| 編號(hào) | 中文名稱(chēng) | 英文名稱(chēng) |
|---|---|---|
| CR 13217-1998 | 用于常規(guī)數(shù)據(jù)交換的醫(yī)療設(shè)備的術(shù)語(yǔ)體系 基本原理 | Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale |
| CR 14060-2000 | 醫(yī)療設(shè)備示蹤能力 | Medical device traceability |
| CR 14230-2001 | 用于常規(guī)數(shù)據(jù)交換目的的全球醫(yī)療設(shè)備術(shù)語(yǔ)（ISO/TS 20225:2001） | Global medical device nomenclature for the purpose of regulatory data exchange (ISO/TS 20225:2001) |
| EN 1041-1998 | 廠商提供的醫(yī)療設(shè)備信息 | Information supplied by the manufacturer with medical devices |
| EN 1174-1-1996 | 醫(yī)療器械的消毒 產(chǎn)品的微生物群數(shù)的估算 第1部分：要求 | Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements |
| EN 1174-2-1996 | 醫(yī)療器械的消毒 產(chǎn)品的微生物總數(shù)的估算 第2部分：指南 | Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance |
| EN 1174-3-1996 | 醫(yī)療器械的消毒 產(chǎn)品的微生物總數(shù)的估算 第3部分：微生物技術(shù)確認(rèn)方法指南 | Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques |
| EN 12218-1998+A1-2002 | 醫(yī)療設(shè)備用護(hù)欄系統(tǒng) | Rail systems for supporting medical equipment |
| EN 12286-1998+A1-2000 | 體外診斷醫(yī)療器械 生物起源樣品中數(shù)量的測(cè)量 標(biāo)準(zhǔn)測(cè)量程序表達(dá) | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures |
| EN 12287-1999 | 體外診斷醫(yī)療器械 生物起源樣品中數(shù)量的測(cè)量 標(biāo)準(zhǔn)物質(zhì)描述 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials |
| EN 12322-1999+A1-2001 | 體外診斷醫(yī)療器械 微生物學(xué)用培養(yǎng)基 培養(yǎng)基的性能標(biāo)準(zhǔn) | In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media |
| EN 12376-1999 | 體外診斷醫(yī)療器械 由制造商提供的有關(guān)生物學(xué)染色用體外診斷劑的信息 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| EN 12442-1-2000 | 醫(yī)療設(shè)備制造中使用的動(dòng)物組織及其衍生物 第1部分：風(fēng)險(xiǎn)分析和管理 | Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk |
| EN 12442-2-2000 | 醫(yī)療設(shè)備制造中使用的動(dòng)物組織及其衍生物 第2部分：來(lái)源采集和處理的控制 | Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, collection and handling |
| EN 12442-3-2000 | 醫(yī)療設(shè)備制造中使用的動(dòng)物組織及其衍生物 第3部分：病毒和傳染性試劑消除和/或鈍化的驗(yàn)證 | Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents |
| EN 13532-2002 | 自檢用體外診斷醫(yī)療設(shè)備的一般要求 | General requirements for in vitro diagnostic medical devices for self-testing |
| EN 13612-2002+AC-2002 | 體外診斷醫(yī)療設(shè)備性能評(píng)估 | Performance evaluation of in vitro diagnostic medical devices |
| EN 13718-1-2002 | 空氣、水和困難場(chǎng)所救護(hù)車(chē) 第1部分：用于患者連續(xù)護(hù)理的醫(yī)療設(shè)備借口要求 | Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care |
| EN 13726-3-2003 | 非活動(dòng)醫(yī)療設(shè)備 原創(chuàng)口敷料試驗(yàn)方法 第3部分：防水性 | Non-active medical devices - Test methods for primary wound dressings - Part 3: Waterproofness |
| EN 13726-4-2003 | 非活動(dòng)醫(yī)療設(shè)備 原創(chuàng)口敷料試驗(yàn)方法 第4部分：合格性 | Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability |
| EN 13726-6-2003 | 非活動(dòng)醫(yī)療設(shè)備 原創(chuàng)口敷料試驗(yàn)方法 第6部分：氣味控制 | Non-active medical devices - Test methods for primary wound dressings - Part 6: Odour control |
| EN 13795-1-2002 | 作為醫(yī)療設(shè)備的患者、臨床材料和器材用外科手術(shù)用簾、長(zhǎng)袍和清潔氣衣 第1部分：.制造者、加工者和產(chǎn)品的一 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical stuff and equipment - Part 1: General requirements for manufacturers, processors and products |
| EN 13975-2003 | 體外診斷用醫(yī)療設(shè)備驗(yàn)收試驗(yàn)的取樣方法 統(tǒng)計(jì)法 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
| EN 14079-2003 | 非特效醫(yī)療設(shè)備 脫脂棉紗布、脫脂棉和粘膠紗布的性能要求和試驗(yàn)方法 | Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
| EN 14180-2003 | 醫(yī)療用消毒器 甲醛和低溫蒸氣消毒器 試驗(yàn)和要求 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| EN 1639-1996 | 牙科學(xué) 牙科用醫(yī)療設(shè)備 器械 | Dentistry - Medical devices for dentistry - Instruments |
| EN 1640-1996 | 牙科學(xué) 牙科學(xué)用醫(yī)療裝置 設(shè)備 | Dentistry - Medical devices for dentistry - Equipment |
| EN 1641-1996 | 牙科學(xué) 牙科用醫(yī)療裝置 材料 | Dentistry - Medical devices for dentistry - Materials |
| EN 1642-1996 | 牙科學(xué) 牙科用醫(yī)療裝置 牙科植入物 | Dentistry - Medical devices for dentistry - Dental implants |
| EN 1707-1996 | 注射器、針頭和其它醫(yī)療器械用有6%魯爾的錐形接頭 鎖緊接頭 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
| EN 20594-1-1993+A1-1997+AC-1996 | 注射器、針頭及其他醫(yī)療器械為6%（魯爾）的錐形接頭 第1部分：一般要求 | Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment; part 1: general requirements (ISO 594-1:1986) |
| EN 30993-3-1993 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第3部分:遺傳毒性、致癌性和生殖毒性試驗(yàn) | Biological evaluation of medical devices;-Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992) |
| EN 30993-6-1994 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第6部分:植入后局部反應(yīng)試驗(yàn) | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994) |
| EN 455-1-2000 | 一次性使用的醫(yī)療手套 第1部分：防洞要求和測(cè)試 | Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
| EN 455-2-2000 | 一次性使用的醫(yī)療手套 第2部分：物理性能的要求和測(cè)試 | Medical gloves for single use - Part 2: Requirements and testing for physical properties (including Technical Corrigendum 1:1996) |
| EN 455-3-1999 | 一次性使用的醫(yī)療手套 第3部分：生物評(píng)價(jià)的要求和測(cè)試 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| EN 45502-1-1997 | 活動(dòng)可植入醫(yī)療器件 第1部分：制造商提供的安全、 標(biāo)記和信息的一般要求 | Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer |
| EN 46003-1999 | 質(zhì)量體系 醫(yī)療設(shè)備 EN ISO 9003應(yīng)用的特殊要求 | Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003 |
| EN 475-1995 | 醫(yī)療設(shè)備 電氣報(bào)警信號(hào) | Medical devices - Electrically-generated alarm signals |
| EN 50103-1995 | 有源(包括有源可植入)醫(yī)療器械行業(yè)用ISO 9001/EN 46001和ISO 9002/EN 46002應(yīng)用指南 | Guidance on the application of ISO 9001 and EN 46001 and of ISO 9002 and EN 46002 for the active (including active implantable) medical device industry |
| EN 550-1994 | 醫(yī)療器械的消毒 用環(huán)氧乙烷消毒的確認(rèn)和常規(guī)控制 | Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization |
| EN 55011-1998+A1-1999+A2-2002 | 工業(yè)、科學(xué)、醫(yī)療（ISM）射頻設(shè)備 電磁騷擾特性 測(cè)量方法和限值 | Industrial, scientific and medical (ISM) radio-frequency equipment - Radio disturbance characteristics - Limits and methods of measurement (CISPR 11:1997, modified) |
| EN 55011/prA3-1998 | 工業(yè)、科學(xué)、醫(yī)療（ISM）射頻設(shè)備 電磁騷擾特性 測(cè)量方法和限值 修改prA3 | Amendment 3 to CISPR 11 |
| EN 55011/prAA-2002 | 工業(yè)、科學(xué)、醫(yī)療（ISM）射頻設(shè)備 電磁騷擾特性 測(cè)量方法和限值 修改prAA | Industrial, scientific and medical (ISM) radio-frequency equipment - Radio disturbance characteristics - Limits and methods of measurement |
| EN 55011/prAB-2002 | 工業(yè)、科學(xué)、醫(yī)療（ISM）射頻設(shè)備 電磁騷擾特性 測(cè)量方法和限值 修改prAB | Industrial, scientific and medical (ISM) radio-frequency equipment - Radio disturbance characteristics - Limits and methods of measurement |
| EN 55011/prAC-2002 | 工業(yè)、科學(xué)、醫(yī)療（ISM）射頻設(shè)備 電磁騷擾特性 測(cè)量方法和限值 修改prAC | Industrial, scientific and medical (ISM) radio-frequency equipment - Radio disturbance characteristics - Limits and methods of measurement |
| EN 552-1994+A1-1999+A2-2000 | 醫(yī)療器械的消毒 輻射消毒的確認(rèn)和常規(guī)控制 | Sterilization of medical devices - Validation and routine control of sterilization by irradiation |
| EN 554-1994 | 醫(yī)療器械的消毒 濕熱消毒的確認(rèn)和常規(guī)控制 | Sterilization of medical devices - Validation and routine control of sterilization by moist heat |
| EN 556-1-2001 | 醫(yī)療器械的消毒 標(biāo)明為“消過(guò)毒”的醫(yī)療器械的要求 第1部分：定期消毒的醫(yī)療器械的要求 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
| EN 60598-2-25-1994 | 燈具 第2部分：特殊要求 第25節(jié)：醫(yī)院和醫(yī)療保健中心臨床用燈具 | Luminaires - Part 2: Particular requirements - Section 25: Luminaires for use in clinical areas of hospitals and health care buildings (IEC 60598-2-25:1994 + Corrigendum 1994) |
| EN 60601-2-11-1997 | 醫(yī)療電氣設(shè)備 第2-11部分：γ射束治療設(shè)備安全專(zhuān)用要求 | Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997) |
| EN 60601-2-16-1998 | 醫(yī)療電氣設(shè)備 第2－16部分：血液透析、血液濾凈、血液濾過(guò)設(shè)備安全的特殊要求 | Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998) |
| EN 60601-2-17-1996+A1-1996 | 醫(yī)療電氣設(shè)備 第2-17部分:遙控自動(dòng)驅(qū)動(dòng)式γ射線(xiàn)后裝設(shè)備安全專(zhuān)用要求 | Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment (IEC 60601-2-17:1989) |
| EN 60601-2-18-1996+A1-2000 | 醫(yī)療電氣設(shè)備 第2－18部分：內(nèi)窺鏡設(shè)備安全專(zhuān)用要求 | Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996) |
| EN 60601-2-19-1996+A1-1996 | 醫(yī)療電氣設(shè)備 第2－19部分：嬰兒培養(yǎng)箱安全專(zhuān)用要求 | Medical electrical equipment - Part 2: Particular requirements for the safety of baby incubators (IEC 60601-2-19:1990) |
| EN 60601-2-2-2000 | 醫(yī)療電氣設(shè)備 第2－2部分： 高頻手術(shù)設(shè)備安全專(zhuān)用要求 | Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:1998) |
| EN 60601-2-20-1996 | 醫(yī)療電氣設(shè)備 第2－20部分：運(yùn)輸培養(yǎng)箱安全專(zhuān)用要求 | Medical electrical equipment - Part 2-20: Particular requirements for safety of transport incubators (IEC 60601-2-20:1990 + A1:1996) |
| EN 60601-2-21-1994+A1-1996 | 醫(yī)療電氣設(shè)備 第2－21部分：嬰兒輻射保暖箱安全專(zhuān)用要求 | Medical electrical equipment - Part 2: Particular requirements for the safety of infant radiant warmers (IEC 60601-2-21:1994) |
| EN 60601-2-22-1996 | 醫(yī)療電氣設(shè)備 第2－22部分：診斷和治療用激光設(shè)備安全的特殊要求 | Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995) |
| EN 60601-2-23-2000 | 醫(yī)療電氣設(shè)備 第2－23部分：經(jīng)皮分壓監(jiān)測(cè)設(shè)備的安全專(zhuān)用要求 | Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:1999) |
| EN 60601-2-24-1998 | 醫(yī)療電氣設(shè)備 第2－24部分：輸液泵和控制器的特殊安全要求 | Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998) |
| EN 60601-2-25-1995+A1-1999 | 醫(yī)療電氣設(shè)備 第2－25部分：心電圖機(jī)安全專(zhuān)用要求 | Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993) |
| EN 60601-2-28-1993 | 醫(yī)用電氣設(shè)備 第2－28部分：醫(yī)療診斷用X射線(xiàn)源組件和X射線(xiàn)管組件規(guī)范 | Medical electrical equipment; part 2-28: particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:1993) |
| EN 60601-2-29-1999 | 醫(yī)療電氣設(shè)備 第2－29部分：放射療法模擬器安全的特殊要求 | Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators (IEC 60601-2-29:1999) |
| EN 60601-2-3-1993+A1-1998 | 醫(yī)療電氣設(shè)備 第2－3部分：短波治療設(shè)備安全專(zhuān)用要求 | Medical electrical equipment; part 2: particular requirements for the safety of short-wave therapy equipment (IEC 60601-2-3:1991) |
| EN 60601-2-30-2000 | 醫(yī)療電器設(shè)備 第2-30部分：自動(dòng)循環(huán)間接血壓監(jiān)視設(shè)備和特殊安全要求 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30:1999) |
| EN 60601-2-31-1995+A1-1998 | 醫(yī)療電器設(shè)備 第2－31部分：具有內(nèi)部能源的體外心臟起搏器安全專(zhuān)用要求 | Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source (IEC 60601-2-31:1994) |
| EN 60601-2-33-2002 | 醫(yī)療電氣設(shè)備 第2－33：部分：醫(yī)療診斷用磁共振設(shè)備安全專(zhuān)用規(guī)范 | Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002) / Note: Endorsement notice |
| EN 60601-2-34-2000 | 醫(yī)療電器設(shè)備 第2－34部分：直接血壓監(jiān)視設(shè)備安全特殊要求. | Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment (IEC 60601-2-34:2000) |
| EN 60601-2-36-1997 | 醫(yī)療電氣設(shè)備 第2－36部分：體外碎石機(jī)的安全特殊要求 | Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997) |
| EN 60601-2-37-2001 | 醫(yī)療電氣設(shè)備 第2－37部分：超聲醫(yī)療診斷和監(jiān)護(hù)設(shè)備安全的特殊要求 | Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2001) |
| EN 60601-2-38-1996+A1-2000 | 醫(yī)療電器設(shè)備 第2－38部分：醫(yī)院電動(dòng)床的安全特殊要求 | Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds (IEC 60601-2-38:1996) |
| EN 60601-2-39-1999 | 醫(yī)療電氣設(shè)備 第2－39部分：腹膜透析設(shè)備安全專(zhuān)用要求 | Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment (IEC 60601-2-39:1999) |
| EN 60601-2-4-2003 | 醫(yī)療電氣設(shè)備 第2-4部分：心臟除纖維顫動(dòng)器安全性的特殊要求 | Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002) / Note: Endorsement notice |
| EN 60601-2-40-1998 | 醫(yī)療電氣設(shè)備 第2－40部分：電子機(jī)動(dòng)描記器及誘發(fā)反映設(shè)備安全專(zhuān)用要求 | Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromygraphs and evoked response equipment (IEC 60601-2-40:1998) |
| EN 60601-2-41-2000 | 醫(yī)療電氣設(shè)備 第2－41部分：外科手術(shù)燈和診斷用燈光的安全專(zhuān)用要求 | Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2000) |
| EN 60601-2-43-2000 | 醫(yī)療電氣設(shè)備 第2－43部分：介入過(guò)程用Ｘ射線(xiàn)設(shè)備安全專(zhuān)用要求 | Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures (IEC 60601-2-43:2000) |
| EN 60601-2-5-2000 | 醫(yī)療電氣設(shè)備 第2－5部分：超聲治療設(shè)備安全專(zhuān)用要求 | Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000) |
| EN 60601-2-7-1998 | 醫(yī)療電氣設(shè)備 第2－7部分：診斷X射線(xiàn)發(fā)生裝置的高壓發(fā)生器安全專(zhuān)用要求 | Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators (IEC 60601-2-7:1998) |
| EN 60601-2-8-1997+A1-1997 | 醫(yī)療電氣設(shè)備 第2－8部分：在10 kV至1 MV治療X射線(xiàn)發(fā)生裝置安全專(zhuān)用要求 | Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:1987) |
| EN 60601-3-1-1996 | 醫(yī)療電氣設(shè)備 第3－1部分：經(jīng)皮氧分壓和二氧化碳分壓監(jiān)護(hù)基本性能要求 | Medical electrical equipment - Part 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment (IEC 60601-3-1:1996) |
| EN 61010-2-041-1996 | 測(cè)量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求 第２－４１部分：醫(yī)療材料處理及實(shí)驗(yàn)室加工用蒸壓器的的特殊要求 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes (IEC 61010-2-041:1996) |
| EN 61010-2-045-2000 | 測(cè)量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求 第2－045部分：醫(yī)療、制藥、獸醫(yī)和試驗(yàn)室用洗滌器消毒的特殊要求 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields (IEC 61010-2-045:2000) |
| EN 61010-2-101-2002 | 測(cè)量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求 第2-101部分：生物體外診斷(IVD)醫(yī)療設(shè)備的特殊要求 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2002, modified) |
| EN 61157-1994 | 對(duì)醫(yī)療超聲波診斷設(shè)備聲輸出的要求 | Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:1992) |
| EN 61220-1995 | 超聲學(xué)聲場(chǎng) 0.5MHz至15MHz頻率范圍內(nèi)用水聽(tīng)器測(cè)量和表征醫(yī)療超聲設(shè)備產(chǎn)生的超聲場(chǎng)的指南 | Ultrasonics - Fields - Guidance for the measurement and characterization of ultrasonic fields generated by medical ultrasonic equipment using hydrophones in the frequency range 0,5 MHz to 15 MHz (IEC 61220:1993) |
| EN 61262-1-1994 | 醫(yī)療電氣設(shè)備 光電X-射線(xiàn)影像增強(qiáng)器特性 第1部分：入射野的測(cè)定 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 1: Determination of the entrance field size (IEC 61262-1:1994) |
| EN 61262-2-1994 | 醫(yī)療電氣設(shè)備 光電X-射線(xiàn)影像增強(qiáng)器特性 第2部分：換算因子的測(cè)定 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 2: Determination of the conversion factor (IEC 61262-2:1994) |
| EN 61262-3-1994 | 醫(yī)療電氣設(shè)備 光電X-射線(xiàn)影像增強(qiáng)器特性 第3部分：亮度分布及非均勻性測(cè)定 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 3: Determination of the luminance distribution and luminance non-uniformity (IEC 61262-3:1994) |
| EN 61262-4-1994 | 醫(yī)療電氣設(shè)備 光電X-射線(xiàn)影像增強(qiáng)器特性 第4部分：影像畸變的測(cè)定 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 4: Determination of the image distortion (IEC 61262-4:1994) |
| EN 61262-5-1994 | 醫(yī)療電氣設(shè)備 光電X-射線(xiàn)影像增強(qiáng)器特性 第5部分：次量子系統(tǒng)的測(cè)定 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 5: Determination of the detective quantum efficiency (IEC 61262-5:1994) |
| EN 61262-6-1994 | 醫(yī)療電氣設(shè)備 光電X-射線(xiàn)影像增強(qiáng)器特性 第6部分：對(duì)比度及偽影系數(shù)的測(cè)定 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 6: Determination of the contrast ratio and veiling glare index (IEC 61262-6:1994) |
| EN 61262-7-1995 | 醫(yī)療電氣設(shè)備 光電X-射線(xiàn)影像增強(qiáng)器特性 第7部分：調(diào)制傳遞函數(shù)的測(cè)定 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function (IEC 61262-7:1995) |
| EN 61303-1995 | 醫(yī)療電氣設(shè)備 放射性核素準(zhǔn)直器 描述性能的特殊方法 | Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance (IEC 61303:1994) |
| EN 61558-2-15-2001 | 電力變壓器、電源裝置及類(lèi)似設(shè)備的安全 第2-15部分：醫(yī)療場(chǎng)所供電用隔離變壓器的特殊要求 | Safety of power transformers, power supply units and similar - Part 2-15: Particular requirements for isolating transformers for the supply of medical locations (IEC 61558-2-15:1999, modified) |
| EN 61676-2002 | 醫(yī)療電氣設(shè)備 用于診斷放射線(xiàn)學(xué)中X射線(xiàn)管電壓非發(fā)病測(cè)量的劑量測(cè)定儀 | Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002) / Note: Endorsement notice |
| EN 724-1994 | 無(wú)源醫(yī)療器械用EN29001、EN46001、EN29002、EN46002標(biāo)準(zhǔn)的應(yīng)用指南 | Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices |
| EN 737-1-1998 | 醫(yī)療氣體管道系統(tǒng) 第1部分：壓縮醫(yī)療氣體和真空用終端設(shè)備 | Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum |
| EN 737-2-1998+A1-1999+AC-2000 | 醫(yī)療氣體管道系統(tǒng) 第2部分：麻醉氣體凈化處理系統(tǒng) 基本要求 | Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements |
| EN 737-3-1998+A1-1999+AC-2000 | 醫(yī)療氣體管道系統(tǒng) 第3部分：壓縮醫(yī)療氣體和真空用管道 | Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum |
| EN 737-4-1998 | 醫(yī)療氣體管道系統(tǒng) 第4部分：麻醉氣體凈化系統(tǒng)的終端設(shè)備 | Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems |
| EN 738-4-1998+A1-2002 | 醫(yī)用氣體用壓力調(diào)節(jié)器 第4部分：醫(yī)療設(shè)備用低壓壓力調(diào)節(jié)器 | Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment |
| EN 739-1998+A1-2002 | 醫(yī)療氣體設(shè)備用低壓軟管組件 | Low-pressure hose assemblies for use with medical gases |
| EN 793-1997 | 醫(yī)療供應(yīng)設(shè)備安全的特殊要求 | Particular requirements for safety of medical supply units |
| EN 868-1-1997 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第1部分：一般要求和試驗(yàn)方法 | Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods |
| EN 868-10-2000 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第10部分：生產(chǎn)熱密封袋、卷軸和蓋的聚烯烴粘性涂層非編織材料 要求和 | Packaging materials and systems for medical devices which are to be sterilized - Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods |
| EN 868-2-1999 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第2部分：消毒包裹物 要求和試驗(yàn)方法 | Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and test methods |
| EN 868-3-1999 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第3部分：生產(chǎn)紙袋（EN 868-4規(guī)定）和生產(chǎn)盒和卷筒用紙（EN 868-5規(guī)定 | Packaging materials and systems for medical devices which are to be sterilized - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods |
| EN 868-4-1999 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第4部分：紙袋 要求和試驗(yàn)方法 | Packaging materials and systems for medical devices which are to be sterilized - Part 4: Paper bags - Requirements and test methods |
| EN 868-5-1999+AC-2001 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第5部分：紙、塑料薄膜結(jié)構(gòu)的熱和可自密封袋及卷軸 要求和試驗(yàn)方法 | Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods |
| EN 868-6-1999 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第6部分：生產(chǎn)經(jīng)氧化乙烯或輻照消毒的醫(yī)用包所用的紙 要求和試驗(yàn)方法 | Packaging materials and systems for medical devices which are to be sterilized - Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods |
| EN 868-7-1999 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第7部分：生產(chǎn)經(jīng)氧化乙烯或輻射消毒的醫(yī)用熱密封包所用的粘性涂覆紙 | Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods |
| EN 868-8-1999 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第8部分：符合EN 285的蒸汽消毒器用可重復(fù)使用的消毒容器 要求和試驗(yàn) | Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods |
| EN 868-9-2000 | 經(jīng)消毒的醫(yī)療器械用包裝材料和系統(tǒng) 第9部分：生產(chǎn)熱密封袋、卷軸和蓋的聚烯烴非涂層非編織材料 要求和試 | Packaging materials and systems for medical devices which are to be sterilized - Part 9: Uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods |
| EN 928-1995 | 玻璃試管診斷系統(tǒng) 關(guān)于玻璃試管診斷醫(yī)療設(shè)備的EN 29001、EN 46001、EN 29002、EN 46002的應(yīng)用指南 | In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices |
| EN 980-2003 | 醫(yī)療器械標(biāo)簽用圖形符號(hào) | Graphical symbols for use in the labelling of medical devices |
| EN ISO 10079-1-1999 | 醫(yī)療吸引設(shè)備 第1部分：電動(dòng)吸引設(shè)備 安全要求 | Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999) |
| EN ISO 10079-2-1999 | 醫(yī)療吸引設(shè)備 第2部分：手動(dòng)吸引設(shè)備 | Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999) |
| EN ISO 10079-3-1999 | 醫(yī)療吸引設(shè)備 第3部分：真空或用壓力驅(qū)動(dòng)吸引設(shè)備 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) |
| EN ISO 10993-1-2003 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第1部分：評(píng)價(jià)與試驗(yàn) | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003) |
| EN ISO 10993-10-2002 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第10部分：刺激與致敏試驗(yàn) | Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) |
| EN ISO 10993-11-1995 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第11部分：全身毒性試驗(yàn) | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:1993) |
| EN ISO 10993-12-1996 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第12部分：樣品制備和參照物 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:1996) |
| EN ISO 10993-13-1998 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第13部分：聚合物醫(yī)療器械降解產(chǎn)物的定性與定量 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) |
| EN ISO 10993-14-2001 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第14部分：陶瓷降解產(chǎn)物的識(shí)別與合格鑒定 | Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
| EN ISO 10993-15-2000 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第15部分：金屬與合金降解產(chǎn)物的識(shí)別與定性 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
| EN ISO 10993-16-1997 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第16部分：降解產(chǎn)物與可容出物的毒物動(dòng)力學(xué)研究設(shè)計(jì) | Biological evaluation of medical devices - Part 16: Toxickinetic study design for degradation products and leachables (ISO 10993-16:1997) |
| EN ISO 10993-17-2002 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第17部分：可濾物質(zhì)允許權(quán)限的評(píng)定 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| EN ISO 10993-2-1998 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第2部分：動(dòng)物保護(hù)要求 | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:1992) |
| EN ISO 10993-4-2002 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第4部分:與血液相互作用的試驗(yàn)選擇 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002) |
| EN ISO 10993-5-1999 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第5部分：體外細(xì)胞毒性試驗(yàn) | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) |
| EN ISO 10993-7-1995 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第7部分：環(huán)氧乙烷滅菌殘留量 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995) |
| EN ISO 10993-8-2000 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第8部分：生物學(xué)試驗(yàn)參照樣品的選擇和定性 | Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests (ISO 10993-8:2000) |
| EN ISO 10993-9-1999 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第9部分：潛在降解產(chǎn)物的定性與定量總則 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) |
| EN ISO 11737-2-2000 | 醫(yī)療器械滅菌 微生物學(xué)方法 第2部分：確認(rèn)滅菌過(guò)程中進(jìn)行的無(wú)菌試驗(yàn) | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998) |
| EN ISO 13485-2003 | 醫(yī)療器械 質(zhì)量管理體系 管理用途的要求 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) |
| EN ISO 14155-1-2003 | 人用醫(yī)療器械的臨床調(diào)查 第1部分：一般要求 | Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) |
| EN ISO 14155-2-2003 | 人體臨床檢查用醫(yī)療裝置 第2部分：臨床檢查計(jì)劃 | Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) |
| EN ISO 14160-1998 | 使用液體化學(xué)滅菌劑對(duì)包括動(dòng)物源材料在內(nèi)的一次性使用醫(yī)療器具進(jìn)行滅菌的確認(rèn)和常規(guī)控制 | Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid sterilants (ISO 14160:1998) |
| EN ISO 14161-2000 | 醫(yī)療保健產(chǎn)品滅菌 生物指示物 選擇、使用和檢驗(yàn)結(jié)果解釋指南 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2000) |
| EN ISO 14937-2000 | 醫(yī)療保健產(chǎn)品滅菌 消毒劑的特性及醫(yī)療裝置消毒的開(kāi)發(fā)、確認(rèn)和程序控制的一般要求 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) |
| EN ISO 14971-2000+A1-2003 | 醫(yī)療器械 對(duì)醫(yī)療器械風(fēng)險(xiǎn)管理的應(yīng)用 | Medical devices - Application of risk management to medical devices (ISO 14971:2000) |
| EN ISO 15225-2000 | 命名 用于管理資料交流的醫(yī)療器械命名系統(tǒng)規(guī)范 | Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000) |
| EN ISO 15225/prA1-2002 | 命名 用于管理資料交流的醫(yī)療器械命名系統(tǒng)規(guī)范 修改1 | Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange; Amendment 1 (ISO 15225:2000/DAM 1:2002) |
| EN ISO 17511-2003 | 體外診斷醫(yī)療裝置 生物樣品的定量測(cè)量 已知校正器及控制材料值的計(jì)量跟蹤性 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
| EN ISO 18153-2003 | 體外診斷醫(yī)療裝置 生物樣品的定量測(cè)量 用已知校準(zhǔn)器和控制材料確定酶中催化劑濃度值的計(jì)量可跟蹤性 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003) |
| EN ISO 7405-1997 | 牙科學(xué) 用于牙科的醫(yī)療器械生物相容性臨床前評(píng)價(jià) 牙科材料的試驗(yàn)方法 | Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials (ISO 7405:1997) |
| EN ISO 9626-1995+A1-2002 | 供制造醫(yī)療器械用的不銹剛針管 | Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991) |
| ENV 1064-1993 | 醫(yī)療信息學(xué) 標(biāo)準(zhǔn)通訊協(xié)議 計(jì)算機(jī)輔助心電圖學(xué) | Medical informatics - Standard communication protocol - Computer-assisted electrocardiography |
| ENV 1068-1993 | 醫(yī)療信息學(xué) 保健信息交換 代碼方案注冊(cè) | Medical informatics - Healthcare information interchange - Registration of coding schemes |
| ENV 12017-1997 | 醫(yī)療信息學(xué) 醫(yī)療信息學(xué)詞匯( MIVoc ) | Medical Informatics - Medical Informatics Vocabulary (MIVoc) |
| ENV 12052-1997 | 醫(yī)療信息學(xué) 醫(yī)療成像傳送（MEDICOM） | Medical informatics - Medical Imaging Communication (MEDICOM) |
| ENV 12264-1997 | 醫(yī)療信息學(xué) 概念系統(tǒng)完備結(jié)構(gòu) 警告表述模型 | Medical informatics - Categorical structures of systems of concepts - Model for representation of sematics |
| ENV 12388-1996 | 醫(yī)療信息學(xué) 保健中數(shù)字簽字服務(wù)算法 | Medical informatics - Algorithm for Digital Signature Services in Health Care |
| ENV 12435-1999 | 醫(yī)療信息學(xué) 健康學(xué)中測(cè)量結(jié)果的表述 | Medical Informatics - Expression of the results of measurements in health sciences |
| ENV 12443-1999 | 醫(yī)療信息學(xué) 保健信息框架(HIF) | Medical informatics - Healthcare Information Framework (HIF) |
| ENV 12611-1997 | 醫(yī)學(xué)信息學(xué) 概念體系的范疇結(jié)構(gòu) 醫(yī)療器械 | Medical informatics - Categorial structure of systems of concepts - Medical devices |
| ENV 12623-1997 | 醫(yī)學(xué)信息學(xué) 在醫(yī)療圖象傳送中的媒介質(zhì)交換（MI-MEDICOM） | Medical Informatics - Media Interchange in Medical Imaging Communications (MI-MEDICOM) |
| ENV 12967-1-1998 | 醫(yī)療信息學(xué) 保健信息系統(tǒng)結(jié)構(gòu)（HISA） 第1部分：保健中間層 | Medical informatics - Healthcare Information System Architecture (HISA) - Part 1: Healthcare middleware layer |
| ENV 13004-1999 | 用于管理數(shù)據(jù)交換的醫(yī)療設(shè)備命名系統(tǒng) 關(guān)于臨時(shí)系統(tǒng)的建議和未來(lái)系統(tǒng)的原則 | Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system |
| ENV 13607-2000 | 健康信息學(xué) 醫(yī)療處方信息交換信息 | Health informatics - Messages for the exchange of information on medicine prescription |
| ENV 13735-2000 | 健康信息學(xué) 與患者相關(guān)的醫(yī)療器械的互操作性 | Health informatics - Interoperability of patient connected medical devices |
| ENV 13939-2001 | 健康信息 醫(yī)療數(shù)據(jù)交換 HIS/RIS-PACK和HIS/RIS 程式接口 | Health informatics - Medical Data Interchange: HIS/RIS-PACS and HIS/RIS - Modality Interface |
| ENV 737-6-2003 | 醫(yī)療氣體管道系統(tǒng) 第6部分：壓縮醫(yī)療氣體和真空用終端部件用探針的尺寸 | Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum |
| HD 364 S2-1983 | 醫(yī)療X光設(shè)備用高壓電纜插頭和插座連接 | High-voltage cable plug and socket connections for medical X-ray equipment |
| HD 513 S1-1989 | 醫(yī)療診斷用最大旋轉(zhuǎn)陽(yáng)極X射線(xiàn)管對(duì)稱(chēng)輻射場(chǎng)的測(cè)定 | Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis |
| IEEE 1073-1996 | 醫(yī)療設(shè)備通訊的總論和框架 | (Medical device communications - Overview and framework) |
| IEEE 1073.3.1a-2000 | 醫(yī)療通信裝置.傳送輪廓.連接模式.修改件1:改正和分類(lèi) | (Medical device communications - Transport profile - Connection mode; Amendment 1: Corrections and clarifications) |
| IEEE 1073.3.2-2000 | 醫(yī)療裝置通信.傳輸層.連接IrDA基電纜 | (Medical device communications - Transport profile - IrDA based cable connected) |
| IEEE 1073.4.1-2000 | 醫(yī)療裝置通信.物理層接口.電纜連結(jié) | (Medical device communications - Physical layer interface - Cable connected) |
| prEN 13159-1999 | 帶氧氣的醫(yī)療設(shè)備的兼容性 | Compatibility of medical equipment with oxygen |
| prEN 13824-2002 | 醫(yī)療器械的消毒 無(wú)菌加工的驗(yàn)證和常規(guī)控制 要求和指南 | Sterilization of medical devices - Validation and routine control of aseptic processes - Requirements and guidance |
| prEN 14254-2001 | 體外診斷醫(yī)療設(shè)備 除血液外從人體采集的樣品一次性貯存容器 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| prEN 14476-2002 | 化學(xué)防腐劑和消毒劑 人類(lèi)醫(yī)療用化學(xué)防腐劑和消毒劑的殺病毒定量懸浮試驗(yàn) 試驗(yàn)方法和要求（2相/1段） | Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2/step 1) |
| prEN 389-1990 | 非活性醫(yī)療器械的標(biāo)簽 | Labelling of non-active medical devices |
| prEN 45502-2-1-2003 | 活動(dòng)可植入的醫(yī)療器件 第2-1部分：對(duì)治療心動(dòng)過(guò)緩的活動(dòng)可植入醫(yī)療器件(心臟起搏器)的特殊要求. | Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrythmia (cardiac pacemakers) |
| prEN 45502-2-2-1998 | 活動(dòng)可科植入醫(yī)療器件 第2-2部分：用于治療心動(dòng)過(guò)速的活性可植入醫(yī)療器件的特殊要求（包括植入除纖顫器） | Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrythmia (includes implantable defibrillators) |
| prEN 50339-2000 | 醫(yī)療設(shè)備 X射線(xiàn)膠片 | Medical devices - X-ray film |
| prEN 55011-2003 | 工業(yè)、科學(xué)、醫(yī)療（ISM）射頻設(shè)備 電磁騷擾特性 測(cè)量方法和限值 | CISPR 11, Ed. 4.0: Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement |
| prEN 556-2-2003 | 醫(yī)療器械的消毒 標(biāo)明為“消過(guò)毒”的醫(yī)療器械的要求 第2部分：消毒處理的醫(yī)療器械的要求 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices |
| prEN 60601-1-8-2003 | 醫(yī)院電氣設(shè)備 第1部分：安全通用要求 第8節(jié)：并列標(biāo)準(zhǔn) 報(bào)警系統(tǒng) 要求 試驗(yàn)和指南 醫(yī)療電子和電氣 | Medical electrical equipment - Part 1-8: General requirements for safety; Collateral standard: Alarm systems; General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| prEN 61010-2-041-1996 | 測(cè)量、控制和實(shí)驗(yàn)室用電氣設(shè)備的安全要求 第2－41部分：醫(yī)療材料處理及實(shí)驗(yàn)室加工用蒸壓器的的特殊要求 | Draft IEC 1010-2-041: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes |
| prEN 61681-1-2000 | 超聲學(xué) 場(chǎng)安全 第1部分： 醫(yī)療診斷超聲波場(chǎng)分類(lèi)表 | IEC 61681-1: Ultrasonics - Field safety - Part 1: Classification scheme for medical diagnostic ultrasonic fields |
| prEN 61814-1997 | 人體接觸電極器具 沒(méi)有醫(yī)療監(jiān)督條件下使用的安全要求 | IEC 61814: Appliances with human body contact electrodes - Safety requirements for use without medical supervision |
| prEN 61948-1-1998 | 核醫(yī)療儀 特性和試驗(yàn)條件 第1部分：輻射計(jì)數(shù)系統(tǒng) | IEC 61948-1: Nuclear medicine instrumentation - Characteristics and test conditions - Part 1: Radiation counting systems |
| prEN 61948-2-1998 | 核醫(yī)療儀 特性和試驗(yàn)條件 第2部分：閃光照相機(jī)和旋轉(zhuǎn)X線(xiàn)體層照相機(jī) | IEC 61948-2: Nuclear medicine instrumentation - Characteristics and test conditions - Part 2: Scintillation cameras and rotational tomographs |
| prEN 61973-2000 | 超聲學(xué) 場(chǎng)特性 測(cè)定醫(yī)療診斷超聲場(chǎng)安全分類(lèi)曝光參數(shù)的試驗(yàn)方法 | IEC 61973: Ultrasonics - Field characterisation - Test methods for the determination of exposure parameters for the safety classification of medical diagnostic ultrasonic fields |
| prEN ISO 10993-3-2003 | 醫(yī)療器械的生物學(xué)評(píng)價(jià) 第3部分：遺傳毒性、致癌性和生殖毒性試驗(yàn) | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/FDIS 10993-3:2003) / Note: Intended as replacement for EN 30993-3 (1993-12). |
| prEN ISO 17664-2003 | 醫(yī)療裝置的消毒 由制造商提供的可消毒裝置回收利用信息 | Sterilization of medical devices - Information to be provided by the manufacturer for the reprocessing of resterilizable devices (ISO/FDIS 17664:2003) |
| prENV 12265-1995 | 醫(yī)療信息學(xué) 電子保健記錄體系結(jié)構(gòu) | Medical informatics - Electronic healthcare record architecture |
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