
2015-07-08 00:01:12 | 分类：
Checking the accuracy of temperature control and monitoring devices 温度监控装置准确度检查 Technical supplement to WHO Technical Report Series, No. 961, 2011 WHO第961号技术报告 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products 附录9：对时间和温度敏感的药物贮运指南 技术补充文件之10 August 2014 ? World Health Organization 2014 WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: permissions@who.int). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. The named authors alone are responsible for the views expressed in this publication. Acknowledgments The author of this document is Claude Hafner of Berlinger & Co. AG., Switzerland. Abbreviations DUT | Device Under Test | SOP | Standard Operating Procedure | TTSPP | Time and Temperature-Sensitive Pharmaceutical Product |
Glossary 术语 Standard Operating Procedure (SOP): A set of instructions having the force of a directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. Standard operating policies and procedures can be effective catalysts to drive performance improvement and improve organizational results. 标准操作规程（SOP）：一套具有强制要求的指令，包括了操作的特点并成为一个定义或标准程序而不会丧失其有效性。标准操作方针和程序可以有效促进绩效改进和提高组织效果。 Temperature control device: A device which actively controls the operation of cooling plant used to store or transport TTSPPs. 温度控制装置：用于主动控制TTSPP贮运冷却机运转的装置。 Temperature monitoring device: A device which monitors the temperature of spaces used to store or transport TTSPPs. 温度监测装置：用于监测TTSPP贮运空间温度的装置。 Thermal time constant: The most common definitions of the thermal reaction time are the so-called "Tau" (τ, the 19th letter of the Greek alphabet) and "T90". "Tau" stands for the time a device needs to adapt to 63% of the end value of a temperature change whereas "T90" represents the time to adapt to 90% of the change. "T90" approximately equals to 2.5 * "Tau". These constants are commonly evaluated by experiment on the test device under well-defined conditions as described in EN12830. 热时间常数：时间常数是热敏电阻在零功率状态下，当环境温度突变时，电阻体温度由起始温度变化到最终温度的63%时所需的时间。其最常见的定义是所谓的TAU和T90，TAU对应的是63%最终温度，T90对应的是90%。T90约等于TAU的2.5倍。这些常数一般通过将测试装置放置在EN12830所述的条件下进行实验来评估获得。 Time and temperature sensitive pharmaceutical product (TTSPP): Any pharmaceutical good or product which, when not stored or transported within pre-defined environmental conditions and/or within pre-defined time limits, is degraded to the extent that it no longer performs as originally intended. 对时间和温度敏感的药品（TTSPP）：所有在贮运时如果不保持在预定的环境条件和/或预订的时间限度内则会引起一定程度降低，从而不再具有其原定性能的药品。 Triple point: The temperature and pressure at which a substance can exist in equilibrium in the liquid, solid, and gaseous states. The triple point of pure water is at 0.01 degrees Celsius and 4.58 millimetres of mercury and is used to calibrate thermometers. 三相点：三相点是指在热力学里，可使一种物质三相（气相，液相，固相）共存的一个温度和压强的数值。举例来说，水的三相点在0.0076℃（273.16K）及611.73Pa 出现；而汞的三相点在?38.8344℃及0.2MPa出现，它们被用来校正温度计。
1. Introduction 概述 This technical supplement has been written to amplify the recommendations given in Section 4.10 of WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products[1]. It describes a way to check the accuracy of temperature monitoring and temperature control devices using the “ice-water” procedure, and it outlines the limitations of this approach. This method can be used in situations where it is not possible to carry out a full three point calibration using the services of a of a nationally or internationally accredited calibration laboratory. 本技术补充文件是为了细化WHO第961号技术报告附录9：“对时间和温度敏感的药物贮运指南”第4.10部分中给出的建议。它描述了使用“冰水”程序检查温度监控装置准确度的检查方法，它勾画出了该方法的限度。本方法可以用于不能使用一个国家或国际认证校正实验室实施全部三相点校正的情况 1.1 Requirements 要求 As a general rule, temperature measurement and control devices must periodically be calibrated in order to prove their accuracy over the full operating temperature range and according to the device’s data sheet definitions. Proven accuracy is mandatory because inaccurate readings can lead to a false sense of security and place TTSPPs at risk. 作为常规，温度测量和控制装置必须定期进行校正，以证明其整个运行范围内的准确度都符合装置的数据表定义。证明准确度是强制的要求，因为不准确的读数可能会导致错误的安全感应，使得TTSPP处于风险之中。 Some devices are covered by calibration certificates from the device manufacturer. These certificates are valid for a defined period of time and the associated devices may be used throughout this period without additional calibration. An example of this is a single use temperature monitoring device which is designed to be discarded at the end of a journey, or when the battery powering the device expires. In order to ensure conformity, the manufacturer of such products must supply a calibration certificate with the device. 有些装置具有生产商出具的校正证书，这些证书在一段时间内有效，该装置可以在此有效期内使用，而不需要额外的校正。例如，一次性使用的温度监测装置的设计是在运输完成后即行抛弃，或当电池电量用尽时，装置即过效期。为了保证其符合性，这类产品的生产商必须与装置一起提供校正证书。 However, there are circumstances under which proper device calibration or re-calibration is needed. The list below is not comprehensive but illustrates some of these circumstances: 但是，有时候需要对装置进行校正或再校正。以下列出了一些需要校正或再校正的情况，但并不是完全的： l A calibration certificate is not available because it has been lost. l 校正证书找不到了 l The device is used for longer than the period covered by the calibration certificate, either at the user’s risk or with the approval of the manufacturer. l 装置的使用时间超出了校正证书给定的有效期， l The device was used or treated beyond the manufacturer's data sheet limitations (e.g. excessive temperature, shock, etc.). l 装置的使用或处理超出了生产商的数据表限度（例如，超出温度、震动等） l The battery powering the device was replaced. l 装置电池更换 l The device's measurements are suspect. l 装置的测量性能可疑 l The device manufacturer specifies that a calibration procedure should be carried out at regular intervals. l 装置生产商说明需要定期校正 l Regulatory bodies require regular proof of calibration - e.g. at 12 month intervals – and proof of calibration cannot be provided by the manufacturer’s certificate. l 法规当局要求定期校正证明----例如，每12个月----但生产商提供的证书不能证明该校正 1.2 Objectives 目的 Wherever possible, calibration should be carried out in accordance with the device manufacturer’s instructions, or by following a device-specific SOP. Ideally, a full three-point calibration should be carried out by a nationally or internationally accredited calibration laboratory with proven accuracy standards and appropriate equipment. However, there are many circumstances where accredited calibration is not possible because no suitable laboratory is available. The simple and accurate method described in this Technical Supplement can be used to prove the device’s functionality and accuracy at one single point of temperature using the so-called "ice-water procedure". 只要可能就应该根据装置生产商的指示来对装置进行校正，或者根据装置专用的SOP的校正。理想的情况是由国家或国际认可的校正实验证采用准确度经过认可的标准或适当的设备进行全三点校正。但是，很多时候可能因为没有适当的化验室因而不能进行认证的校正。本技术补充文件所述的简单准确的方法是证明装置在所用的单点温度的功能和准确度，即所谓的“冰水程序”。 1.3 Target readership 目标阅读者 This document is intended to be read by managers and technical staff who are responsible for the monitoring, installation and maintenance of temperature measurement and control equipment throughout the cold chain. Responsible managers must understand the necessity of calibration; in the absence of a suitable calibration laboratory, technical personnel must be able to carry out and/or supervise the accuracy checking procedure described below. 本文的阅读对象是整个冷链管理中负责监测、安装和维护温度测量和控制设备的管理人员和技术人员。管理责任人必须理解校正的必要性，如果没有适当的校正实验室，技术人员必须能够实施和/或监督下述检查程序的准确性。 2. Guidance 指南 The method described below is relatively simple to carry out but requires close attention to detail. The accuracy of the results are also dependent upon the use of a high quality reference thermometer with a valid calibration certificate. 下述方法相对易于执行，但要求紧密关注细节问题。结果的准确度也取决于是否使用了具有有效校正证书的高质量标准温度计。 2.1 Associated materials and equipment 辅助材料和设备 Reliable results will be achieved if the following equipment and materials are used: 如果使用了以下设备和材料，就可以获得可靠的结果： a. Wherever possible, use reference temperature measurement equipment regularly calibrated by an accredited laboratory, e.g. Fluke Hart Scientific precision equipment[2]. The illustration below shows an example of this type of instrument.
应该尽可能使用由认证过的实验室经过法规校正的标准温度测量设备，例如FLUKE HART科学精密仪器。下图是这类仪器的例子。 Figure 1 – Example of a reference thermometer 图1---标准温度计举例
Source: Fluke Hart b. Always use a temperature measurement reference instrument which is of higher accuracy than the device to be checked – for example, a thermometer with a rated accuracy of ±0.2°C should be used to check a device with a rated accuracy of ±0.3°C.
应该总是使用比所校正的装置具有更高准确度的标准温度测量仪器，例如，在检查准确度为±0.3°C的装置时应使用准确度为±0.2°C的温度计。 c. A thermally insulated container, tub open to the atmosphere, and large enough to contain enough melting ice-water in order to provide stable temperature conditions and allow full immersion of the device under test (DUT) as described in Section 3. In the cold chain operating environment, a vaccine carrier or small cold box with a hinged or separate lid would be a suitable choice. The required size depends on the dimensions of the DUT.
一个绝热敞口容器，其体积足够大，可以容纳充足的熔融冰水，可以提供稳定的温度条件，如第3所述的让待测装置（DUT）全部浸入。在冷链操作环境下，可以选择有合页或单独盖子的疫苗载体或小型冰盒。所需的尺寸取决于DUT的尺寸。 d. Disposable latex gloves.
一次性乳胶手套 e. Enough clean distilled water must be available to make ice cubes and to set up a proper and stable ice-water triple-point mixture. A transparent water-proof sealable pouch should be used to seal the DUTs before immersing it in the liquid in order to avoid water ingress and resulting damage. As much air as possible should be extracted to ensure that the DUT is in good contact with the ice-water mixture. Sealing is always recommended, even for DUT's with a high IEC 60529 IP protection class rating because the protection might have been damaged – for example by dropping or battery replacement. Where the DUT has an external sensor, the sensor may be immersed directly in the bath, provided it has an IP7 or IP8 protection class rating. Otherwise it should be sealed in a pouch as described above, with the pouch tied tightly around the lead above the level of the ice-water.
必须备有足够数量的干净蒸馏水来制作冰块，用以制作适当的稳定冰水三相点混合物。将DUT装入一个可封闭的透明防水袋中，然后浸入液体里以避免水侵入装置导致其损坏。要尽量将袋中的空气抽出，以保证DUT与冰水混合物接触良好。建议在所有情况下都使用对DUT进行封装，即使DUT是ICE60529IP保护级产品，因为保护可能已经被损坏了---例如摔坏了或换电池时弄坏了。如果仪器是IP7或IP8保护级别，如果DUT有一个外部感应器，则感应器可以直接浸入水浴中，否则应该如上述封在袋内，将袋子扎紧，线从冰水的上面伸出。 2.2 Procedure 程序 The ice-water bath provides an accurate reference temperature at 0.0°C if the melting ice - water mixture is properly set up, handled and maintained. An accurate temperature is achieved by this method because an ice-water mixture in a container which is open to the atmosphere will stabilize at its own “triple point”. At this point all three aggregate states of water coexist: liquid, solid and gaseous. For more physical details refer ASTM E563-11. 适当设置、处理和维护的冰水浴可以提供一个准确的0°C标准温度。由于容器里的冰水混合物向大气敞开，稳定在其自身的三相点，因此该方法会获得一个准确的温度。在此温度点，水的三态共存：液相、固相和气相。更多物理细节参见ASTM E563-11。 2.2.1 Prerequisites 前提条件 a. Only place clean equipment and distilled water inside the container. Use clean latex gloves to handle ice and equipment.
容器里只能放干净的设备和蒸馏水。要使用干净的乳胶手套来操作冰和设备。 b. Although the temperature of the ice-water mixture stabilizes itself, its temperature must still be monitored before and during the procedure using the calibrated reference thermometer. This is a mandatory requirement in order to prove the functionality and stability of the ice-water bath.
尽管冰水混合物的温度自身能稳定，但在校正过程中，仍必须使用校正过的标准温度计对其温度进行监测。为了证明冰水浴的功能和稳定性，这是必须的要求。 c. During extended testing periods enough ice must be added to the bath to maintain the water–ice equilibrium temperature and to prevent a possible temperature rise caused by excessive ice melting.
在延长测试期间，容器里必须加入足够的冰以保持冰水平衡温度，防止由于过量冰融化而引起温度上升。 d. Note that only DUTs which display a temperature reading can be checked by this method because the temperature indicated by the DUT must be compared to the ice-water bath temperature. Devices without a display need additional equipment to capture an immediate measurement read-out so that this can be compared with the reference temperature reading. This additional equipment is manufacturer-specific.
要注意只有显示温度读数的DUT才可以使用此方法进行检查，因为DUT显示的温度必须与冰水浴的温度进行比较。没有显示值的装置则需要另外的设备来导出其即时测量读数，这样可以与标准温度计数来比较。该另外的设备是由生产商指定的。 2.2.2 Establishing the ice-point bath (excerpt from ASTM E563-11) 建立冰点浴（摘自ASTM E563-11） a. Before using the bath, chill the required amount of distilled water close to 0.0°C.
在使用浴槽前，将所需数量的蒸馏水冷却至接近0.0°C b. Freeze a suitable amount of the same water to produce ice-cubes, making sure that there is a sufficient quantity for the complete test run.
取同样的水适量冷冻制成冰块，确保有足够数量的冰来完成一个检测流程。 c. Prepare shaved or fine crushed ice with a maximum 2mm to 3mm particle diameter; the finer the ice particles, the more accurate the ice-water temperature.
将冰弄碎到粒径为2-3mm，冰粒越细，冰水温度越准确。 d. Prepare the bath in the clean thermally insulated container. The container should be large enough not to affect the water-ice equilibrium temperature. The width, length or diameter and the overall depth must ensure that, when the thermal equilibrium state is reached, the test objects will not significantly modify the temperature of the bath over the region to which the ice point is to be applied. For normal applications, a width, length or diameter at least 100mm larger than the maximum DUT dimension size, and a depth of at least 300mm should be sufficient.
浴槽应清洁绝热。浴槽应足够大，保证其不会对冰水平衡温度形成影响。浴槽的宽度、长度或直径以及总深度必须保证在达到热平衡状态时，受测对象不会显著改变浴槽内需要保持冰点的区域温度。一般使用时，长宽或直径比最大的DUT尺寸大出至少100mm，深度至少300mm应该是足够的。 e. Alternately add shaved ice and chilled water to the vessel, using just enough water to saturate the ice but not enough to float it. As the vessel fills, compress the ice-water mixture to force out excess water. The objective is to surround each particle of ice with water, filling all voids, but to keep the ice particles as close together as possible. Continue adding ice and water and compressing until the vessel is filled to the required level. Decant or siphon off excess water.
代替加入碎冰和冷水到浴槽内，使用足够量的水来饱和冰，但不要太多使冰浮在水面上。在向浴槽中加入冰和水时，应压缩冰水混合物使多余的水流出。 f. Use the reference thermometer throughout the entire test period to confirm that a stable temperature is maintained.
在整个测试期间均使用标准温度计来确认温度维持稳定。 g. Cover the ice-point bath to protect it during the test period. Use an opaque and thermally insulating cover or stopper that is suitable for the application. This reduces heat transfer to the ambient environment through the surface of the bath. Allow the bath and vessel to equilibrate for at least 30 minutes before using.
将冰点浴盖住以在测试期间对其进行保护。使用一个适用的透明绝热的盖子或塞子。这样会减少热通过浴槽表面传播至室内环境中。在使用前要让浴槽和浴槽内容物平衡至少30分钟。 2.2.3 Placing the device in the bath 将待校装置放入冰水浴 a. Seal the DUT in a clean plastic bag. Make sure that as little air as possible is trapped inside the bag in order to avoid false results by floating and/or lack of contact between the DUT and the ice-water.
将DUT封闭在一个清洁的塑料袋内。保证袋内的空气尽可能少，以避免由于漂浮和/或DUT和冰水间接触不良而引起的错误结果。 b. Pre-cool the DUT in water at less than +3.0°C before immersing it in the bath. Pre-cooling the DUT reduces the time to reach equilibrium at the ice point; it also helps to preserve the bath at the ice point for a prolonged time. Additionally it ensures that the water-ice interface will be in close contact with the DUT; negligible melting is important, otherwise the water film thickness between the DUT and the ice-water will increase and distort the test results.
在浸入冰水浴中前将DUT放在低于+3.0°C的水中预冷。这样能降低达到冰点的平衡时间，它还有助于延长冰浴保持在冰点的时间。还有它确保冰水界面会与DUT紧密接触，微小的融化都是很重要的，否则DUT与冰水之间的水膜厚度会增加和扭曲测试结果。 c. Form a well in the ice-water bath that has the dimensions and intended immersion depth of the DUT.
在冰水浴中形成一个井，使其尺寸和深度可以浸入DUT。 d. Insert the sealed DUT to a depth of at least ten object diameters or heights respectively below the surface. Keep the DUT a minimum of 30mm above the bottom of the container in order to avoid the zone at the bottom where denser melt water tends to accumulate.
插入密封的DUT到至少10倍目标直径或表面以下高度。保持DUT至少比容器底部高出30mm，以避开底部比重大的水沉积的区域。 e. Replace the lid. For devices with an external sensor, make sure that the lid seals well around the sensor lead.
更换盖子。对于具有外部感应器的装置，保证盖子在感应器线的周围密封良好。 f. Allow the bath and DUT to come to thermal equilibrium. Allow for the thermal time constant of the DUT.
让冰浴和DUT达到热力学平衡。可以获取DUT的热力学时间常数。
Figure 2 – Ice-water bath arrangement 图2---冰水浴示意图
2.2.4 Carrying out the accuracy check, step-by-step 实施准确度检查，逐步进行 a. Establish and maintain the ice-water bath, prove its temperature with the reference thermometer.
建立并维护一个冰水浴，用标准温度计证明其温度。 b. Ensure that the DUT remains immersed in the ice-water bath as described in point 3.3d above.
保证DUT如上3.3d所述保持浸在冰水浴中 c. Directly read the DUT temperature display while it is still immersed in the bath. If this is not possible, remove the DUT and immediately read its temperature indicator; prompt action avoids false readings due to exposure to the ambient temperature.
保持DUT浸在冰水浴中直接读取DUT温度显示值。如果无法读取，则将DUT取出，立即读取其温度显示值。动作要快，以避免由于暴露在室温中而产生错误的读数。 d. Record the readings on a accuracy check reference data chart as per sample taken from EVM-SOP-E2-2. Store the chart at least until the next accuracy check takes place, and preferably for a minimum of three years.
按EVM-SOP-E2-2所举例，将读数记录在对照数据表中，将图表至少保存至下次准确度检查时，最好是保存至少三年。 2.2.5 Maintaining the bath temperature 保持浴槽温度 a. As ice particles in the bath melt, excess water begins to accumulate. This melt water has a temperature slightly above 0.0°C. Since the density of water is at its maximum at +4.0°C, the slightly warm melt water will collect at the bottom of the bath and, hence, around the DUT. Under these conditions, the bath will no longer be at 0.0°C and cannot serve as an ice-point bath. For this reason surplus water should be removed, as it accumulates, from the bottom of the bath by decanting or siphoning. The presence of excess water can be detected if water overspill occurs when the ice is depressed. Add ice particles, and chilled water, as necessary so that the ice slush column always extends to at least 30mm below the lowest point of the test object.
由于浴槽里的冰粒融化，浴槽里开始累积多余的水。这些融化的水温度略高于0.0°C.由于水的密度在+4.0°C时最大，融化后的水略温时会集中在浴槽的底部，这样就会围绕在DUT的周围。因此，当多余的水累积时，需要采用倾析或虹吸方式将其从浴槽底部除去。通过冰陷下或水超出的情况，可以发现水超量了。必要时加入冰粒和冷水，这样冰泥体积保持在受测装置最低点以下至少30mm处。 b. In order to sustain the ice point over prolonged periods, the ice-point bath can be immersed in another larger insulated bath that is kept near to 0.0°C.
为了在延长的时间段均能保持冰点，冰点浴可以浸在另一个更大的保持在接近0.0°C的绝热浴槽中。 2.2.6 Actions to take following the test 测试后操作 There are two possible test outcomes: pass or fail. 测试可能出现两种结果：合格和不合格。 1. The DUT passes the test 合格 A pass is achieved if the DUT temperature indication deviates from the reference thermometer reading[3] by less than the tolerance allowed in the data sheet. In this case the DUT should be physically labelled as follows: 如果DUT温度显示值与标准温度计读数小于数据表里允差值，则该DUT判定合格。此时，要对DUT标识如下： Accuracy valid until: <enter the date one year after the accuracy check>. 准确度有效期至：准确度检查后1年的日期 Note: If the manufacturer or the regulatory authority stipulates a shorter or longer period of validity, enter the appropriate date to take account of this. 注：如果生产商或法规当局给定了一个更短或更长的有效期，则据此输入适当的日期。 After this period expires the accuracy check must be repeated, as described in this document. 在准确度检查有效期超过后，必须按本文件所述重复检查。 2. The DUT fails the test 不合格 If the DUT temperature indication deviates from the reference thermometer reading[4] by more than the tolerance allowed in the data sheet. In this case, take one of the following actions: 如果DUT温度显示与标准温度计读数偏差超过了数据表中的允差，则认为其不合格。在此情况下，应采取以下措施之一： a. If the sensor can be adjusted, carry out the adjustment according to the manufacturer's instructions. Then repeat the accuracy check according to the procedure described above.
如果感应器可以调整，则根据生产商的指示来进行调整。这时要根据上述程序重复进行准确度检查。 b. If the sensor can be replaced, but the accuracy of the device is not solely dependent on the performance of the sensor head, replace the sensor according to the manufacturer's instructions. Then repeat the accuracy check.
如果感应器可以更换，但装置的准确度并不只取决于感应头的性能，则应根据生产商的指示来更换感应器，然后重复准确度检查。 c. If the sensor can be replaced, and the accuracy of the device depends entirely on the performance of the sensor head, the sensor can simply be replaced with a new factory-calibrated sensor in accordance with the manufacturer’s instructions. No further check is then required until the next accuracy/calibration date falls due.
如果感应器可以更换，且装置的准确度完全取决于感应头的性能，可以根据生产商的指示将感应器换成一个新的工厂校正过的新感应器。这时到准确度/校正到期时就不需要进一步检查。 d. If the sensor can neither be replaced nor adjusted, the whole DUT must be replaced and a non-conformity report must be issued to the relevant decision makers in order to ensure that the DUT is removed from service and replaced.
如果感应器既不能更换也不能调节，则要对整个DUT进行更换，必须签发不符合性报告给相关决策方，以保证DUT从服务中除去和更换。 References 参考文献 l ASTM E563-11 Standard Practice for Preparation and Use of an Ice-Point Bath as a Reference Temperature l ASTM E563-11 作为标准温度的冰点浴的制备和使用标准规范 l EN 12830:1999 Temperature recorders for the transport, storage and distribution of chilled, frozen, deep-frozen/quick-frozen food and ice cream. Tests, performance and suitability. l EN 12830-11:1999 低温、冷冻、深冷/快速冷冻食品和冰淇淋贮运和销售用温度记录仪，测试、性能和稳定性 l IEC 60529: Consolidated Edition 2.1 (incl. am1): Degrees of protection provided by enclosures (IP Code). l IEC 60529：合集版本2.1（包括AM1）：保护程度（IP代码） l WHO EVM-SOP=E2-2：温度监测装置准确度检查 l WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceuticalhttp://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf l WHO第961号技术报告，附录9：对时间和温度敏感的药品的贮运指南
Annex 1 - Generic temperature accuracy check form Store location: …………………………………………………………………………...... Form start date: ………………………………………………………………………….... Form finish date: .………………………………………………………………………….. Date | Device description | Device location | Reference thermometer | Check method | Reference temperature | Difference from reference | Initials | Comments | Verified by/ date | 12 Dec 2013 | DUT #12341234 | Cold room # 1 | XYZ 500 | Water-ice bath | 0.0°C | +0.2°C | UK | checked - OK | SJ 15 Dec2013 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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