List Of Recognised Standards - Japan - IMDRF

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JapanStatus: 2014-07-29PLEASE FILL IN:IF YES YFOR NO NFOR Partial PStatus NStandard, N-E Draft, VN-Epredraft,Document ReferencePublicationIEC 60118-01983NIEC 60118-0 AMD 11994-01NIEC 60118-11995-04NIEC 60118-1 AMD 11998-07NEnglish TitleMeasurement of electroacoustical characteristicsHearing aids; part 0: measurement of electroacousticalcharacteristics; amendment 1Hearing aids - Part 1: Hearing aids with induction pick-upcoil inputHearing aids - Part 1: Hearing aids with induction pick-upcoil input; Amendment 1Hearing aids - Part 1: Hearing aids with induction pick-upcoil inputHearing aids - Part 12: Dimensions of electricalconnector systemsElectroacoustics - Hearing aids - Part 13:Electromagnetic compatibility (EMC)Hearing aids - Part 14: Specification of a digital interfacedeviceElectroacoustics - Hearing aids - Part 15: Methods forcharacterising signal processing in hearing aids with aspeach-like signalHearing aids. Part 2 : Hearing aids with automatic gaincontrol circuitsHearing aids; part 2: hearing aids with automatic gaincontrol circuits; amendment 1Hearing aids - Part 2: Hearing aids with automatic gaincontrol circuits; Amendment 2Electroacoustics - Hearing aids - Part 4: Induction loopsystems for hearing aid purposes - Magnetic fieldstrengthIEC 60118-1 Edition 3.11999-01NIEC 60118-121996-09NIEC 60118-132011-04NIEC 60118-141998-02NIEC 60118-152012-02NIEC 60118-21983NIEC 60118-2 AMD 11993-02NIEC 60118-2 AMD 21997-05NIEC 60118-42006-10NIEC 60118-51983NIEC 60118-61999-06NIEC 60118-72005-10NHearing aids. Part 5 : Nipples for insert earphonesHearing aids - Part 6: Characteristics of electrical inputcircuits for hearing aidsElectroacoustics - Hearing aids - Part 7: Measurementof performance characteristics of hearing aids forproduction, supply and delivery quality assurancepurposesIEC 60118-82005-10NElectroacoustics - Hearing aids - Part 8: Methods ofmeasurement of performance characteristics of hearingaids under simulated in situ working conditionsIEC 60118-91985NHearing aids. Part 9 : Methods of measurement ofcharacteristics of hearing aids with bone vibrator outputRecognised ? Yfully, P-partial,NNOPLEASE FILL IN:IF YES YFOR NO NFOR Partial PMandatory ? Yfully, P-partial,NNOIF "Y" OR "P" PLEASEADD THENATIONAL/REGIONALREFERENCE NO.PLEASE FILL IN: PLEASE FILL IN:National ReferencePublication dateof the nationalRecognition Number, ifstandardavailablePNJIS C 5512:200027.03.2000361・362・368・753PNJIS C 5512:200027.03.2000361・362・368・753PNJIS C 5512:200027.03.2000361・362・368・753PNJIS C 5512:200027.03.2000361・362・368・753PNJIS C 5512:200027.03.2000361・362・368・753PNJIS C 5512:200027.03.2000361・362・368・753PNJIS C 5512:200027.03.2000361・362・368・753

IEC 60318-42010-01NIEC 60335-2-522005-10NIEC 60335-2-52 AMD 12008-04NIEC 60335-2-52 Edition 3.12008-07NIEC 603362005-04NIEC 60336 Corrigendum 1 2006-05NIEC 60522NIEC 605262003-121978NIEC 60526 Corrigendum 1 2010-04NIEC 605802003-09NIEC 60601-12005-12NIEC 60601-1 Corrigendum 12006-12NIEC 60601-1 Corrigendum 22007-12NElectroacoustics - Simulators of human head and ear Part 4: Occluded-ear simulator for the measurement ofearphones coupled to the ear by means of ear insertsHousehold and similar electrical appliances - Safety Part 2-52: Particular requirements for oral hygieneappliancesHousehold and similar electrical appliances - Safety Part 2-52: Particular requirements for oral hygieneappliances; Amendment 1Household and similar electrical appliances - Safety Part 2-52: Particular requirements for oral hygieneappliancesMedical electrical equipment - X-ray tubeassemblies for medical diagnosis - Characteristicsof focal spotsMedical electrical equipment - X-ray tubeassemblies for medical diagnosis - Characteristicsof focal spots; Corrigendum 1Determination of the permanent filtration of X-raytube assembliesHigh-voltage cable plug and socket connections formedical X-ray equipmentHigh-voltage cable plug and socket connections formedical X-ray equipmentMedical electrical equipment - Dose area productmetersMedical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformanceMedical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance; Corrigendum 1Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance; Corrigendum 2IEC 60601-1 Interpretation 2008-04Sheet 1NIEC 60601-1 Interpretation 2009-01Sheet 2NMedical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformanceMedical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance - Interpretation sheet 2NMedical electrical equipment - Part 1-1: Generalrequirements for safety; Collateral standard: Safetyrequirements for medical electrical systemsNMedical electrical equipment - Part 1-10: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Requirementsfor the development of physiologic closed-loopcontrollersIEC 60601-1-1IEC 60601-1-102000-122007-11PNJIS Z 4102:2005JIS Z JIS Z 4704:200525.03.20053・13・PNJIS T 0601-1:201201.06.2012See #4(279) on sheet1PNJIS T 0601-1:201201.06.2012See #4(279) on sheet1PNJIS T 0601-1:201201.06.2012See #4(279) on sheet1YNJIS T 0601-1-1:200525.03.2005See #5(136) on sheet1

IEC 60601-1-112010-04NIEC 60601-1-11 Corrigendum2011-041NNMedical electrical equipment - Part 1-11: Generalrequirements for basic safety and essentialperformance - Collateral standard: Requirementsfor medical electrical equipment and medicalelectrical systems used in the home healthcareenvironment; Technical Corrigendum 1Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard:Electromagnetic compatibility - Requirements andtestsMedical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard:Electromagnetic compatibility - Requirements andtestsNMedical electrical equipment - Part 1-3: Generalrequirements for basic safety and essential performance Collateral standard: Radiation protection in diagnostic Xray equipmentNMedical electrical equipment - Part 1: Generalrequirements for safety - 4. Collateral standard:Programmable electrical medical systemsIEC 60601-1-11 Technical Corrigendum2011-041NIEC 60601-1-2N2007-03IEC 60601-1-2 Interpretation2010-03Sheet 1IEC 60601-1-3IEC 60601-1-42008-011996-05Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essentialperformance - Collateral standard: Requirementsfor medical electrical equipment and medicalelectrical systems used in the home healthcareenvironmentMedical electrical equipment - Part 1-11: Generalrequirements for basic safety and essentialperformance - Collateral standard: Requirementsfor medical electrical equipment and medicalelectrical systems used in the home healthcareenvironmentIEC 60601-1-4 AMD 11999-10NIEC 60601-1-4 Edition 1.12000-04NIEC 60601-1-62010-01NMedical electrical equipment - Part 1-4: Generalrequirements for safety - Collateral standard:Programmable electrical medical systems;Amendment 1Medical electrical equipment - Part 1-4: Generalrequirements for safety - Collateral standard:Programmable electrical medical systemsMedical electrical equipment - Generalrequirements for basic safety and essentialperformance - Collateral Standard: UsabilityNMedical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Generalrequirements, tests and guidance for alarmsystems in medical electrical equipment andmedical electrical systemsIEC 60601-1-82006-10YYNNJIS T 0601-1-2:2012JIS T 0601-1-3:201228.03.2012See #6(275) on ��6・8・9・10・11・12・13・14・364

IEC 60601-1-92007-07NIEC 60601-2-12009-10NIEC 60601-2-101987NIEC 60601-2-10 AMD 12001-09NIEC 60601-2-10 AMD 1 Corrigendum2002-02 1NIEC 60601-2-111997-08NIEC 60601-2-11 AMD 12004-07NIEC 60601-2-132003-05NIEC 60601-2-13 AMD 12006-05NIEC 60601-2-13 Edition 3.12009-08NIEC 60601-2-162008-04NIEC 60601-2-16 Corrigendum2008-101NIEC 60601-2-172005-09NIEC 60601-2-182009-08NIEC 60601-2-192009-02NMedical electrical equipment - Part 1-9: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Requirementsfor environmentally conscious designMedical electrical equipment - Part 2-1: Particularrequirements for the basic safety and essentialperformance of electron accelerators in the range1 MeV to 50 MeVMedical electrical equipment; part 2: particularrequirements for the safety of nerve and musclestimulatorsMedical electrical equipment - Part 2-10:Particular requirements for the safety of nerve andmuscle stimulators; Amendment 1Medical electrical equipment - Part 2-10:Particular requirements for the safety of nerve andmuscle stimulators; Amendment 1Medical electrical equipment - Part 2: Particularrequirements for the safety of gamma beamtherapy equipmentAmendment 1 - Medical electrical equipment Part 2-11: Particular requirements for the safety ofgamma beam therapy equipmentMedical electrical equipment - Part 2-13:Particular requirements for the safety and essentialperformance of anaesthetic systemsMedical electrical equipment - Part 2-13:Particular requirements for the safety and essentialperformance of anaesthetic systems;Amendment 1Medical electrical equipment - Part 2-13:Particular requirements for the safety of anaestheticsystemsMedical electrical equipment - Part 2-16:Particular requirements for basic safety andessential performance of haemodialysis,haemodiafiltration and haemofiltration equipmentMedical electrical equipment - Part 2-16:Particular requirements for basic safety andessential performance of haemodialysis,haemodiafiltration and haemofiltration equipmentMedical electrical equipment - Part 2-17:Particular requirements for the safety ofautomatically-controlled brachytherapy afterloadingequipmentMedical electrical equipment - Part 2-18:Particular requirements for basic safety andessential performance of endoscopic equipmentMedical electrical equipment - Part 2-19:Particular requirements for the basic safety andessential performance of infant incubatorsPNJIS T 0601-2-10:200525.03.2005788・123・124・141PNJIS T 0601-2-10:200525.03.2005788・123・124・141PNJIS T 0601-2-10:200525.03.2005788・123・124・141PNJIS Z 4705:200525.11.2006AP7PNJIS Z 4705:200525.11.2006AP7YNJIS T ��59・60・61・62・63

IEC 60601-2-19 Corrigendum2012-021IEC 60601-2-2IEC 60601-2-202009-022009-02NMedical electrical equipment - Part 2-19:Particular requirements for the basic safety andessential performance of infant incubators;Corrigendum 1NMedical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essentialperformance of high frequency surgical equipmentand high frequency surgical accessoriesNMedical electrical equipment - Part 2-20:Particular requirements for the basic safety andessential performance of infant transport incubatorsIEC 60601-2-20 Corrigendum2012-021NIEC 60601-2-212009-02NIEC 60601-2-222007-05NMedical electrical equipment - Part 2-20:Particular requirements for the basic safety andessential performance of infant transportincubators; Corrigendum 1Medical electrical equipment - Part 2-21:Particular requirements for the basic safety andessential performance of infant radiant warmersMedical electrical equipment - Part 2-22:Particular requirements for basic safety andessential performance of surgical, cosmetic,therapeutic and diagnostic laser equipmentPNJIS T 0601-2-2:20142014/9/1150PNJIS T 0601-2-21:200525.03.2005550・119PNJIS T EC 60601-2-232011-02NIEC 60601-2-241998-02NIEC 60601-2-252011-10NIEC 60601-2-262003-12NIEC 60601-2-272011-03NMedical electrical equipment - Part 2-23:Particular requirements for the basic safety andessential performance of transcutaneous partialpressure monitoring equipmentMedical electrical equipment - Part 2-24:Particular requirements for the safety of infusionpumps and controllersMedical electrical equipment - Part 2-25:Particular requirements for basic safety andessential performance of electrocardiographsMedical electrical equipment - Part 2-26:Particular requirements for the safety ofelectroencephalographsMedical electrical equipment - Part 2-27:Particular requirements for the basic safety andessential performance of electrocardiographicmonitoring equipmentNMedical electrical equipment - Part 2-28:Particular requirements for basic safety andessential performance of X-ray tube assemblies formedical diagnosisYNNMedical electrical equipment - Part 2-29:Particular requirements for the basic safety andessential performance of radiotherapy simulatorsYNIEC 60601-2-28IEC 60601-2-292010-032008-06JIS Z 4751-2-28:20132013/9/1AP8

IEC 60601-2-31991-06NIEC 60601-2-3 AMD 11998-09NMedical electrical equipment; part 2: particularrequirements for the safety of short-wave therapyequipmentMedical electrical equipment - Part 2: Particularrequirements for the safety of short-wave therapyequipment; Amendment 1IEC 60601-2-312008-03NIEC 60601-2-31 AMD 12011-06NIEC 60601-2-31 Edition 2.12011-09NIEC 60601-2-32NMedical electrical equipment - Part 2-31:Particular requirements for basic safety andessential performance of external cardiacpacemakers with internal power sourceMedical electrical equipment - Part 2-31:Particular requirements for basic safety andessential performance of external cardiacpacemakers with internal power sourceMedical electrical equipment - Part 2-31:Particular requirements for basic safety andessential performance of external cardiacpacemakers with internal power sourceMedical electrical equipment; part 2: particularrequirements for the safety of X-ray equipmentNMedical electrical equipment - Part 2-33: Particularrequir

IEC 60526 : 1978. N : High-voltage cable plug and socket connections for medical X-ray equipment . IEC 60526 Corrigendum 1 : 2010-04. N : High-voltage cable plug and socket connections for medical X-ray equipment . IEC 60580 : 2003-09. N : Medical electrical equipment_- Dose area productFile Size: 721KBPage Count: 54