風險分析ISO149712007

1、Risk Analysis Report風 險 分 析 報 告公司名稱：Company Name:公司地址：Company Address:產(chǎn) 品：Product:型 號：Model:附 件:Accessories:標 準：Standard:EN ISO 14971：2007結(jié) 論：Result:所有可識別的風險都已經(jīng)被評估。在采取適當?shù)拇胧┮越档瓦@些風險之后，關(guān)于產(chǎn)品預期的應用和用途上，各種等級的風險是可以接受的。All risks associated with the identified hazards have been evaluated. After appropriate me

2、asures 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:評審Reviewed by(Name/Title/Dept.) 日期Date: 批準Approved by:(Name/Title/Dept.)日期Date:特征的定性定量分析： (ac

3、c. to ISO 14971:2007, Annex C.2)Identification of qualitative and quantitative characteristics (acc. to ISO 14971:2007, Annex C.2)以下條款，如果不適用就寫NA，適用就寫清楚條件，要用英文1預期用途和怎樣使用：Intended use and how to use2是否植入設備：Is implanted?3是否接觸病人或其他人：Intended to contact patient or other person4所用的元件/材料：Materials/componen

4、ts used5能量給予/源于病人：Energy to/from patient6物質(zhì)給予/源于病人：Substances to /from patient7被加工的生物材料：Biological materials processed8滅菌/用戶滅菌或其它微生物控制：Sterile/Intended to be sterilized9用戶是否需日常清潔或消毒：routinely cleaned and disinfected by the user10改變病人環(huán)境：Modify patient environment11測量功能：Measurements12器械輸出的數(shù)據(jù)解釋：Interpr

5、etative13是否與其它藥物或醫(yī)療技術(shù)聯(lián)用：use in conjunction with medicines or other medical technologies14不需要的能量或物質(zhì)輸出：Unwanted outputs of energy or substances15受環(huán)境影響:（操作、運輸?shù)拇鎯Φ沫h(huán)境，包括溢出，電能和冷卻提供）Susceptible to environmental influences16器械是否影響環(huán)境influence the environment17基本消耗品/附件Consumables/accessories associated18是否需要維

6、護或校正Routine maintenance/calibration19是否包括軟件Software20是否有嚴格的壽命周期Restricted “shelf-life”:21延長/長期使用的影響Delayed and/or long-term use effect22使用者或病人對器械機械力控制Mechanical forces 23決定器械的壽命（包括老化）Lifetime of the device determined 24一次性/重復使用Single use/re-use25是否需安全退出運行或處置safe decommissioning or disposal26安裝和使用是否需

7、特殊培訓Special training required to install or use27如何提供安全使用的信息Information for safe use28新生產(chǎn)過程是否需建立或引入new manufacturing processes need to be established or introduced29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 interface29

8、.1用戶界面的特征能導致使用錯誤User interface design features contribute to use error29.2是否在能因分心導致錯誤的環(huán)境中使用Used in distraction environment29.3醫(yī)療器械是否有連接部分或附件connecting parts or accessories29.4是否有控制接口control interface29.5器械是否顯示信息display information29.6器械是否由萊單控制controlled by a menu29.7是否由特殊人士使用Used by persons with spe

9、cial needs29.8是否通過用戶界面來開始(控制)動作Initiate user actions30器械是否提供警報系統(tǒng)Alarm system31故意的誤用Deliberately misused32器械是否持有患者的關(guān)鍵數(shù)據(jù)Data critical to patient care?33器械是否可移動或可攜帶式To be mobile or portable34器械的使用是否依賴基本性能 Depend on essential performance?Letters in the first column refer to ISO 14971:2007, Annex C.2其它重要

10、的特征以下的條款不適用也是NA，適用的要寫清楚條件。D2. Energy Hazards 能量危害1電能 Electricity2熱 Heat3機械力 Mechanical force4離子輻射 Ionizing radiation5非離子輻射 Non-ionizing radiation6電磁場 Electromagnetic fields7可移動部件 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

11、pressure12振動 Vibration13磁場 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(化學組成) Incorrect formulation(chemical composition)4毒性 Toxicity5變態(tài)反應性allergenicity6誘變性mutagenicity7致瘤性oncogenicity8致畸性teratogenicity9致癌性Carcinogenicity10再感染，交叉感染Re-a

12、nd/or cross-infection11致熱性pyrogenicity12不能保持衛(wèi)生安全Inability to maintain hygienic safety13降解 DegradationD4. Environmental hazards and contributory factors 環(huán)境危害及其形成因素1電磁場electromagnetic fields2不充足的能量或冷卻提供 Inadequate supply of power or coolant 3對電磁干擾的敏感性Susceptibility to electromagnetic interference4電磁干擾

13、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意外的機械危害 Accidental mechanical damage10廢棄物和/或器械處置的污染 Conta

14、mination 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supply of medical gases6麻醉劑的供應supply of anaesthetic agentsD6. Hazards related to the use of the device and

15、contributory factors使用器械危害及其形成因素1不適當?shù)臉撕?Inadequate labeling2不適當?shù)氖褂檬謨訧nadequate operating instructions如：§ 附件技術(shù)規(guī)范不適當inadequate specification of accessories§ 預使用檢查規(guī)范不適當inadequate specification of pre-use checks§ 操作說明書過于復雜over-complicated operating instructions§ 服務和維修規(guī)范不適當inadequate

16、specification of service and maintenance3由無經(jīng)驗或未經(jīng)培訓的人使用 Use by unskilled/untrained personnel4合理的可預見的錯誤使用 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不正確的測量和其它方面計量Incorrect meas

17、urement 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、不充分或過于復雜的用戶介面 （人/機交流）1錯誤或判斷錯誤Mistakes and judgement errors2重疊和認

18、知檢索錯誤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設置、測量或其它信息的含糊或不清晰的顯示Ambiguous or unclear

19、 presentation of settings, measurements or other information8結(jié)果的錯誤呈顯示Mispresentation of results9視覺、聽覺或觸覺的不充分Insufficient visibility, audibility or tactility10動作控制或?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)存設備相比，模式或圖象成問題Controversial modes or mapp

20、ings as compared to existing equipmentD8. Hazards arising from functional failure, maintenance and ageing 功能性失效，維護、老化的危害和形成因素1錯誤的數(shù)據(jù)轉(zhuǎn)換Erroneous data transfer2維護(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 maintenance funct

21、ional checks3不適當?shù)木S護 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/機械完整性 Loss of electrical / mechanical integrity6不適當?shù)陌b(污染和/或器械損壞) Inadequate packaging(contamination and /or deterioration of the device )7重復使用或不正確的重復使用 re-use and / or Improper re-use

22、8由于重復使用使用造成的功能惡化（如液/氣路的逐漸閉塞、流阻、電導率的變化）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Batch inhomog

23、eneity, batch-to-batch inconsistency2共同的干擾因素Common interfering factors3延期效應Carry-over effects4樣本標示錯誤Specimen identification errors5穩(wěn)定性問題（在儲存中、運輸中、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、準備及穩(wěn)定性問題Problems related to taking, prepara

24、tion and stability of speciments7先決條件的不適當技術(shù)規(guī)范Inadequate specification of prerequisites8不適當?shù)脑囼炋匦裕㊣nadequate test characteristics生產(chǎn)后信息Post-production information生產(chǎn)后經(jīng)驗Post-production experience:風險管理經(jīng)驗的評審Review of risk management experience:縮略詞：Abbreviations usedRE風險評估Risk EvaluationS嚴重程度Severity (10 非常

25、嚴重very severe, 1 不嚴重 not severe)O發(fā)生頻率Occurrence (10 經(jīng)常often, 1 不發(fā)生never)D可發(fā)現(xiàn)Detection (10 當風險發(fā)生時不可能發(fā)現(xiàn)impossible to detect before risk occurs, 1 當風險發(fā)生時一定可發(fā)現(xiàn)will be certainly detected before risk occurs)RL風險等級Risk Level = 嚴重性Severity × 發(fā)生頻率Occurrence × 可發(fā)現(xiàn)Detection 1-9: 可忽略的風險，不需進一步行動 neglec

26、table risk, no further actions; 9-24: 中等風險，建議預防措施 moderate: minimal risk, preventive action recommended; 25-48: 中等風險，要求預防措施 moderate risk, preventive action required; >48: 風險通常一般不可接受 risk is usually not acceptableRRM風險減少措施 Risk Reduction MeasureNH新危害發(fā)生New hazard generated (no/ yes - if yes, 如不可接受

27、，寫出危害號碼 then number of new hazard indicated)ALOR風險是否可接受 Acceptable Level of Risk評分標準（僅供參考）：EffectSEVERITY of EffectRanking傷害客戶或員工Injure a customer or employee10違反法律/法規(guī)Be illegal9使得產(chǎn)品的使用/維護不再適用Render product or service unfit for use8引起客戶的極度不滿Cause extreme customer dissatisfaction7導致局部故障Result in part

28、ial malfunction6產(chǎn)品性能下降, 引起客戶抱怨Cause a loss of performance which is likely to result in a complaint5產(chǎn)品性能有很小的下降Cause minor performance loss4能夠克服, 但令人討厭Cause a minor nuisance but can be overcome with no performance loss3對產(chǎn)品性能有微小影響, 但不被關(guān)注Be unnoticed and have only minor effect on performance 2沒有影響B(tài)e unnoticed and not affect the performance1PROBABILITY of Fai