JJF(黔) 55-2021 电动颈腰椎牵引设备地方计量校准规范

贵州省市场监督管理局发布贵州省地方计量技术规范JJF（黔）55-2021电动颈腰椎牵引治疗设备校准规范CalibrationSpecificationforElectricCervicalandLumbarTractionTherapyDevice2021-11-XX发布2022-02-XX实施JJF(黔)55—2021电动颈腰椎牵引治疗设备校准规范CalibrationSpecificationforElectricCervicalandLumbarTractionTherapyDevice归口单位：遵义市市场监督管理局主要起草单位：遵义市产品质量检验检测院参加起草单位：贵州航天医院遵义医科大学第二附属医院本规范委托遵义市产品质量检验检测院负责解释JJF（黔）55—2021JJF(黔)55—2021本规范主要起草人：程宏（遵义市产品质量检验检测院）李明豫（遵义市产品质量检验检测院）李朴（遵义市产品质量检验检测院）杨衍宁（贵州航天医院）参加起草人：陈凤娟（遵义市产品质量检验检测院）朱丽（遵义市产品质量检验检测院）李广（遵义市产品质量检验检测院）董林铁（遵义医科大学第二附属医院）JJF(黔)55—2021I目录引言·······································································································································（II）1范围···································································································································（1）2引用文件···························································································································（1）3概述···································································································································（1）4计量特性···························································································································（2）4.1牵引力···························································································································（2）4.2计时·······························································································································（2）4.3角度牵引·······················································································································（2）5校准条件···························································································································（2）5.1环境条件·······················································································································（2）5.2测量标准和其他设备···································································································（3）6校准项目和校准方法·······································································································（3）6.1校准项目·······················································································································（3）6.2校准方法·······················································································································（3）7校准结果表达与处理·······································································································（5）8复校时间间隔···················································································································（6）附录A牵引力偏差校准结果的不确定度评定示例··························································（7）附录B计时偏差校准结果的不确定度评定示例····························································（10）附录C校准记录格式········································································································（13）附录D校准证书内页格式································································································（15）JJF(黔)55—2021II引言本规范依据JJF1071-2010《国家计量校准规范编写规则》、JJF1001-2011《通用计量术语及定义》、JJF1059.1-2012《测量不确定度评定与表示》、YY/T0697-2016《电动颈腰椎牵引治疗设备》编制。JJF(黔)55—20211电动颈腰椎牵引治疗设备校准规范1范围本规范适用于用电力驱动的通过牵引增加颈腰椎间隙以治疗颈腰椎病的电动颈腰椎牵引治疗设备（以下简称牵引治疗设备）的校准。本规范不适用于配合骨针等使用的骨牵引和快牵引设备。2引用文件本规范引用了下列文件：YY/T0697-2016电动颈腰椎牵引治疗设备凡是注日期的引用文件，仅注日期的版本适用于本规范；凡是不注日期的引用文件，其最新版本（包括所有的修改单）适用于本规范。3概述电动颈腰椎牵引治疗设备是使用电力为驱动，通过牵引力增加颈椎或腰椎间隙，并用力传感器、计时装置和控制系统来实时测量和控制牵引力大小和牵引治疗时间，以治疗颈腰椎疾病的设备，由牵引用椅（床）、力传感器、控制和显示装置、驱动电机、固定带及其他附件组成，其典型结构如图1和图2所示。图1电动颈椎牵引椅图2电动腰椎牵引床1、牵引用椅；2、固定带；3、立臂；4、控制和显示装置。1、牵引用床；2、固定带；3、控制和显示装置。JJF(黔)55—202124计量特性4.1牵引力4.1.1牵引力偏差牵引治疗设备牵引力实际输出值与预置值的偏差应不超过表1的规定。表1牵引力偏差牵引力F牵引力偏差F≤100N±10N100N＜F≤200N±10%200N＜F≤250N±20%F＞250N±50N4.1.2牵引力最大输出值牵引治疗设备牵引力最大输出值应不超过表2的规定。表2牵引力最大输出值牵引部位腰椎颈椎（卧姿）颈椎（坐姿）牵引力最大输出值1590N260N350N4.1.3牵引力变化速率牵引治疗设备牵引力变化速率应符合制造商规定。4.2计时牵引治疗设备总治疗时间计时偏差应符合制造商的规定，单个牵引相或间歇相的计时最大偏差应不大于±30s，单个渐进期或渐退期的计时最大偏差应不大于±2s。4.3角度牵引具有角度牵引功能的牵引治疗设备角度偏差应不大于±2°。4.4工作噪声牵引治疗设备在正常工作时的噪声应不大于60dB（A）。注：以上技术指标要求不用于合格性判定，仅供参考。5校准条件5.1环境条件JJF(黔)55—20213校准环境温度（20±5）℃，相对湿度≤80%。5.2测量标准及其他设备5.2.1测力仪，最大允许误差不超过±1.0%。5.2.2电子秒表，示值分辨力0.01s。5.2.3角度测量仪器，最大允许误差不超过±0.5°。5.2.4声级计，A计权网络。6校准项目和校准方法6.1校准项目校准项目一览表见表3。表3校准项目一览表序号校准项目名称校准方法的条款1牵引力偏差6.2.22牵引力最大输出值6.2.33牵引力变化速率6.2.44计时偏差6.2.55角度牵引偏差6.2.66工作噪声6.2.76.2校准方法6.2.1校准前准备校准前应先检查牵引治疗设备外观、显示和各部分相互作用，确定无影响计量特性因素后再进行校准。6.2.2牵引力偏差将测力仪安装在牵引治疗设备牵引工作位置上，设置牵引模式和牵引力，根据使用方需求选择常用的牵引力，其中牵引相牵引力还应包括最大可设置值的100%、50%和20%，启动牵引，达到设定牵引状态时，读取测力仪示值，按式（1）、式（2）计算牵引力偏差。ΔF＝f－F（1）JJF(黔)55—20214100fFFF（2）式中：ΔF——牵引力偏差，N（%）；f——测力仪示值，N；F——牵引治疗设备牵引力设定值，N。在牵引治疗设备具相应备功能的条件下，牵引力偏差的校准应包括连续牵引模式、间歇牵引模式的连续三个相邻牵引相和间歇相及其他需要校准的模式。6.2.3牵引力最大输出值将测力仪安装在牵引治疗设备牵引工作位置上，测力仪显示置于峰值模式，选择牵引模式，牵引力设置为最大可设置值，启动牵引，在整个牵引模式运行结束后，读取测力仪峰值示值为牵引力最大输出值。牵引力最大输出值应分别在牵引治疗设备具备的每种牵引模式下进行。6.2.4牵引力变化速率牵引力变化速率的校准可与6.2.3同时进行。在牵引过程的渐进期和渐退期，选择任意时刻为起点时刻，0.5s～1s后为终点时刻，分别记录起点时刻和终点时刻的测力仪示值，按式（3）计算牵引力变化速率。10FFvtΔ（3）式中：v——牵引力变化速率，N/s；F1——终点时刻测力仪示值，N；F0——起点时刻测力仪示值，N；Δt——时间间隔，s。牵引力变化速率的校准可采用拍照法，即分别在起点时刻和终点时刻对秒表和测力仪拍照且使秒表和测力仪处于同一画面中，以两张照片中记录的秒表和测力仪示值来计算牵引力变化速率。6.2.5计时偏差JJF(黔)55—20215设置牵引治疗设备牵引相、间歇相、渐进期、渐