ASTM E1112 电子体温计标准中文翻译

ASTM E1112 电子体温计中文翻译 1. Scope 1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. 此规格涵盖电子仪器用于间歇监测病人的温度。 1.2 This specification does not cover infrared thermometers.Specification E1965 covers specifications for IR thermometers. 本不包括红外温度计。规范E1965封面规格红外温度计。 1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 规定的值或者国际标准单位或英寸-磅单位分别被认为是标准。值表示在每一个系统可能不 确切等价物;因此,每个系统应独立使用的其他。从这两个系统结合值可能会导致不符合标准。 1.4 The following precautionary caveat pertains only to thetest method portion, Section 5, of this specification. This standard does not purport to address all of the safety concerns,if any, associated with its use. It is the responsibility of the users of this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 以下预防警告只适用于测验方法部分,第五节,这种规格的。这个标准的主旨不是处理所 有的安全问题,如果有的话,与其使用相关。它的职责是本标准的用户咨询和建立适当的安全 卫生标准并决定规章适用的限制使用前。 2. Referenced Documents 引用文件 3. Terminology 术语 3.1 Definitions: 3.1.1 The definitions given in Terminology E344 shall apply to this specification. 3.1定义: 3.1.1中给出的定义术语E344适用于本规范。 3.2 Definitions of Terms Specific to This Standard: 特定于本标准的术语定义: 3.2.1battery charger, n—electrical circuit designed to restore the electrical potential of a battery. 电池充电器，电路重新存储电池的电动势。 3.2.2distributor, n—any person who furthers the marketing of a device from the original manufacturer to the person who makes final delivery or sale to the ultimate consumer or user but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package. 经销商，N任何人展开装置从原始制造商谁作最后的交货或销售给最终消费者或用户却 不重新包装或更改容器，包装的个人营销，或标记的装置或设备包。 3.2.3electronic thermometer, n—instrument that provides a display of temperature sensed through the use of a transducer and electronic circuitry. 电子温度计，N的仪器，提供了一种显示温度检测通过使用一个传感器和电子电路。 3.2.4manufacturer, n—any person, including any repacker or relabeler, or both, who manufactures, fabricates, assembles, or reprocesses a finished device. (See “Good Manufacturing Practices,” Part 807 Code of Federal Regulations 6.) 制造商，任何人，包括任何分包商或再贴牌商，或两者，谁制造，制造，组装，或再加工 成品设备。(见“良好生产实践807部分，“联邦法规6码。) 3.2.5measurement time, n—that time required from the time of patient contact to display of temperature to within the stated accuracy. 测量时间，N，所需时间从患者接触到显示温度的时间内标定精度。 3.2.6predictive thermometer, n—one that provides an indication of the final stabilized temperature of the measurement site in advance of the time necessary for the transducer to reach a stabilized temperature. 预测温度计，不提供最终的稳定温度对传感器温度达到稳定所需的时间提前在测量现场 不可缺少的阳离子。 3.2.7probe, n—assembly, including the transducer, that is used to position the transducer in the specific location at which the temperature is to be determined. 探针，N组件，包括传感器，是用于在换能器的位置在特定的位置的温度是确定的。 3.2.8probe cover and sheath , n—device provided for the purpose of preventing biological contact between the patient and probe (see Specification E1104). 探头盖和护套，N装置为防止病人之间生物接触的目的和探针(见规范e1104)。 3.2.9IR thermometer , n—optoelectronic instrument that is capable of noncontact infrared temperature measurement when placed into the auditory canal of a subject (ear canal type) or from the subject’s body surface (skin type). 红外测温仪，N光电仪器，能够非接触红外温度测量时，放置在一个主体的耳道(耳道 式)或从主体的体表(皮肤型)。 3.2.10 transducer , n—device that provides a measurable output (for example, resistance, emf, etc.) as a function of temperature. 换能器，N装置，提供了一个可衡量的输出(例如，电阻，电动势，等)作为温度的函 数。 4. Requirements 要求 4.1 Temperature range —As a minimum, the instrument shall display temperature over the following range: 35.5 to 41.0?C [96.0 to 106.0?F]. 温度范围为最小，仪器会显示温度超过以下范围:35.5到41?C [ 96 ] 106?F。 4.2 Accuracy —Within the manufacturer’s specified tem-perature range for patient temperature measurement, no indi-vidual reading shall be in error by more than the values shown in Table 1. 在厂家指定的温度范围内，温度测量精度的病人，没有个体阅读应超过表1中显示的值是 错误的。 4.3 Environment: 环境 4.3.1Operating Environment—The instrument must meet the accuracy requirements of 4.2 when operated in an environ-ment of 16 to 40?C [60.8 to 104?F] and a relative humidity of 15 to 95 % noncondensing. 运行环境的工具必须满足4.2的精度要求，操作时，在16到40?C [ 60.8 ]和104?F 15至95% 相对湿度的环境背压。 4.3.2Storage Environment —The instrument shall meet the requirements of 4.2 after having been stored or transported, or both, at any point in an environment of ?20 to 50?C *?4 to 120?F], and a relative humidity of 15 to 95 %, noncondensing, for a period of one month. 存储环境仪器应经储存或运输，满足4.2的要求，或两者，在周围环境中的任何一点,20 to 50?C [?4到120?F ]，和15至95%的相对湿度，背压，期限为一个月。 4.3.3Labeling—The instruction manual shall include a statement that informs the user if the performance of the device may be degraded should one or more of the following occur: 标签说明书应包括一份声明，通知用户如果装置的性能会降低，应以下一个或多个发生: 4.3.3.1 Operation outside the manufacturer’s stated temperature and humidity range. 操作以外的制造商规定的温度和湿度范围。 4.3.3.2 Storage outside the manufacturer’s stated temperature and humidity range. 存储在制造商规定的温度和湿度范围。 4.3.3.3 Mechanical shock (for example, drop test). 机械冲击(例如，跌落试验)。 4.3.3.4 Patient temperature is below ambient temperature (operating environment see 4.3.1). 病人的温度低于环境温度(运行环境看4.3.1) 4.4 Resolution: 分辨率 4.4.1Analog Display: 模拟显示 4.4.1.1 Celsius Graduations—Celsius display thermometers shall be graduated in intervals of not greater than 0.1?C. All full-degree graduations shall be long time. Half-degree graduations may be long lines. All other graduations shall be short lines (see 4.4.1.3 ). As a minimum, appropriate numerals shall be at every full-degree graduation except the numeral 37, which is optional (see 4.4.1.5 ). Graduation lines shall be spaced at least 0.50 mm [0.02 in.] center to center. 摄氏温度计摄氏刻度显示应于不超过0.1?所有完整的学位毕业典礼要很长的时间间隔。 半度刻度可能长的线。所有其他的刻度应短线(见4.4.1.3)。作为最低要求，适当的数字应 在每一个完整的学位毕业除了数字37，它是可选的(见4.4.1.5)。刻度线应间隔至少0.50毫米 [ 0.02 ]中心。 TABLE 1 Maximum Error Temperature Ranges 表1温度范围内最大误差 Temperature Maximum Error 温度 最大的错误 Celsius Scale: 摄氏温标 Less than 35.8?C ?0.3?C 小于35.8?C 35.8?C to less than 37?C ?0.2?C 35.8?C小于37?C 37.0?C to 39.0?C ?0.1?C 37?C 至39?C Greater than 39.0?C to 41.0?C ?0.2?C 大于39?小于C 41?C Greater than 41.0?C ?0.3?C 大于41?C Fahrenheit Scale: 华氏温标: Less than 96.4?F ?0.5?F 小于96.4?F 96.4?F to less than 98.0?F ?0.3?F 96.4?F小于98?F 98.0?F to 102.0?F ?0.2?F 98?F至 102?F Greater than 102.0?F to 106.0?F ?0.3?F 大于102?F小于 106?F Greater than 106.0?F ?0.5?F 大于106?F 4.4.1.2 Fahrenheit Graduations —Fahrenheit display thermometers shall be graduated in intervals of not greater than 0.2?F. All full-degree graduations shall be long lines (see 4.4.1.3 and 4.4.1.5 ). Half-degree graduations may be long lines. All other graduations shall be short lines. Appropriate numerals shall be placed as a minimum at every even degree graduation. Graduation lines shall be spaced at least 0.55 mm [0.022 in.] center to center. 华氏温度计华氏刻度显示应于不超过0.2?F.满度刻度线应长间隔(见4.4.1.3和4.4.1.5)。半 度刻度可能长的线。All other graduations shall be short lines. 适当的数字应放置在每一个连毕 业最低程度。刻度线应间隔至少0.55毫米[ 0.022 ]中心。 4.4.1.3 Scales Graduation Marks—All short graduation lines shall not be less than 1.3 mm [0.05 in.] in length. All long graduation lines shall be no less than 25 % longer than the short lines. The lines shall be essentially straight and in line with the pointer. They shall not be wider than the spaces between the graduations, nor wider than 0.45 mm [0.018 in.] and shall not be narrower than 0.10 mm [0.004 in.]. 刻度刻度标记所有短刻度线不得小于1.3毫米[ 0.05 ]的长度。所有长刻度线应不少于25%比 短线更长。线可以是直线与指针的线。他们不应比在毕业典礼的空间更大，也不超过0.45毫 米宽的[ 0.018 ]。不得小于0.10毫米[ 0.004 ]。 4.4.1.4 Pointer Width —The pointer shall have a maximum width of one-half of the spacing between graduation marks (see 4.4.1.1 or 4.4.1.2 ). 指针的指针宽度应具有刻度间距之间的半最大宽度(见4.4.1.1或4.4.1.2)。 4.4.1.5 Reference Marking —The line at 37 ?C [98.6 ?F] may be designated by an arrow or other suitable mark. If a reference mark is used, the position shall be within a tolerance of one-half of the minimum graduated interval. 引用标记在37?C [ 98.6?F]的线可以用箭头或其他合适的标记指定。如果一个参考标记的 使用，位置应在误差最小的刻度间隔的一半。 4.4.2Digital Display: 数字显示 4.4.2.1 Resolution—The digital display shall have incremental steps of not more than 0.1?C or 0.1?F. 分辨率的数字显示应不超过0.1?C或0.1?F.渐进的步骤 4.4.2.2 Readability—At the outside surface of the instrument, the numerals shall appear to be at least 2.5 mm [0.1 in.] high and 1.5 mm [0.059 in.] wide and appear to be separated from one another by a space of at least 0.7 mm [0.027 in.]. 在仪器的外表面的可读性，数字会出现至少2.5毫米[ 0.1 ]。高和1.5毫米[ 0.059 ]。宽，似 乎是从一个由一个至少0.7毫米[ 0.027 ]在空间上分开。 4.5 Battery Condition—When battery operated, the instrument accuracy and condition shall not be affected by battery condition unless a continuous automatic indication of unreliable condition is provided. The indication of unreliable condition must be presented until the battery condition is corrected. When an instrument uses a rechargeable battery, a position indication shall be provided with the instrument system to indicate that the battery is charging. 电池状态时，电池操作，仪器的精度应不受电池的状态，除非提供连续的不可靠的情况 下自动指示。不可靠的条件的指示必须直到电池条件下的修正。当仪器使用可充电电池，位 置指示应配备的仪器系统表示电池正在充电。 4.6 Construction: 建设 4.6.1Electrical —The instrument and accessories (such as battery chargers) shall meet the electrical safety requirements of UL 544(see 5.3). 电子仪器和附件(如电池充电器)应符合UL 544的电气安全要求(见5.3) 4.6.2Material: 材料 4.6.2.1 Case Material —The case material of the instrument and nondisposable accessories shall withstand biological and physical cleaning without performance degradation (see 5.2). It shall also withstand dropping without presenting an electrical safety hazard. 外壳材料和仪器的非一次性的配件应能承受的生物和物理性能下降的情况下清洗(见 5.2)。它也将承受滴不呈现一个电气安全危险。 4.6.2.2 Patient Contact Materials—Those parts of the electronic thermometer system intended for contact with anatomical sites for the purpose of temperature measurement as specified by the manufacturer shall be nontoxic (see 5.3). 患者接触的材料和温度测量是由制造商指定的目的的解剖部位接触的电子温度计系统的 部分应当无毒(见5.3)。 4.7 Marking—All markings for purposes of identification or instruction must be clear and legible. Deterioration shall not occur when subjected to cleaning (see 5.2). 标记用于识别或教学用所有的标识必须清晰。退化不会发生时进行清洗(见5.2)。 4.7.1Instrument Marking—The instrument shall be marked with the manufacturer’s or distributor’s name, model designation, serial number or lot number (to indicate the specific period, not to exceed 90 days, in which the thermometer was calibrated) and temperature scale, Celsius or Fahrenheit. Celsius or Fahrenheit may be abbreviated. 标线仪仪器应标有制造商或经销商的名称，型号，系列号或批号(注明具体期间，不超过90 天，该温度计校准)和温标，摄氏或华氏。摄氏或华氏可以简写。 4.7.2Probe Marking—Detachable reusable probes shall be marked with at least the manufacturer’s or distributor’s name or identification and serial or lot number. 可拆卸的可重复使用的探针，探针标记至少应标注的制造商或经销商的名称或标识和序列 或批号。 4.7.3Operating Instructions—Operating instructions shall be provided on the instrument. When space requirements dictate, the operating instructions on the instrument may be brief if detailed operating instruction are also provided. 操作说明书操作说明书应提供的仪器。当空间要求决定，对仪器的操作指令可能短暂如果 还提供了详细的操作指令。 4.7.4Care and Use Instructions —Instructions for the care, use, and biological and physical cleaning of the instrument shall be provided. Proper use and application of special attachments, such as oral or rectal probes and probe covers, shall be indicated. The manufacturer shall provide instructions to decontaminate, following each use, any patient contact component not intended for single use. 护理和使用说明的护理，使用的仪器，生物和物理清洗应提供。正确使用和特殊附件的应 用，如口服或直肠探头和探头盖，应当注明。制造商应提供指示，净化，每次使用后，任何 病人接触部件不能单独使用。 4.7.5Health and Safety Hazard Marking— Notices shall be displayed on the instrument if possible. 健康和安全危险标记通知应尽可能显示在仪器。 4.7.5.1 Hazardous Environmental Safety Warning—If the instrument or accessories (such as battery charger) do not meet the requirements of UL 913, a warning label, as defined in UL 544, shall be placed on the instrument or accessory. 危险环境安全预警如果仪表或附件(如电池充电器)不符合UL 913的要求，警告标签， 定义UL 544，应放置在仪表或附件。 4.7.6Identification: 识别 4.7.6.1 In order that purchasers may identify products con-forming to all requirements of this specification, producers and distributors may include a statement of compliance in conjunction with their name and address on product labels, invoices, sales literature, and the like. The following statement is suggested when sufficient space is available: This thermometer conforms to all of the requirements established in ASTM standard E1112. Full responsibility for conformance of this product to the specification is assumed by (name and address of producer or distributor). 为了使购买者可以识别产品消费形成了本规范的所有要求，生产商和经销商可以包括合 规声明，连同他们的名字和地址，在产品标签上，发票，销售文学，等。下面的语句是建议 当足够的可用空间:这种温度计符合所有规定的要求在ASTM标准E1112。为该产品的规格一 致性的充分的责任承担(名称和生产商或经销商的地址)。 4.7.6.2 The following abbreviated statement is suggested when available space on labels is insufficient for the full statement: Conforms to ASTM E1112 (name and address of producer or distributor). 以下简称声明建议时，标签上的可用空间不足的完整声明:符合ASTM E1112(名称和生 产商或经销商的地址)。 4.8 Documentation: 文档 4.8.1Detailed Instructions—Detailed instructions for use shall be provided. These instructions shall contain sufficient detail to provide a means for training in the operation, application, care, and biological and physical cleaning of the instrument and accessories. 详细说明详细的使用说明应提供。这些说明应包含足够的细节来提供在运行，训练手段的 应用，护理，以及仪器和附件的生物和物理清洗 4.8.2Service and Repair Manual—A service manual shall be made available if user repair is permitted by the manufacturer. The service manual shall provide theory of operation, maintenance information, test procedures, test equipment requirements, detailed diagrams, parts list, and specifications. 服务和维修手册，维修手册应如果用户修复是由制造商允许使用。服务手册应提供操作 理论，维修信息，测试程序，测试设备的要求，详细的图，零件清单，和规格。 4.8.3Accuracy Determination—Manufacturer shall make available specific instructions for test to determine the accuracy of the instrument, including the temperature probe. Manufacturers of predictive thermometers must specify corrections to compensate for the difference between in vivo and vitro conditions if required (see 5.4.2). 制造商应提供准确的测定试验来确定仪表的精度的具体说明，包括温度探头。预测温度计 制造商必须如果需要指定补偿之间的差异在体内和体外条件下的修正(见5.4.2)。 4.8.4Recalibration—The manufacturer shall recommend a periodic recalibration cycle to ensure continuous performance to the requirements of 4.2. The manufacturer shall provide specific instructions for the adjustment of the instrument if user adjustment is permitted by the manufacturer. Test equipment or fixtures required for adjustment must either be described in sufficient detail to permit fabrication or purchase; or, manufacturer’s equipment or fixtures must be made available to users. 校准应推荐定期校准周期保证连续执行4.2的要求。制造商应提供具体说明了仪器的调整， 如果是由制造商允许用户调整。测试设备或装置所需的调整必须描述足够的细节来允许制造 或购买;或者，制造商的设备或设备必须提供给用户。 4.8.5Detailed Specifications The manufacturer shall pro-vide specifications of the instrument’s temperature range (see4.1), accuracy (see 4.2), and environment (see 4.3). 详细的规格，制造商应提供的仪器的温度范围规格(see4.1)，精度(见4.2)，环境(见4.3)。 5. Performance Tests 性能测试 5.1 Significance and Use —This section describes apparatus and procedures for verifying conformance to certain performance requirements of Section 4. These tests are not required of the manufacturer unless specified by the user. Verification procedures are not included for requirements that can be verified by observation or inspection, or where a standard procedure is not needed (such as the requirements of 4.4.1). The manufacturer shall certify that the product will comply with the requirements if tested in accordance with this section. With the exceptions of the potentially destructive tests, any single electronic thermometer shall be capable of undergoing the following tests in any sequence without impairment of performance. 意义和使用本节介绍了用于验证符合4节中的某些性能要求的设备和程序。不需要这些测 试的制造商，除非用户指定的。验证程序不包括要求，可通过观察或检查验证，或在一个标 准的程序是不需要的(如4.4.1要求)。制造商应该产品将如果按照本条测试符合要求。 具有潜在的破坏性试验的例外，任何单一的电子温度计应能接受任何序列以下测试没有减值 的性能。 5.2 Cleaning Tests—Perform the manufacturer’s recommended biological and physical cleaning procedures a minimum of five times. This shall result in no significant discoloration, detriment to operation, nor degradation of electrical safety. 清洗试验执行制造商推荐的生物和物理清洗程序至少五次。这将导致在没有明显的变色， 损害操作，也不降解的电气安全。 5.3 Toxicity Test—Test materials intended for patient con-tact in accordance with current issue of USP Biological Test-Plastic Container, Table 1(Extract of sample in sodium chloride and extract of sample in vegetable oil). 在美国药典生物测试塑料容器根据当前问题病人接触预期毒性测试材料，表1(在植物油 样品氯化钠提取样品提取物)。 5.4 Accuracy Test —Perform the following tests in accordance with manufacturer’s user procedures for measuring human temperatures. 精度测试执行以下检查制造商的用于测量人体温度按用户程序。 5.4.1Test Equipment—The test equipment includes a well stirred constant temperature liquid bath, the temperature of which is accurately calibrated within 0.03?C on the International Temperature Scale of 1990 as verified by a system whose calibration is traceable to The National Institute of Standards and Technology (NIST) or other appropriate national standards laboratory. The volume of the bath shall be no less than 1 L 试验设备试验设备包括一个搅拌好的恒温水浴，其温度被精确地校准在0.03?C对1990 国际温标由系统的校准可溯源到国家标准与技术研究所(NIST)验证或其他适当的国家标准 实验室。镀液的体积不得少于1升 5.4.2Test Method —Insert instrument probe and probe cover (if applicable) into liquid bath in accordance with manufacturer’s procedures. Accuracy requirements of 4.2 shall be met. Manufacturers of predictive type thermometers must specify corrections for liquid bath techniques to compensate for the difference between in vivo and vitro conditions if required and must so state in the labeling. 试验方法插入仪器探头和探头盖(如适用)为液体沐浴在制造商规定的程序。4.2的精度 要求应符合。预测式温度计制造商必须指定液池技术来弥补之间的差异在体内和体外条件下 如果需要更正必须在标签的状态。 5.5 Equipment Required for Environmental Test —A chamber having means for producing ambient temperature and relative humidity conditions described in 4.3and having means for limiting the rate of change of temperature to a maximum of 10?C [18?F] per minute shall be used. The chamber shall be of sufficient size to enclose the instrument under test completely, including charger and probe, if any. 所需设备环境试验室具有用于生产环境温度和相对湿度条件4.3and有描述限制温度变化 到最大10?C [ 18 ]?每分钟的速率应使用。室应具有足够的规模将在测试仪器完全，包括充 电器和探头，如果任何。 5.5.1Operating Environmental Tests —Expose the instrument, including probe and charger, if any, to the limits of operating environmental conditions described in4.3.1allowing a minimum of 4 h stabilizing time at each test condition before testing. Test in accordance with 5.5. Test conditions shall include but shall not be limited to the following: 操作环境试验暴露仪，包括探头和充电器，如果有的话，对作业环境条件的描述in4.3.1 允许在每个测试条件测试之前至少4小时的稳定时间的限制。5.5根据试验。试验条件应包括 但不限于以下: 5.5.1.1 Operating Environmental Test Conditions (see 4.3.1): 操作环境试验条件(见4.3.1): Condition 1 40?C, 15 % RH 条件1 40??，相对湿度15% Condition 2A 40?C, 80 % RH noncondensing 条件2 40?C，湿度80%背压 Condition 3 16?C, 40 % RH 条件3 16??，相对湿度40% Condition 4A 16?C, 95 % RH noncondensing 条件4 16?C，湿度95%背压 A Caution—To prevent condensation bring device to temperature prior to adding moisture to the chamber. 小心防止冷凝温度之前加入带装置湿气室 5.5.1.2 The rate of temperature change between test conditions shall be limited to a maximum of 10?C [18?F]/min to avoid thermal shock. 在试验条件下的温度变化率应限制在10?C [ 18 ]?F /分钟，避免热冲击。 5.5.1.3 Temperatures and relative humidities stated for test conditions in this section have a tolerance of +2 ?C and +5 % respectively. 温度和相对湿度表示在本节的试验条件有宽容的+ 2?C + 5%分别。 5.5.2Storage Environment Test Conditions —Expose the instrument including probe and charger, if any, to the limits of storage environment described in 4.3.2. Test conditions shall include but shall not be limited to the following: 存储环境的测试条件下暴露仪器包括探头和充电器，如果有，要存储环境中描述的4.3.2 的限制。试验条件应包括但不限于以下: 5.5.2.1 Storage Environment Test Conditions (see 4.3.1) 存储环境试验条件(见4.3.1) Condition 1 ?20?C, RH not applicable 条件1 零下20?C，湿度不适用 Condition 2A 50?C, 15 % RH 条件2 50??，相对湿度15% Condition 3 35?C, 95 % RH noncondensing 条件3 35?C，湿度95%背压 A Caution—To prevent condensation, bring device to temperature prior to adding moisture to the chamber. 要防止冷凝，使设备的温度之前增加水分的室 5.5.2.2 The rate of change of temperature between test conditions shall be limited to 10?C [18?F] per minute to avoid thermal shock. Maintain each test condition for the time duration described in 4.3.2. Remove from test conditions and packaging material and allow 24 h to stabilize to within the limits described in 4.3.1. Test in accordance with 5.5. 在试验条件下的温度变化率应限制在10?C [ 18 ]?每分钟以避免热冲击。保持每个测试 条件对时间描述4.3.2。从试验条件和包装材料，并允许24小时稳定在了4.3.1限制删除。5.5 根据试验。 5.5.2.3 Temperatures and relative humidities stated for test conditions in this section have a tolerance of 6 2?C and6 5% respectively. 温度和相对湿度表示在本节的试验条件下，有6的公差2和5%分别?C。 5.6 Precision and Bias—All test equipment specified in 5.4.1shall be sufficiently accurate so that test results produced with the equipment have an expanded uncertainty (k=3) not exceeding 0.045 ?C. 精密度和偏差的所有测试设备中指定的5.4.1shall足够准确，测试结果与设备产生的扩展 不确定度(K = 3)不超过0.045?C. 6. Keywords 关键词 6.1 clinical thermometers; electronic thermometers; intermittent determination of patient temperature 电子体温计;温度计;间歇测定病人体温 ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this standard. 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