Risk Analysis Form

Risk AnalysisCompany:Product:風(fēng) 險(xiǎn) 分 析公司名稱(chēng)：公司地址：產(chǎn) 品：型 號(hào)：標(biāo) 準(zhǔn)：ISO 14971:2000結(jié) 論：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。 地點(diǎn)、時(shí)間 編者（部門(mén)、職位） 批 準(zhǔn)人 特征的定性定量分析： (acc. to ISO 14971:2000, cl. 4.2)a)預(yù)期用途：Intended useb)是否接觸病人或其他人：Intended to contact patient or other personc)所用的元件/材料：Materials/components usedd)能量給予/源于病人：Energy to/from patiente)物質(zhì)給予/源于病人：Substances to /from patientf)被加工的生物材料：Biological materials processedg)滅菌/用戶(hù)滅菌或其它微生物控制：Sterile/Intended to be sterilizedh)病人環(huán)境改變：Modify patient environmenti)測(cè)量功能：Measurementsj)器械輸出的數(shù)據(jù)解釋?zhuān)篒nterpretativek)是否控制或影響其它器械或藥物：Control/interact with other devices or drugsl)不需要的能量或物質(zhì)輸出：Unwanted outputs of energy or substancesm)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 influencesn)消耗品/附件的規(guī)格Consumables/accessories associatedo)是否需要維護(hù)的校正Routine maintenance/calibrationp)是否包括軟件Softwareq)是否有嚴(yán)格的壽命周期Restricted“shelf-life”:r)延長(zhǎng)/長(zhǎng)期使用的影響Delayed and/or long-term use effects)使用者或病人對(duì)器械的機(jī)械力Mechanical forces t)決定器械的壽命（包括老化）Lifetime of the device determined u)一次性/重復(fù)使用Single use/re-useLetters in the first column refer to ISO 14971:2000, cl. 4.2.其它重要的特征page 3 of 8Risk Analysis公司：產(chǎn)品：No.危害風(fēng)險(xiǎn)評(píng)估減低風(fēng)險(xiǎn)措施證明NHALOR總論詳細(xì)說(shuō)明SODRLC2. 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 pressure12振動(dòng) Vibration13磁場(chǎng) Magnetic fields(e.g. MRI)C3. Biological hazards 生物危害1微生物量 Bio-burden2微生物污染 Bio-contamination3生物不相容 Bio-incompatibility4不正確的輸出(物質(zhì)./能量) Incorrect output(substance/energy)5不正確的成份(化學(xué)組成) Incorrect formulation(chemical composition)6毒性 Toxicity7交叉感染 (cross)-infection8熱源 Pyrogenicity9不能保持衛(wèi)生安全 Inability to maintain hygienic safety10降解 DegradationC4. Environmental hazards 環(huán)境危害1電磁干撓 magnetic interference2不充足的能量或冷卻提供 Inadequate supply of power or coolant 3冷卻限制 Restriction of cooling4規(guī)定的外部環(huán)境條件的操作可能性Likelihood of operation outside prescribed environmental conditions5與其它器械不相容 Incompatibility with other devices6意外的機(jī)械危害 Accidental mechanical damage7廢棄物污染 Contamination due to waste products and /or device disposalC5. Hazards related to the use of the device 使用器械危害1不充分的標(biāo)簽 Inadequate labeling2不充分的使用手冊(cè)Inadequate operating instructions3不充分的附件技術(shù)參數(shù)說(shuō)明 Inadequate specification of accessories4不充足的使用前規(guī)格檢查 Inadequate specification of pre-use checks5過(guò)于復(fù)雜的操作手冊(cè)O(shè)ver-complicated operating instructions6操作手冊(cè)沒(méi)有或分離Unavailable or separated operating instructions7由無(wú)經(jīng)驗(yàn)或未經(jīng)培訓(xùn)的人使用 Use by unskilled/untrained personnel8合理的可預(yù)見(jiàn)的錯(cuò)誤使用 Reasonably foreseeable misuse9不充分的副作用警告Insufficient warning of side effects10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 devices11不正確的測(cè)量和其它方面計(jì)量Incorrect measurement and other metrological aspects12不正確診斷 Incorrect diagnosis13錯(cuò)誤數(shù)據(jù)傳遞 Erroneous data transfer14結(jié)果的錯(cuò)誤呈遞 Mispresentation of results15與消耗品/附件/其它器械不相容 Incompatibility with consumables/accessories/other devicesC6. Hazards arising from functional failure, maintenance and ageing 功能不足，維護(hù)失敗，老化的危害1預(yù)期用途的特征或功能不充足Inadequacy of performance characteristics for the intended use2維護(hù)(包括功能檢查后技術(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 functional checks3不充足維護(hù) Inadequate maintenance 4決定器械壽命的因素缺乏Lack of adequate determination of end of device life 5缺少機(jī)械完整性 Loss of mechanical integrity6不充分包裝(污染和/或器械損壞) Inadequate packaging(contamination and /or deterioration of the device )7不正確的重復(fù)使用 Improper re-usepage 11 of 9Risk AnalysisCompany:Product:縮略詞：Abbreviations usedRE風(fēng)險(xiǎn)評(píng)估Risk EvaluationS嚴(yán)重程度Severity (9 非常嚴(yán)重very severe, 0 不嚴(yán)重 not severe)O發(fā)生頻率Occurrence (9 經(jīng)常often, 0 不發(fā)生never)D可發(fā)現(xiàn)Detection (9 當(dāng)風(fēng)險(xiǎn)發(fā)生時(shí)不可能發(fā)現(xiàn)impossible to detect before risk occurs, 0 當(dāng)風(fēng)險(xiǎn)發(fā)生時(shí)一定可發(fā)現(xiàn)will be certainly detected before risk occurs)RL風(fēng)險(xiǎn)等級(jí)Risk Level = 嚴(yán)重性Severity 發(fā)生頻率Occurrence 可發(fā)現(xiàn)Detection 1-9: 可忽略的風(fēng)險(xiǎn)，不需進(jìn)一步行動(dòng) neglectable risk, no further actions; 9-24: 中等風(fēng)險(xiǎn)，建議預(yù)防措施 moderate: minimal risk, preventive action recommended; 25-48: 中等風(fēng)險(xiǎn)，要求預(yù)防措施 moderate risk, preventive action requ