JAB NF01 REV JIS Q 17025: /
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1 JAB RL /
2 JAB NF01 REV JIS Q 17025: /
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5 JAB (JIS Q 17025, ISO/IEC 17025) JIS Q JAB 1.1 JIS Q IEC JAB JIS Q JIS Q JIS Q JIS Q JAB 1.2 JAB RL JAB RL IEC IEC /
6 x, IEC x IEC xIEC IEC ( ) 2.1 a)jab RL200 ( ) b)jab RL205 c)jab RL331 d)jab RL352 e)jab NL410 f)jis Q g)iso/iec General requirements for the competence of calibration and testing laboratories h)iso 9000 Quality management systems - Fundamentals and vocabulary i)iso/iec Conformity assessment-vocabulary and general principle j)vim (International vocabulary of basic and general terms in metrology, issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML) k)iso/iec Guide Expres GUM; Guide to the Expression of Uncertainty in Measurement:1995, issued by BIPM, IEC, ISO, IFCC, IUPAC, IUPAP and OIML () l)ilac P10 ILAC Policy on Traceability of Measurement Results m)aplac MR-001 Procedures for establishing and maintaining mutual recognition arrangements amongst accreditation bodies n)aplac PT002 APLAC Testing Interlaboratory Comparisons o) p)iec Medical electrical equipment Part 1: General requirements for basic safety and essential performance 2.2 a)iso/iec Guide 43-1 Proficiency testing by interlaboratory comparisons - Part 1: Development and operation of proficiency testing schemes /
7 b)iso/iec Guide 43-2Proficiency testing by interlaboratory comparisons - Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies c)iso Medical devices - Quality management systems - System requirements for regulatory purposes d)iso Medical devices - Application of risk management to medical devices e)iec Dependability management - Part3: Application guide - Section 9: Risk analysis of technological systems f)jis T 14971: g)nist Handbook 150 Procedures and General Requirements h)nata ISO/IEC Application Document - Supplementary Requirements for Accreditation in the Field of Electrical Testing, National Association of Testing Authorities, Australia i)interpretation of ISO/IEC and its Application Guide (Authored by the Society for the Study of 17025, Issued by Maruzen) j)jab Web-site (Criteria and Guidance Documents on Laboratory Accreditation Program) (medical electrical equipment) a) / b) / c), (IEC ) ( ) (safety testing for medical electrical equipment (IEC ) 3.3 EUTequipment under test 3.4 (approved signatory) JAB /
8 3.5 (reference standards) 3.6 (calibration) VIM 3.7 verification (ISO 9000 ) 3.8 validation 3.9 uncertainty of measurement VIM 3.10 (interlaboratory comparisons testing) ISO/IEC Guide proficiency testing ISO/IEC Guide repeatability VIM 3.13 reproducibility VIM a) /
9 1) 2) b) JAB NL410 ( ) /
10 JIS Q a) ( ) b) c) d) e) f) ( ) g) h) i) /
11 ISO 13485, JIS T a) b) c) d) e) f) /
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13 a) b) JIS Q JIS Q ma A /
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16 a) APLAC MR 001 Procedures for establishing and maintaining mutual recognition arrangements amongst accreditation bodies 3.3 Proficiency testing activity 4 APLAC PT002 APLAC Testing Interlaboratory Comparisons ( ) APLAC APLAC z 3 z x X z= s s ( ) x X ( ) b) /
17 a) b) 95 (coverage factor) c) JAB NL410 ( ) /
18 a) b) a) b) c) /
19 a) b) ( ) CIPM (1) ILAC (2) 1:CIPM Comité International des Poids et Measures ( 2:ILAC International Laboratory Accreditation Cooperation ( /
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22 ( ) JIS JIS C5512 JIS T JIS T JIS T JIS T X JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T JIS T /
23 JIS T JIS T JIS T1031 JIS T1115 JIS T1117 JIS T1140 JIS T1190 JIS T JIS T JIS T1202 JIS T1204 JIS T1205 JIS T1206 JIS T1303 JIS T1653 JIS T1701 JIS T1702 JIS T4203 JIS T5109 JIS T5602 JIS T5701 JIS T JIS T JIS T JIS T7203 JIS T7204 JIS T7205 JIS T7206 JIS T7303 JIS T7307 JIS T7309 JIS T7311 JIS T7312 JIS T7317 JIS T7318 JIS T7319 JIS T7321 JIS T7327 JIS T14971 JIS JIS Z4620 JIS Z4701 JIS Z4702 JIS Z4703 JIS Z4704 X X X X /
24 JIS Z4705 JIS Z4711 JIS Z4712 JIS Z4714 JIS Z4721 JIS Z JIS Z JIS Z JIS Z JIS Z4831 JIS Z4904 JIS Z4910 JIS Z4951 X X X IVR X /
25 ( ) CISPR 11 Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement CISPR 23 Determination of limits for industrial, scientific and medical equipment CISPR/TR3 28 Industrial, scientific and medical equipment (ISM) - Guidelines for emission levels within the bands designated by the ITU IEC Electrical apparatus for explosive gas atmospheres - Part 14: Electrical installations in hazardous areas (other than mines) IEC Household and similar electrical appliances - Safety - Part 2-90: Particular requirements for commercial microwave ovens IEC X-ray tube assemblies for medical diagnosis - Characteristics of focal spots IEC Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations IEC Electrical installations of buildings - Part 7-717: Requirements for special installations or locations - Mobile or transportable units IEC/TR ) Fundamental aspects of safety standards for medical electrical equipment IEC Determination of the permanent filtration of X-ray tube assemblies IEC High-voltage cable plug and socket connections for medical X-ray equipment IEC Medical electrical equipment - Dose area product meters IEC Luminaires - Part 2: Particular requirements - Section 25: Luminaires for use in clinical areas of hospitals and health care buildings IEC Corrigendum 1 - Luminaires - Part 2: Particular requirements - Section 25: Luminaires for use in clinical areas of hospitals and health care buildings IEC Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ) IEC Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems /
26 IEC Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC Medical electrical equipment - Part 1: General requirements for safety - 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment IEC Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems IEC Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC SER Medical electrical equipment - ALL PARTS IEC Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV IEC Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment IEC Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment IEC Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators IEC Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment IEC Medical electrical equipment. Part 2: Particular requirements for the safety of microwave therapy equipment IEC Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators IEC Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kv to 1 MV IEC Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors IEC Medical electrical equipment. Part 2: Particular requirements for the safety of nerve and muscle stimulators IEC Medical electrical equipment - Part 2: Particular requirements for the safety of gamma beam therapy equipment /
27 IEC Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators IEC Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems IEC Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment IEC Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment IEC Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment IEC Medical electrical equipment. Part 2: Particular requirements for the safety of baby incubators IEC Medical electrical equipment. Part 2: Particular requirements for the safety of transport incubators IEC Medical electrical equipment - Part 2: Particular requirements for the safety of infant radiant warmers IEC Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment IEC Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment IEC Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers IEC Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs IEC Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs IEC Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment IEC Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis IEC Medical electrical equipment - Part 2-29: Particular requirements for the safety of radiotherapy simulators /
28 IEC Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source IEC Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment IEC Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis IEC Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment IEC Medical electrical equipment - Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use IEC Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy IEC Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment IEC Medical electrical equipment - Part 2: Particular requirements for the safety of electrically operated hospital beds IEC Medical electrical equipment - Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment IEC Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment IEC Medical electrical equipment - Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis IEC Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures IEC Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography IEC Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices IEC Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables IEC Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems /
29 IEC Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment IEC Medical electrical equipment - Part 2-50: Particular requirements for the safety of infant phototherapy equipment IEC Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs IEC Medical electrical equipment - Part 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment IEC Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis IEC Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy IEC Hand-held motor-operated electric tools - Safety - Part 1: General requirements IEC/TR Medical electrical equipment - Glossary of defined terms IEC Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis IEC/TR Safety of laser products - Part 8: Guidelines for the safe use of medical laser equipment IEC Safety of laser products - Part 12: Safety of free space optical communication systems used for transmission of information IEC/TR Methods of measuring the performance of ultrasonic pulse-echo diagnostic equipment IEC Characteristics and calibration of hydrophones for operation in the frequency range 0.5 MHz to 15 MHz IEC/TR Graphical symbols for electrical equipment in medical practice IEC/TR Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment IEC Medical electrical equipment - Medical electron accelerators - Functional performance characteristics IEC/TR Medical electrical equipment - Medical electron accelerators in the range of 1 MeV to 50 MeV - Guidelines for functional performance characteristics IEC 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 /
30 IEC Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes IEC Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-043: Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of medical materials, and for laboratory processes IEC 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 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment IEC/TR Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-041: Conformity verification report for IEC :1995, Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes IEC/TR Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-042: Conformity verification report for IEC :1997, Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes IEC/TR Safety requirements for electrical equipment for measurement, control and laboratory use - Part 3-043: Conformity verification report for IEC : Particular requirements for dry heat sterilizers using either hot air or hot inert gas for treatment of medical materials and for laboratory processes IEC/TR Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-045: Conformity verification report for IEC : Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields IEC/TR Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-101: Conformity verification report for IEC : Particular requirements for in vitro diagnostic (IVD) medical equipment IEC Measurement and characterisation of ultrasonic fields using hydrophones in the frequency range 0.5 MHz to 15 MHz IEC Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment IEC/TR Extra-low voltage (ELV) - Limit values /
31 IEC Low-voltage power supply devices, d.c. output - Performance characteristics IEC Radiotherapy equipment - Coordinates, movements and scales IEC/TR Ultrasonics - Fields - Guidance for the measurement and characterization of ultrasonic fields generated by medical ultrasonic equipment using hydrophones in the frequency range 0,5 to 15 MHz IEC/TR Evaluation and routine testing in medical imaging departments - Part 1: General aspects IEC/TR Evaluation and routing testing in medical imaging departments - Part 2-1: Constancy tests - Film processors IEC Evaluation and routine testing in medical imaging departments - Part 2-4: Constancy tests - Hard copy cameras IEC Evaluation and routine testing in medical imaging departments - Part 2-5: Constancy tests - Image display devices IEC Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - X-ray equipment for computed tomography IEC Evaluation and routine testing in medical imaging departments - Part 2-7: Constancy tests - Equipment for intra-oral dental radiography excluding dental panoramic equipment IEC Evaluation and routine testing in medical imaging departments - Part 2-9: Constancy tests - Equipment for indirect radioscopy and indirect radiography IEC Evaluation and routine testing in medical imaging departments - Part 2-10: Constancy tests - X-ray equipment for mammography IEC Evaluation and routine testing in medical imaging departments - Part 2-11: Constancy tests - Equipment for general direct radiography IEC Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems IEC Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment IEC Evaluation and routine testing in medical imaging departments - Part 3-3: Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA) IEC Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment IEC Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment IEC/TR Guidelines for the development and use of medical electrical equipment educational materials /
32 IEC Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 1: Determination of the entrance field size IEC Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 2: Determination of the conversion factor IEC Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 3: Determination of the luminance distribution and luminance non-uniformity IEC Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 4: Determination of the image distortion IEC Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 5: Determination of the detective quantum efficiency IEC Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 6: Determination of the contrast ratio and veiling glare index IEC Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 7: Determination of the modulation transfer function IEC Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics IEC/TR Cardiac defibrillators - Cardiac defibrillator-monitors - Part 1: Operation IEC/TR High frequency surgical equipment - Part 1: Operation IEC Medical electrical equipment - Radionuclide calibrators - Particular methods for describing performance IEC Protective devices against diagnostic medical X-radiation - Part 1: Determination of attenuation properties of materials IEC Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates IEC Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads IEC/TR Ultrasonics - Real-time pulse-echo systems - Test procedures to determine performance specifications IEC Safety of power transformers, power supply units and similar - Part 2-15: Particular requirements for isolating transformers for the supply of medical locations IEC Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging IEC Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC Ultrasonics - Focusing transducers - Definitions and measurement methods for the transmitted fields IEC/TR Medical electrical equipment - Digital imaging and communications in medicine (DICOM) - Radiotherapy objects IEC/TR Guidelines for radiotherapy treatment rooms design /
33 IEC Mobile and fixed offshore units - Electrical installations - Part 1: General requirements and conditions IEC Power installations exceeding 1 kv a.c. - Part 1: Common rules IEC Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems IEC Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency IEC/TR Medical electrical equipment - Guidelines for implementation of DICOM in radiotherapy IEC/TR Considerations of unaddressed safety aspects in the Second Edition of IEC and proposals for new requirements IEC Medical device software - Software life cycle processes ISO/IEC GUIDE 63 Guide to the development and inclusion of safety aspects in International Standards for medical devicesiec/tr /
JAB NF01 REV JIS Q 17025: /
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国際規格番号 規格名称 JIS 化状況 8 IEC/TS Safety of machinery - Electro-sensitive protective equipment - Part 4-3: Particular requirements for equipment
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