風(fēng)險(xiǎn)分析簡表

1、Risk Analysis公司名稱Company:產(chǎn)品名稱Product:Risk Management風(fēng) 險(xiǎn) 管 理企業(yè)名稱：Company Name:企業(yè)地址：Company Address:產(chǎn) 品：Product:型 號(hào)：Model:附 件:Accessories:標(biāo) 準(zhǔn)：Standard：結(jié) 論：Result:所有可識(shí)別的風(fēng)險(xiǎn)都已經(jīng)被評(píng)估。在采取適當(dāng)?shù)拇胧┮越档瓦@些風(fēng)險(xiǎn)之后，關(guān)于產(chǎn)品預(yù)期的應(yīng)用和用途上，各種等級(jí)的風(fēng)險(xiǎn)是可以接受的。All risks associated with the identified hazards have been evaluated. After app

2、ropriate measures to reduce these risks have been taken, the overall level of risk of the product is acceptable with regard to the intended application and use of the application.編寫Compiled by:(Name/Title/Dept.)日期Date:評(píng)審Reviewed by(Name/Title/Dept.) 日期Date: 批準(zhǔn)Approved by:(Name/Title/Dept.)日期Date:特征的

3、定性定量分析： (acc. to ISO 14971:2000, cl. 4.2)Identification of qualitative and quantitative characteristics (acc. to ISO 14971:2000, cl. 4.2)1預(yù)期用途和怎樣使用：Intended use and how to use2是否接觸病人或其他人：Intended to contact patient or other person3所用的元件/材料：Materials/components used4能量給予/源于病人：Energy to/from patient5物

4、質(zhì)給予/源于病人：Substances to /from patient6被加工的生物材料：Biological materials processed7滅菌/用戶滅菌或其它微生物控制：Sterile/Intended to be sterilized8用戶是否需日常清潔或消毒：Routinely cleaned and disinfected by the user9改變病人環(huán)境：Modify patient environment10測(cè)量功能：Measurements11器械輸出的數(shù)據(jù)解釋：Interpretative12是否與其它藥物或醫(yī)療技術(shù)聯(lián)用：Use in conjunction

5、with medicines or other medical technologies13不需要的能量或物質(zhì)輸出：Unwanted outputs of energy or substances14受環(huán)境影響:（操作、運(yùn)輸?shù)拇鎯?chǔ)的環(huán)境，包括溢出，電能和冷卻提供）Susceptible to environmental influences15器械是否影響環(huán)境Influence the environment16基本消耗品/附件Consumables/accessories associated17是否需要維護(hù)或校正Routine maintenance/calibration18是否包括軟件

6、Software19是否有嚴(yán)格的壽命周期Restricted “shelf-life”:20延長/長期使用的影響Delayed and/or long-term use effect21使用者或病人對(duì)器械機(jī)械力控制Mechanical forces 22決定器械的壽命（包括老化）Lifetime of the device determined 23一次性/重復(fù)使用Single use/re-use24是否需安全退出運(yùn)行或處置Safe decommissioning or disposal25安裝和使用是否需特殊培訓(xùn)Special training required to install or

7、 use26新生產(chǎn)過程是否需建立或引入new manufacturing processes need to be established or introduced27是否器械的成功使用，決定性的取決于人為因素，如用戶接口Successful application of the medical device critically dependent on human factors, such as user interface27.1醫(yī)療器械是否有連接部分或附件Connecting parts or accessories27.2是否有控制接口Control interface27.3器

8、械是否顯示信息Display information27.4器械是否由萊單控制Controlled by a menu28器械是否可移動(dòng)或可攜帶式To be mobile or portableLetters in the first column refer to ISO 14971:2000, cl. 4.2.其它重要的特征page 16 of 16Risk Analysis公司Company：產(chǎn)品Products ：No.危害Hard風(fēng)險(xiǎn)評(píng)估Risk Evaluation減低風(fēng)險(xiǎn)措施Risk Reduction Measure證明EvidenceNHALOR總論 General詳細(xì)說明可

9、能的危害Identify hazardsSODRLD2. Energy Hazards 能量危害1電能 Electricity2熱 Heat3機(jī)械力 Mechanical force4離子輻射 Ionizing radiation5非離子輻射 Non-ionizing radiation6電磁場(chǎng) Electromagnetic fields7可移動(dòng)部件 Moving parts8懸浮物 Suspended masses9支持病人器械失敗 Patient support device failure10壓力(管壁破裂) Pressure(vessel rupture)11聲壓Acoustic p

10、ressure12振動(dòng) Vibration13磁場(chǎng) Magnetic fields(e.g. MRI)·D3. Biological hazards 生物危害1微生物污染 Bio-contamination2生物不相容 Bio-incompatibility3不正確的成份(化學(xué)組成) Incorrect formulation(chemical composition)4毒性 Toxicity5變態(tài)反應(yīng)性allergenicity6誘變性mutagenicity7致瘤性oncogenicity8致畸性teratogenicity9致癌性Carcinogenicity10再感染，交叉感

11、染Re-and/or cross-infection11致熱性pyrogenicity12不能保持衛(wèi)生安全I(xiàn)nability to maintain hygienic safety13降解 Degradation·D4. Environmental hazards and contributory factors 環(huán)境危害及其形成因素1電磁場(chǎng)electromagnetic fields2不充足的能量或冷卻提供 Inadequate supply of power or coolant 3對(duì)電磁干擾的敏感性Susceptibility to electromagnetic interf

12、erence4電磁干擾的發(fā)射Emissions of electromagnetic interference5不充足的能量提供 Inadequate supply of power6不充足的冷卻提供inadequate supply of coolant7儲(chǔ)存或操作偏離規(guī)定的外部環(huán)境條件Storage or operation outside prescribed environmental conditions8與其它器械不相容 Incompatibility with other devices9意外的機(jī)械危害 Accidental mechanical damage10廢棄物和/或器械

13、處置的污染 Contamination due to waste products and /or device disposalD5. Hazards resulting from incorrect output of energy and substances 不正確的能量和物質(zhì)輸出產(chǎn)生的危害1電能electricity2輻射radiation3音量volume4壓力pressure5醫(yī)療氣體的供應(yīng)supply of medical gases6麻醉劑的供應(yīng)supply of anaesthetic agentsD6. Hazards related to the use of the

14、device and contributory factors使用器械危害及其形成因素1不適當(dāng)?shù)臉?biāo)簽 Inadequate labeling2不適當(dāng)?shù)氖褂檬謨?cè)Inadequate operating instructions如：§ 附件技術(shù)規(guī)范不適當(dāng)inadequate specification of accessories§ 預(yù)使用檢查規(guī)范不適當(dāng)inadequate specification of pre-use checks§ 操作說明書過于復(fù)雜over-complicated operating instructions§ 服務(wù)和維修規(guī)范不適當(dāng)

15、inadequate specification of service and maintenance3由無經(jīng)驗(yàn)或未經(jīng)培訓(xùn)的人使用 Use by unskilled/untrained personnel4合理的可預(yù)見的錯(cuò)誤使用 Reasonably foreseeable misuse5不充分的副作用警告Insufficient warning of side effects6不充分的一次性使用器械重復(fù)使用后的可能危害 Inadequate warning of hazards likely with re-use of single use devices7不正確的測(cè)量和其它方面計(jì)量Inc

16、orrect measurement and other metrological aspects8與消耗品/附件/其它器械不相容 Incompatibility with consumables/accessories/other devices9銳邊、銳角sharp edges or pointsC7. Inappropriate, inadequate or over-complicated user interface (man/machine communication) 不正確、不充分或過于復(fù)雜的用戶介面 （人/機(jī)交流）1錯(cuò)誤或判斷錯(cuò)誤Mistakes and judgement

17、errors2重疊和認(rèn)知檢索錯(cuò)誤Lapses and cognitive recall errors3滑移和疏忽（精神或?qū)嶋H的）Slips and blunders (mental or physical)4違反或偏離說明書、程序等Violation or abbreviation of instructions, procedures, etc.,5復(fù)雜或混淆的控制系統(tǒng)Complex or confusing control system6含糊的或不清晰的醫(yī)療器械狀態(tài)Ambiguous or unclear device state7設(shè)置、測(cè)量或其它信息的含糊或不清晰的顯示Ambiguous

18、 or unclear presentation of settings, measurements or other information8結(jié)果的錯(cuò)誤呈顯示Mispresentation of results9視覺、聽覺或觸覺的不充分Insufficient visibility, audibility or tactility10動(dòng)作控制或?qū)嶋H狀態(tài)信息顯示的圖象不清Poor mapping of controls to action, or of displayed information to actual state11與現(xiàn)存設(shè)備相比，模式或圖象成問題Controversial mo

19、des or mappings as compared to existing equipmentD8. Hazards arising from functional failure, maintenance and ageing 功能性失效，維護(hù)、老化的危害和形成因素1錯(cuò)誤的數(shù)據(jù)轉(zhuǎn)換Erroneous data transfer2維護(hù)(包括維修后功能檢查技術(shù)參數(shù)不足)的技術(shù)參數(shù)不足或缺乏Lack of , or inadequate specification for maintenance including inadequate specification of post mainte

20、nance functional checks3不適當(dāng)?shù)木S護(hù) Inadequate maintenance 4缺乏決定器械壽命的因素決定Lack of adequate determination of end of device life 5缺少電氣/機(jī)械完整性 Loss of electrical / mechanical integrity6不適當(dāng)?shù)陌b(污染和/或器械損壞) Inadequate packaging(contamination and /or deterioration of the device )7重復(fù)使用或不正確的重復(fù)使用 re-use and / or Impr

21、oper re-use8由于重復(fù)使用使用造成的功能惡化（如液/氣路的逐漸閉塞、流阻、電導(dǎo)率的變化）Deterioration in function (e.g. gradual occlusion of fluid/gas path, or change in resistance to flow, electrical conductivity) as a result of repeated use.B2. Additional hazards to in vitro diagnostic medical devices 體外診斷醫(yī)療器械的額外危害1批次的不均勻性、批次和批次的不一致性Ba

22、tch inhomogeneity, batch-to-batch inconsistency2共同的干擾因素Common interfering factors3延期效應(yīng)Carry-over effects4樣本標(biāo)示錯(cuò)誤Specimen identification errors5穩(wěn)定性問題（在儲(chǔ)存中、運(yùn)輸中、使用中、容器第一次打開后）Stability problems (in storage, in shipping, in use, after first opening of the container)6與樣本的抽取、準(zhǔn)備及穩(wěn)定性問題Problems related to taking, preparation and stability of speciments7先決條件的不適當(dāng)技術(shù)規(guī)范Inadequate specification of prerequisites8不適當(dāng)?shù)脑囼?yàn)特性）Inadequate test characteristics生產(chǎn)后信息Post-production information生產(chǎn)后經(jīng)驗(yàn)Post-production experience:風(fēng)險(xiǎn)管理經(jīng)驗(yàn)的評(píng)審Review of risk management experience:Risk Analys