輸液泵和控制器檢測(cè)

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GB 9706.224-2021醫(yī)用電氣設(shè)備 第2-24部分:輸液泵和輸液控制器的基本安全和基本性能專用要求

除下述內(nèi)容外，通用標(biāo)準(zhǔn)的第1章適用。替換：本文件規(guī)定了201.3.204，201.3.206，201.3.207，201.3.220，201.3.222和201.3.223的定義的腸內(nèi)營(yíng)養(yǎng)泵、輸液泵、便攜式輸液泵、注射/容器泵、容量式輸液控制器、容量式輸液泵的要求。本文件適用于輸液泵和容量式輸液控制器的基本安全及基本性能，以下簡(jiǎn)稱ME設(shè)備。由于輸注管路其本身的特性會(huì)影響到輸液泵和容量式輸液控制器的基本安全和基本性能，因此本文件一定程度上適用于輸注管路。然而，本文件并不會(huì)在輸注管路的其他方面做出規(guī)定的要求或者試驗(yàn)。如果一章或者一條明確指出僅適用于ME設(shè)備或者M(jìn)E系統(tǒng)，章或者條的標(biāo)題和正文會(huì)說明。如果不是這種情況，與此相關(guān)的章或條同時(shí)適用于ME設(shè)備和ME系統(tǒng)。除通用標(biāo)準(zhǔn)要求的條款7.2.13和8.4.1外，本標(biāo)準(zhǔn)范圍內(nèi)的ME設(shè)備或者M(jìn)E系統(tǒng)預(yù)期生理功能的固有危險(xiǎn)在本標(biāo)準(zhǔn)中沒有具體的要求。本文件不適用于下列設(shè)備：a)　專門用于診斷或類似用途的設(shè)備(例如，由操作者永久性控制或管理的血管造影或其他泵)；b)　血液的體外循環(huán)設(shè)備；c)　植入式設(shè)備；d)　專門用于尿動(dòng)力學(xué)診斷用的ME設(shè)備(利用導(dǎo)管將膀胱充滿水，測(cè)量其壓力-體積關(guān)系)；e)　專門用于男性陽痿檢測(cè)的診斷用的ME設(shè)備(為保持陰莖勃起，需維持一個(gè)預(yù)置壓力，測(cè)量為維持該壓力而注入的液體量：海綿體測(cè)量術(shù)、海綿體造影術(shù))；f)　由ISO 28620覆蓋的設(shè)備。

GB/T 31197-2014無機(jī)化工產(chǎn)品 雜質(zhì)陰離子的測(cè)定 離子色譜法

本標(biāo)準(zhǔn)規(guī)定了無機(jī)化工產(chǎn)品中雜質(zhì)陰離子測(cè)定用離子色譜法的術(shù)語和定義、方法原理、試劑、材料、儀器、儀器的安裝及操作方法、定性分析、定量分析、分析結(jié)果的表述、精密度等通用規(guī)則。本標(biāo)準(zhǔn)適用于離子色譜法對(duì)無機(jī)化工產(chǎn)品中各種雜質(zhì)陰離子(包括F<上標(biāo)->、C1<上標(biāo)->、Br<上標(biāo)->、I<上標(biāo)->、CN<上標(biāo)->、CO<下標(biāo)3><上標(biāo)2->、NO<下標(biāo)2><上標(biāo)->、NO<下標(biāo)3><上標(biāo)->、PO<下標(biāo)4><上標(biāo)3->、SO<下標(biāo)4><上標(biāo)2->、BrO<下標(biāo)3><上標(biāo)->、C1O<下標(biāo)4><上標(biāo)->、C1O<下標(biāo)3><上標(biāo)->、C1O<下標(biāo)2><上標(biāo)->、SCN<上標(biāo)->、N<下標(biāo)3><上標(biāo)->、AsO<下標(biāo)3><上標(biāo)3->、CrO<下標(biāo)4><上標(biāo)2->)進(jìn)行定量測(cè)定。

GB 50919-2013有色金屬冶煉廠節(jié)能設(shè)計(jì)規(guī)范

本規(guī)范適用于有色金屬冶煉廠新建、改建、擴(kuò)建項(xiàng)目的節(jié)能設(shè)計(jì)。

YY/T 0573.2-2018一次性使用無菌注射器 第2部分:動(dòng)力驅(qū)動(dòng)注射泵用注射器

YY/T 0573本部分規(guī)定了由高分子材料制成的公稱容量為5 mL及5 mL以上的動(dòng)力驅(qū)動(dòng)注射泵用注射器的要求，動(dòng)力驅(qū)動(dòng)注射泵用注射器應(yīng)與經(jīng)制造商確認(rèn)的注射泵配套使用。本部分不適用于胰島素注射器、玻璃注射器、由制造廠預(yù)裝藥液的注射器以及與藥液配套的注射器等。本部分不涉及注射藥液的兼容性。

YY/T 1291-2016一次性使用胰島素泵用皮下輸液器

本標(biāo)準(zhǔn)規(guī)定了由接口、管路和穿刺組件組成的胰島素泵用皮下輸液器（簡(jiǎn)稱“皮下輸液器”）的要求。該產(chǎn)品為一次性使用無菌產(chǎn)品。本標(biāo)準(zhǔn)不包括胰島素泵中充裝胰島素的器械（如儲(chǔ)藥器、預(yù)灌封卡式瓶）的要求。本標(biāo)準(zhǔn)不涉及皮下輸液器與胰島素泵配合時(shí)的流量控制的精度要求。

YY/T 1469-2016便攜式電動(dòng)輸液泵

本標(biāo)準(zhǔn)規(guī)定了便攜式電動(dòng)輸液泵(以下簡(jiǎn)稱便攜式輸液泵)的定義、基本要求和相應(yīng)的試驗(yàn)方法。本標(biāo)準(zhǔn)適用于醫(yī)療監(jiān)護(hù)環(huán)境下使用的便攜式電動(dòng)輸液泵；該產(chǎn)品預(yù)期用途為靜脈或硬膜外的鎮(zhèn)痛給藥。便攜式輸液泵主要由驅(qū)動(dòng)裝置、貯液裝置和輸液管路組成；貯液裝置和輸液管路為一次性使用部件。本標(biāo)準(zhǔn)不適用于以下設(shè)備：--專門用于診斷或者類似用途的設(shè)備(例如高壓注射器)；--腸胃給養(yǎng)泵；--用于血液體外循環(huán)的設(shè)備；--胰島素泵及相似臨床應(yīng)用的泵；--對(duì)輸液精度有特殊要求的便攜式輸液泵。

JJF 1259-2018醫(yī)用注射泵和輸液泵校準(zhǔn)規(guī)范

本規(guī)范適用于醫(yī)用注射泵(以下簡(jiǎn)稱注射泵)和醫(yī)用容量式輸液泵(以下簡(jiǎn)稱輸液泵)的校準(zhǔn)。

WS/T 118-1999衛(wèi)生行業(yè)藥療器械、儀器設(shè)備(商品、物資)分類與代碼

本標(biāo)準(zhǔn)規(guī)定了衛(wèi)生行業(yè)醫(yī)療器械、儀器設(shè)備（商品、物資）的分類與代碼。 本標(biāo)準(zhǔn)適用于衛(wèi)生行業(yè)各醫(yī)療、教學(xué)、科學(xué)研究和生物制品等單位對(duì)物資管理、計(jì)劃、統(tǒng)計(jì)及會(huì)計(jì)業(yè)務(wù)等使用。

JB/T 11924-2014稱量式液體添加系統(tǒng)

本標(biāo)準(zhǔn)規(guī)定了稱量式液體添加系統(tǒng)的術(shù)語和定義、型號(hào)命名和規(guī)格、要求、試驗(yàn)方法、檢驗(yàn)規(guī)則、標(biāo)志、包裝、運(yùn)輸和貯存。本標(biāo)準(zhǔn)適用于采用可預(yù)置重量值的稱重單元、自動(dòng)定量稱取液體后,用噴液泵為批次式飼料混合機(jī)添加液體的稱量式液體添加系統(tǒng)(以下簡(jiǎn)稱添加系統(tǒng))。

AS_NZS 3770-1993安全使用輸液泵和控制器的指南

This Standard provides advice on infusion pumps, infusion controllers, syringe pumps, and pumps for ambulatory use. These devices are intended to be used in hospitals for the administration of drugs or liquids to patients. In some circumstances they may be used by patients at home, under medical direction.This Standard does not apply to devices specifically intended for angiography, enteral infusion, or infusion of blood. Devices for extracorporeal circulation of blood including haemodialysis and plasmapheresis, or which are implanted in the body, are also excluded.In these specific cases refer to the manufacturer's operating instructions.NOTE: Because of the wide variation in use of these devices, this Standard can only address in general terms factors affecting their reliability or their intrinsic safety. The safe use of the infusion device is primarily the responsibility of the user. The user should therefore be trained in the correct selection of devices to ensure that the characteristics of the device chosen are appropriate for the treatment. The user should also be familiar with the operation of the device in accordance with the manufacturer's instructions.

IEC 60034-2-2-2010旋轉(zhuǎn)電機(jī).第2-2部分:試驗(yàn)中大型機(jī)械的分離損失測(cè)定用特殊方法.補(bǔ)充件IEC 60034-2-1

This part of IEC 60034 applies to large rotating electrical machines and establishes additionalmethods of determining separate losses and to define an efficiency supplementingIEC 60034-2-1. These methods apply when full-load testing is not practical and result in agreater uncertainty.NOTE In situ testing according to the calorimetric method for full-load conditions is recognized.The specific methods described are:– Calibrated-machine method.– Retardation method.– Calorimetric method.

GSO IEC 60601-2-24-2014醫(yī)用電氣設(shè)備第2-24部分：輸液泵和控制器基本安全和基本性能的特殊要求

Replacement: This Particular Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT. This standard applies to ADMINISTRATION SETS insofar as their characteristics influence the BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS. However this standard does not specify requirements or tests for other aspects of ADMINISTRATION SETS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This particular standard specifies the requirements for ENTERAL NUTRITION PUMPS, INFUSION PUMPS, INFUSION PUMPS FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220, 201.3.222 and 201.3.223. These particular standard does not apply to the following: a) devices specifically intended for diagnostic or similar use (e.g. angiography or other pumps permanently controlled or supervised by the OPERATOR); b) devices for extracorporeal circulation of blood; c) implantable devices; d) ME EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water); e) ME EQUIPMENT specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography); f) devices covered by ISO 28620.