医疗电器检测

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GB 4706.8-2008家用和类似用途电器的安全.电热毯、电热垫及类似柔性发热器具的特殊要求

GB 4706.1-2005的该章用下述内容代替：本部分涉及家用和类似用途的、对床或人体进行加热的电热毯、电热垫及其他柔性器具的安全，器具的额定电压不超过250V。本部分也适用于随器具一起提供的控制装置。就实际情况而言，本部分所涉及的各种器具存在的普通危险，是在住宅和住宅周围环境中所有的人可能会遇到的。然而，一般说来本部分并未涉及：——无人照看的幼儿和残疾人使用器具时的危险；——幼儿玩耍器具的情况。

GB 50333-2013医院洁净手术部建筑技术规范

本规范适用于医院新建、改建、扩建的洁净手术部工程的设计、施工和验收。

YY 1413-2016离心式血液成分分离设备

本标准规定了离心式血液成分分离设备(以下简称设备)的术语和定义、要求、试验方法、标志、使用说明书和包装、运输、贮存。本标准适用于利用一次性配套耗材连接供血者，能够同时实现血液的采集、离心式血液成分分离、回输的设备。本标准不适用于以下产品：——非离心式血液分离的设备或耗材，例如挤压式分离或膜式分离(如分离膜或吸附膜等)的设备或耗材；——与本设备配合使用的管路、离心杯、离心袋等耗材附件；——自体血液回收设备；——医用离心机；——仅对血袋中血液进行处理的设备。

SN/T 3532.3-2016进出口家用和类似用途电器的安全技术要求 第3部分:电子坐便器

SN/T 3532的本部分规定了进出口电子坐便器的安全技术要求。本部分适用于以存储、干燥或者销毁方式处理人体排泄物的电子坐便器的安全，器具的额定电压不超过250 V。本部分也适用于普通坐便器一同使用的电子设备的安全。不作为一般家用，但对公众仍可能引起危险的坐便器，例如，在商店、轻工业和农场中由非的人员使用的坐便器也属于本部分的范围。本部分所涉及的坐便器存在的普通危险，是在住宅和住宅周围环境中所有的人可能会遇到的。一般来说本部分并未涉及幼儿玩耍器具的情况。本部分不适用于：——打算使用在经常产生腐蚀性或爆炸性气体(如灰尘、蒸汽或瓦斯气体)特殊环境场所的坐便器；——用化学方式处理人体排泄物的坐便器；——用燃烧方式处理人体排泄物的坐便器。1C-JP修改：本部分涉及以给用户带来舒适感或清洁感为目的的与坐便器一起使用的电气设备的安全，器具的额定电压不超过250 V。本部分也适用于存储、干燥或者销毁方式处理人体排泄物的电子坐便器。本部分所涉及的坐便器存在的普通危险，是在住宅和住宅周围环境中所有的人可能会遇到的。一般来说本部分并未涉及幼儿玩耍器具的情况。

CNS 13783-2-2013电磁相容性－家用电器、电动工具及类似装置之要求－第2 部：耐受力－产品族系

1.1 本标准规定运用电能之家用及其类似用途之电器、电动玩具及电动机驱动的工具之电磁耐受力，此等装置连接到相线及中性线的单相额定电压不超过250 V，其他装置则不超过480 V。此等装置可能含有电动机(马达)、加热元件或系含有此两种元件之组合，可以含有电机或电子电路，亦可能由交流电源、变压器、电池或任何其他的电源供电。非做为家用电器使用之设备，诸如商店人员使用之装置、轻工业用之装置以及农场使用之装置，仍然须要耐受力位准，因此只要包含在CNS 13783-1(CISPR 14-1)之内产品，均属于本标准的适用范围；此外尚包含下列产品。－ 家用之微波炉及提供饮食服务之微波炉。－ 用射频(r.f.)能量加热之烹调架及烹调炉、(单炉与多炉)电磁炉。－ 装有紫外线到红外光(含可见光)辐射器，做为个人护理用之家电产品。1.2 本标准不适用于下列产品。－ 照明用的设备。－ 专门设计予重工业使用之设备。－ 在建筑物内，固定电气设备内部之部分装置(诸如保险丝、断路器、电缆及开关等)。－ 在特殊超强电磁场所内所需要使用之设备，例如会出现高电磁场的地方(诸如广播发射台附近)，或在电力线会产生大脉冲的地方(诸如发电站等)。－ 收音机及电视机、声音及影像设备与电子乐器等，但玩具除外。－ 医疗电器。－ 个人电脑及其类似设备，但玩具除外。－ 无线电发射机。－ 专门设计在车辆内使用之装置。－ 婴儿照护设备。1.3 耐受力之要求涵盖0 Hz至400 GHz频率范围。1.4 设备在电磁现象中之相关安全影响，并不包含在本标准中，而是包含在其他的标准中，诸如CNS 3765(IEC 60335)之系列标准。设备的异常操作状况，不必纳入耐受力的考量(诸如试验时，在电子电路中模拟错误的现象等)。备考： 实际上，用于船舶及飞机上的装置，可能会需要额外的耐受力要求。1.5 针对本范围中之装置，本标准之目的在规定其耐受力要求，此等要求涉及连续性及瞬间性、传导性及辐射性之电磁扰动，当然亦包含静电放电等。此等要求可代表主要电磁耐受力要求。备考： 在特殊状况下，会发生干扰位准超过本标准规定试验值，在此种情况下，可能需要采用特殊缓和措施。

DIN EN 62083-2011医疗电气设备.放射性治疗规划系统的安全性要求(IEC 62083-2009);德文版本EN 62083-2009

This standard applies to the design, manufacture and some installation aspects of an radiotherapy treatment planning system (RTPS). It defines requirements to be complied with by manufacturers in order to provide protection against the occurrence of hazards for the patient.

BS EN 60601-2-29-2008+A11-2011医疗电气设备.放射疗法模拟器基本安全性和必要性能的详细要求

To be read in conjunction with BS EN 60601-1

BS EN 60601-2-57-2011医疗电气设备.用于治疗,诊断,监控和化妆/美学的非激光源设备的基本安全性和必要性能的特定要求

Replacement:This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipmentincorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiologicaleffects in humans or animals for therapeutic, diagnostic, monitoring,cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment(LS EQUIPMENT).This particular standard does not apply to equipment for sun tanning, for ophthalmicinstruments or for infant phototherapy.LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or withoutpower supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

BS EN 62083-2009医用电气设备.放射线疗法处理计划系统的安全性要求

This International Standard applies to the design, manufacture and some installation aspectsof a radiotherapy treatment planning systems(RTPS)– for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice;– that imports data either through input by the OPERATOR or directly from other devices;– that outputs data either in printed form for review or directly to other devices;– and which is intended to be– for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, byOPERATORS having the required skills and training;– maintained in accordance with the recommendations given in the INSTRUCTIONS FORUSE, and– used within the environmental and electrical supply conditions SPECIFIED in thetechnical description.

BS EN 62220-1-2-2007医学电气设备.数字X射线成像设备的特性.量子检测效率的确定.乳腺X射线摄影术用检测器

This part of IEC 62220 specifies the method for the determination of the DETECTIVE QUANTUMEFFICIENCY (DQE) of DIGITAL X-RAY IMAGING DEVICES as a function of AIR KERMA and of SPATIALFREQUENCY for the working conditions in the range of the medical application as specified bythe MANUFACTURER. The intended users of this part of IEC 62220 are manufacturers and wellequipped test laboratories.This Part 1-2 is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for mammographicimaging such as but not exclusively, CR systems, direct and indirect flat panel detector basedsystems, scanning systems (CCD based or photon-counting). This part of IEC 62220 is notapplicable to– DIGITAL X-RAY IMAGING DEVICES intended to be used in general radiography or in dentalradiography;– computed tomography;and– devices for dynamic imaging (where series of images are acquired, as in fluoroscopic orcardiac imaging).NOTE The devices noted above are excluded because they contain many parameters (for instance, beamqualities, geometry, time dependence, etc.) which differ from those important for mammography. Some of thesetechniques are treated in separate standards (IEC 62220-1 and IEC 62220-1-3) as has been done for other topics,for instance for speed and contrast, in IEC and ISO standards.

BS EN 62220-1-3-2008医疗电气设备.数字X射线成像装置的特性.探测量子效率的测定.动态成像用探测器

This part of IEC 62220 specifies the method for the determination of the DETECTIVE QUANTUMEFFICIENCY (DQE) of DIGITAL X-RAY IMAGING DEVICES as a function of AIR KERMA and of SPATIALFREQUENCY for the working conditions in the range of the medical application as specified bythe MANUFACTURER. The intended users of this part of IEC 62220 are manufacturers and wellequipped test laboratories.This Part 1-3 is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for dynamic imagingsuch as, but not exclusively, direct and indirect flat panel-detector based systems.It is not recommended to use this part of IEC 62220 for digital X-RAY IMAGE INTENSIFIER-basedsystems.NOTE 1 This negative recommendation is based on the low frequency drop, vignetting and geometrical distortionpresent in these devices which may put severe limitations on the applicability of the measurement methodsdescribed in this standard.This part of IEC 62220 is not applicable to:– DIGITAL X-RAY IMAGING DEVICES intended to be used in mammography or in dentalradiography;– COMPUTED TOMOGRAPHY; and– systems in which the X-ray field is scanned across the patient.NOTE 2 The devices noted above are excluded because they contain many parameters (for instance, beamqualities, geometry, time dependence, etc.) which differ from those important for dynamic imaging. Some of thesetechniques are treated in separate standards (IEC 62220-1 and IEC 62220-1-2).

BS EN 62233-2008家用电器和类似用途器具有关人体辐射的电磁场测量方法

This International Standard deals with electromagnetic fields up to 300 GHz and definesmethods for evaluating the electric field strength and magnetic flux density around householdand similar electrical appliances, including the conditions during testing as well as measuringdistances and positions.Appliances may incorporate motors, heating elements or their combination, may containelectric or electronic circuitry, and may be powered by the mains, by batteries, or by any otherelectrical power source.Appliances include such equipment as household electrical appliances, electric tools andelectric toys.Appliances not intended for normal household use but which nevertheless may beapproached by the public, or may be used by laymen, are within the scope of this standard.This standard does not apply to:– apparatus designed exclusively for heavy industrial purposes;– apparatus intended to be part of the fixed electrical installation of buildings (such as fuses,circuit breakers, cables and switches);– radio and television receivers, audio and video equipment, and electronic musicinstruments;– medical electrical appliances;– personal computers and similar equipment;– radio transmitters;– apparatus designed to be used exclusively in vehicles;The fields of multifunction equipment which is subjected simultaneously to different clauses ofthis standard and/or other standards shall be assessed using the provisions of eachclause/standard for the relevant functions in operation.Abnormal operation of the appliances is not taken into consideration.This standard includes specific elements to assess human exposure:– definition of sensor;– definition of measuring methods;– definition of operating mode for appliance under test;– definition of measuring distance and position.The measurement methods specified are valid from 10 Hz to 400 kHz. In the frequency rangeabove 400 kHz and below 10 Hz appliances in the scope of this standard are deemed tocomply without testing unless otherwise specified in IEC 60335 series.

BS EN 62494-1-2008医疗电气设备.数字X射线成像系统用曝光指数.一般X射线照相术用定义和要求

This part of IEC 62494 specifies definitions and requirements for the EXPOSURE INDEX ofimages acquired with DIGITAL X-RAY IMAGING SYSTEMS.This standard is applicable to DIGITAL X-RAY IMAGING SYSTEMS used in general radiography forproducing PROJECTION X-ray images for general applications, such as, but not exclusively:• computed radiography (CR) systems based on stimulable phosphors;• flat-panel detector based systems;• charge-coupled device (CCD) based systems.Image intensifier based systems and systems for mammographic or dental application are notcovered in this first edition.This standard defines the EXPOSURE INDEX only for images generated with a singleIRRADIATION event. Images generated from multiple IRRADIATIONS (e.g., tomosynthetic or dualenergyimages, multiple views on a single CR plate) are not covered.

KS C IEC 60601-1-3-2017医疗电器设备.第1部分:安全通用要求.第3节:附属标准.X射线诊断设备射线防护的总要求

​이 표준은 의료용 전기기기 및 의료용 전기 시스템의 기본 안전 및 필수 성능에 적용한다(이하 “ME 기기 및 ME 시스템”으로 표시함). 이 보조표준은 환자의 방사선학 영상에 있어 의료 절차의 진단, 계획 및 지침을 위하여 X선 장치와그 장치의 부조립품에 대하여 적용한다.​

KS C IEC 80601-2-35-2017医疗电器设备.第2-35部分:医疗保温的预订计划和毛毯、衬垫和坐垫安全的特殊要求.

​이 표준은 의료용 블랭킷, 패드 및 매트리스를 사용하는 전열장치(이하 “의료용 전기기기”라 함.)의 기본 안전성과 필수 성능에 적용한다. 침대를 예온하는 데 사용되는 전열장치는 이 표준의 적용범위에 포함된다. 어떤 절이나 항이 ME 기기에만 또는 ME 시스템에만 적용되도록 규정된 경우, 그 절이나 항의 제목과 내용에 그렇게 명시되어 있을 것이다. 그런 경우가 아니라면 그 절이나 항을 ME 기기와 ME 시스템에 모두 적용한다.​