临床用的体温测量温度计检测

发布时间：2024-06-21 作者：中析研究所浏览：

GB 12694-2016食品安全标准畜禽屠宰加工卫生规范

本标准规定了畜禽屠宰加工过程中畜禽验收、屠宰、分割、包装、贮存和运输等环节的场所、设施设备、人员的基本要求和卫生控制操作的管理准则。本标准适用于规模以上畜禽屠宰加工企业。

GB/T 21417.1-2008医用红外体温计.第1部分:耳腔式

GB/T 21417的本部分规定了耳腔式医用红外体温计的术语和定义、要求、试验方法、检验规则和标志、使用说明书、包装、运输、贮存。本部分适用于通过探测器测量与被测对象耳腔之间的红外辐射交换和适当的修正值，输出显示身体某部位温度的耳腔式医用红外体温计（以下简称体温计）。该体温计通过测量耳腔的热辐射来显示被测对象的体温。

GBZ/T 224-2010职业卫生名词术语

本标准规定了职业卫生术语的分类和定义或含义。本标准适用于职业卫生工作，特别是职业卫生标准的编写和实践。

YY/T 0734.1-2018清洗消毒器第1部分:通用要求和试验

YY/T 0734的本部分规定了自动控制的清洗消毒器及其附件的术语和定义、通用要求、试验方法、标志与使用说明书、包装、运输和贮存等。本部分适用于对可重复使用的医疗器械和对医疗机构等领域的物品进行清洁和消毒的清洗消毒器。处理特殊负载的清洗消毒器的要求和试验由YY/T 0734的其他部分或其他标准规定。

YY 0785-2010临床体温计连续测量的电子体温计性能要求

本标准规定了连续测量的电子体温计的性能要求。本标准适用于由电力驱动的设备，无论是用网电源还是内部电源供电。此设备能够装备附加的指示装置、打印装置和其他辅助装置。这些附件的要求不在本标准适用范围内。预期用于测量皮肤温度的温度计不在本标准适用范围内。本标准并不打算排除基于其他测量原理的设备的适用性，这些设备在连续测量人体温度时能获得等同的性能。注:设备可能包含一些适用于EN 12470的不同部分（见附录A)的功能。在这种情况下，制造商有责任指明哪些功能分别适用于EN 12470的哪些部分。例如：具有大温度记忆装置和可替换温度探头的电子体温计。

YY/T 0987.4-2016外科植入物.磁共振兼容性.第4部分:射频致热试验方法

YY/T 0987的本部分规定了磁共振成像(MRI)时无源植入物上或周围组织射频(RF)致热的试验方法。本部分试验方法是确定MR成像过程中医疗器械的存在是否会导致病人受伤的试验方法之一。其他需要说明的安全问题包括磁致位移力和扭矩及MR环境中医疗器械各种构型时的功能实现。在给定的特定吸收率(SAR)下，由射频引起的温度升高值取决于射频的频率，该频率又取决于静磁场强度。本部分中的试验方法侧重于1.5 T或3 T圆柱形MR系统，对其他静磁场强度的MR系统或磁体设计，可对本部分试验方法作适当修改以评价射频引起的温度升高。本部分试验假设是在植入物完全位于体内时进行。对于其他植入条件(如外固定设备、穿刺针、导管或系留设备如消融探头)，需对试验方法进行修改。本部分试验方法适用于带全身射频发射线圈的全身磁共振设备，其定义见YY 0319-2008中的2.2.103，全身射频发射线圈的定义见2.2.100。假定RF线圈是正交激发线圈。本部分采用单位制的数值作为标准，本部分不包含其他计量单位。

YY/T 1474-2016医疗器械可用性工程对医疗器械的应用

本标准规定了制造商分析、确定、设计、验证和确认可用性的过程，因为这关系到医疗器械的安全。可用性工程过程用于评定和降低由正确使用和使用错误等正常使用相关的可用性问题引起的风险。能用于识别但不用于评定或降低与非正常使用有关的风险。如果已经符合本标准中详细规定的可用性工程过程，并满足在可用性确认计划中形成文件的可接受准则(见5.9)，则假定ISO 14971中规定的与医疗器械可用性有关的剩余风险是可接受的，除非有相反的客观证据(见4.1.2)。本标准不适用于与医疗器械使用有关的临床决策。

JJF 1412-2013临床用变色体温计校准规范

本规范适用于测量范围为35.5 ℃~42.0 ℃用于测量人体温度的临床用变色体温计(以下简称体温计)的校准。

WS/T 367-2012医疗机构消毒技术规范

本标准规定了医疗机构消毒的管理要求；消毒与灭菌的基本原则；清洗与清洁、消毒与灭菌方法,清洁、消毒与灭菌的效果监测等。本标准适用于各级各类医疗机构。

EN 12470-1-2000临床温度计.第1部分:配备大器件的金属玻璃中液体体温计.包含修改件A1-2009

This part of EN 12470 specifies performance requirements and test methods for clinical liquid-in-glass thermometers with maximum device and applies only to thermometers filled with metallic liquid. NOTE 1 Note that in some European countries the use of mercury is prohibited in clinical thermometers. NOTE 2 Substances other than metallic liquids can be used in the manufacturing of liquid-in-glass thermometers. No reference is made to these inThis European Standard because there is no experience of clinical thermometers which use other substances.This European Standard does not apply to clinical thermometers designed for special applications (e. g. thermometers for premature babies, ovulation thermometers) which, owing to their measurement range, scale interval or maximum permissible error, fall outside the scope of this standard.

EN 12470-2-2000临床温度计.第2部分:相变型(点阵)温度计.包含修改件A1-2009

This part of EN 12470 specifies performance requirements and test methods for phase change-type (dot matrix)Thermometers for measuring temperature in body cavities. NOTE A body cavity can beThe mouth, rectum or armpit.This European Standard does not apply to clinicalThermometers designed for special applications (e. g.Thermometers for hypothermia) which owing toTheir measurement range, scale interval or maximum permissible error do not meetThe requirements specified inThis Standard.

DIN EN 12470-1-2009医用温度计.第1部分:带限位装置的玻璃式液体金属温度计.德文版本 EN 12470-1:2000+A1:2009

This Part of EN 12470 specifies performance requirements and test methods for clinical liquid-in-glassthermometers with maximum device and applies only to thermometers filled with metallic liquid.NOTE 1 Note that in some European countries the use of mercury is prohibited in clinical thermometers.NOTE 2 Substances other than metallic liquids can be used in the manufacturing of liquid-in-glass thermometers. Noreference is made to these in this European standard because there is no experience of clinical thermometers which useother substances.This European Standard does not apply to clinical thermometers designed for special applications (e.g.thermometers for premature babies, ovulation thermometers) which, owing to their measurement range, scaleinterval or maximum permissible error, fall outside the scope of this standard.

DIN EN 12470-2-2009临床体温计.相位变换式体温计(点矩阵),德文版本EN 12470-2:2000+A1:2009

This Part of EN 12470 specifies performance requirements and test methods for phase change-type (dotmatrix) thermometers for measuring temperature in body cavities.N~TE A body cavity can be the mouth, rectum or armpit.This European Standard does not apply to clinical thermometers designed for special applications (e.g.thermometers for hypothermia) which owing to their measurement range, scale interval or maximumpermissible error do not meet the requirements specified in this Standard.

DIN EN ISO 11073-00103-2017健康信息学. 个人保健装置通信. 第00103部分: 综述(ISO/IEEE 11073-00103-2015); 英文版本EN ISO 11073-00103-2017

Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e. g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.

BS EN 12470-1-2000+A1-2009医用体温计.第1部分:大装置玻璃管液体金属体温计

BS EN 12470-2-2000+A1-2009医用体温计.第2部分:相变型(点阵)温度计

This Part of EN 12470 specifies performance requirements and test methods for phase change-type (dotmatrix) thermometers for measuring temperature in body cavities.NOTE A body cavity can be the mouth, rectum or armpit.This European Standard does not apply to clinical thermometers designed for special applications (e.g.thermometers for hypothermia) which owing to their measurement range, scale interval or maximumpermissible error do not meet the requirements specified in this Standard.

BS EN 15758-2010文化遗产保护.气温和物体表面温度测量用仪器和规程

This European Standard recommends the procedures for measuring the temperature of the air and of thesurfaces of cultural property in indoor and outdoor environments, as well as specifying the minimumcharacteristics of instruments for such measurements.This document contains recommendations for accurate measurements to ensure the safety of objects and it isaddressed to any people with the responsibility of the environment, its diagnosis, the conservation ormaintenance of buildings, collections, or single object.

BS EN ISO 10414-1-2008石油和天然气工业.钻井泥浆的现场测试.第1部分:水基泥浆

This part of ISO 10414 provides standard procedures for determining the following characteristics ofwater-based drilling fluids:a) drilling fluid density (mud weight);b) viscosity and gel strength;c) filtration;d) water, oil and solids contents;e) sand content;f) methylene blue capacity;g) pH;h) alkalinity and lime content;i) chloride content;j) total hardness as calcium.Annexes A through K provide additional test methods which may be used for- chemical analysis for calcium, magnesium, calcium sulfate, sulfide, carbonate and potassium;- determination of shear strength;- determination of resistivity;- removal of air;- drill-pipe corrosion monitoring;- sampling, inspection and rejection;- rig-site sampling;- calibration and verification of glassware, thermometers, viscometers, retort-kit cup and drilling-fluidbalances;- permeability-plugging testing at high temperature and high pressure for two types of equipment;- example of a report form for water-based drilling fluid.

BS EN ISO 11073-10471-2011健康信息学.个人健康设备通信.装置化.独立存在活性中心

Within the context of the ISO/IEEE 11073 family of standards for device communication, this standardestablishes a normative definition of the communication between independent living activity hubs andmanagers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a mannerthat enables plug-and-play interoperability. It leverages appropriate portions of existing standards includingISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats,and behaviors in telehealth environments restricting ambiguity in base frameworks in favor ofinteroperability. This standard defines a common core of communication functionality for independentliving activity hubs. In this context, independent living activity hubs are defined as devices thatcommunicate with simple situation monitors (binary sensors), normalize information received from thesimple environmental monitors, and provide this normalized information to one or more managers. Thisinformation can be examined (for example) to determine when a person’s activities/behaviors havedeviated significantly from what is normal for them such that relevant parties can be notified. Independentliving activity hubs will normalize information from the following simple situation monitors (binarysensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chairoccupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personalemergency response system (PERS), and enuresis sensor (bed-wetting).