醫(yī)療電器檢測

醫(yī)療電器檢測項目報價？??解決方案？??檢測周期？??樣品要求？

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GB 4706.8-2008家用和類似用途電器的安全.電熱毯、電熱墊及類似柔性發(fā)熱器具的特殊要求

GB 4706.1-2005的該章用下述內(nèi)容代替：本部分涉及家用和類似用途的、對床或人體進行加熱的電熱毯、電熱墊及其他柔性器具的安全，器具的額定電壓不超過250V。本部分也適用于隨器具一起提供的控制裝置。就實際情況而言，本部分所涉及的各種器具存在的普通危險，是在住宅和住宅周圍環(huán)境中所有的人可能會遇到的。然而，一般說來本部分并未涉及：——無人照看的幼兒和殘疾人使用器具時的危險；——幼兒玩耍器具的情況。

GB 50333-2013醫(yī)院潔凈手術部建筑技術規(guī)范

本規(guī)范適用于醫(yī)院新建、改建、擴建的潔凈手術部工程的設計、施工和驗收。

YY 1413-2016離心式血液成分分離設備

本標準規(guī)定了離心式血液成分分離設備(以下簡稱設備)的術語和定義、要求、試驗方法、標志、使用說明書和包裝、運輸、貯存。本標準適用于利用一次性配套耗材連接供血者，能夠同時實現(xiàn)血液的采集、離心式血液成分分離、回輸?shù)脑O備。本標準不適用于以下產(chǎn)品：——非離心式血液分離的設備或耗材，例如擠壓式分離或膜式分離(如分離膜或吸附膜等)的設備或耗材；——與本設備配合使用的管路、離心杯、離心袋等耗材附件；——自體血液回收設備；——醫(yī)用離心機；——僅對血袋中血液進行處理的設備。

SN/T 3532.3-2016進出口家用和類似用途電器的安全技術要求 第3部分:電子坐便器

SN/T 3532的本部分規(guī)定了進出口電子坐便器的安全技術要求。本部分適用于以存儲、干燥或者銷毀方式處理人體排泄物的電子坐便器的安全，器具的額定電壓不超過250 V。本部分也適用于普通坐便器一同使用的電子設備的安全。不作為一般家用，但對公眾仍可能引起危險的坐便器，例如，在商店、輕工業(yè)和農(nóng)場中由非的人員使用的坐便器也屬于本部分的范圍。本部分所涉及的坐便器存在的普通危險，是在住宅和住宅周圍環(huán)境中所有的人可能會遇到的。一般來說本部分并未涉及幼兒玩耍器具的情況。本部分不適用于：——打算使用在經(jīng)常產(chǎn)生腐蝕性或爆炸性氣體(如灰塵、蒸汽或瓦斯氣體)特殊環(huán)境場所的坐便器；——用化學方式處理人體排泄物的坐便器；——用燃燒方式處理人體排泄物的坐便器。1C-JP修改：本部分涉及以給用戶帶來舒適感或清潔感為目的的與坐便器一起使用的電氣設備的安全，器具的額定電壓不超過250 V。本部分也適用于存儲、干燥或者銷毀方式處理人體排泄物的電子坐便器。本部分所涉及的坐便器存在的普通危險，是在住宅和住宅周圍環(huán)境中所有的人可能會遇到的。一般來說本部分并未涉及幼兒玩耍器具的情況。

CNS 13783-2-2013電磁相容性－家用電器、電動工具及類似裝置之要求－第2 部：耐受力－產(chǎn)品族系

1.1 本標準規(guī)定運用電能之家用及其類似用途之電器、電動玩具及電動機驅(qū)動的工具之電磁耐受力，此等裝置連接到相線及中性線的單相額定電壓不超過250 V，其他裝置則不超過480 V。此等裝置可能含有電動機(馬達)、加熱元件或系含有此兩種元件之組合，可以含有電機或電子電路，亦可能由交流電源、變壓器、電池或任何其他的電源供電。非做為家用電器使用之設備，諸如商店人員使用之裝置、輕工業(yè)用之裝置以及農(nóng)場使用之裝置，仍然須要耐受力位準，因此只要包含在CNS 13783-1(CISPR 14-1)之內(nèi)產(chǎn)品，均屬于本標準的適用范圍；此外尚包含下列產(chǎn)品。－ 家用之微波爐及提供飲食服務之微波爐。－ 用射頻(r.f.)能量加熱之烹調(diào)架及烹調(diào)爐、(單爐與多爐)電磁爐。－ 裝有紫外線到紅外光(含可見光)輻射器，做為個人護理用之家電產(chǎn)品。1.2 本標準不適用于下列產(chǎn)品。－ 照明用的設備。－ 專門設計予重工業(yè)使用之設備。－ 在建筑物內(nèi)，固定電氣設備內(nèi)部之部分裝置(諸如保險絲、斷路器、電纜及開關等)。－ 在特殊超強電磁場所內(nèi)所需要使用之設備，例如會出現(xiàn)高電磁場的地方(諸如廣播發(fā)射臺附近)，或在電力線會產(chǎn)生大脈沖的地方(諸如發(fā)電站等)。－ 收音機及電視機、聲音及影像設備與電子樂器等，但玩具除外。－ 醫(yī)療電器。－ 個人電腦及其類似設備，但玩具除外。－ 無線電發(fā)射機。－ 專門設計在車輛內(nèi)使用之裝置。－ 嬰兒照護設備。1.3 耐受力之要求涵蓋0 Hz至400 GHz頻率范圍。1.4 設備在電磁現(xiàn)象中之相關安全影響，并不包含在本標準中，而是包含在其他的標準中，諸如CNS 3765(IEC 60335)之系列標準。設備的異常操作狀況，不必納入耐受力的考量(諸如試驗時，在電子電路中模擬錯誤的現(xiàn)象等)。備考： 實際上，用于船舶及飛機上的裝置，可能會需要額外的耐受力要求。1.5 針對本范圍中之裝置，本標準之目的在規(guī)定其耐受力要求，此等要求涉及連續(xù)性及瞬間性、傳導性及輻射性之電磁擾動，當然亦包含靜電放電等。此等要求可代表主要電磁耐受力要求。備考： 在特殊狀況下，會發(fā)生干擾位準超過本標準規(guī)定試驗值，在此種情況下，可能需要采用特殊緩和措施。

DIN EN 62083-2011醫(yī)療電氣設備.放射性治療規(guī)劃系統(tǒng)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醫(yī)療電氣設備.放射療法模擬器基本安全性和必要性能的詳細要求

To be read in conjunction with BS EN 60601-1

BS EN 60601-2-57-2011醫(yī)療電氣設備.用于治療,診斷,監(jiān)控和化妝/美學的非激光源設備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醫(yī)用電氣設備.放射線療法處理計劃系統(tǒng)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醫(yī)學電氣設備.數(shù)字X射線成像設備的特性.量子檢測效率的確定.乳腺X射線攝影術用檢測器

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醫(yī)療電氣設備.數(shù)字X射線成像裝置的特性.探測量子效率的測定.動態(tài)成像用探測器

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家用電器和類似用途器具有關人體輻射的電磁場測量方法

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醫(yī)療電氣設備.數(shù)字X射線成像系統(tǒng)用曝光指數(shù).一般X射線照相術用定義和要求

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醫(yī)療電器設備.第1部分:安全通用要求.第3節(jié):附屬標準.X射線診斷設備射線防護的總要求

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KS C IEC 80601-2-35-2017醫(yī)療電器設備.第2-35部分:醫(yī)療保溫的預訂計劃和毛毯、襯墊和坐墊安全的特殊要求.

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