Стандарт DIN EN ISO 13485:2016-08

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01 Generalities. Terminology. Standardization. Documentation / Общие положения. Терминология. Стандартизация. Документация

03 Services. Company organization, management and quality. Administration. Transport. Sociology / Услуги. Организация фирм и управление ими. Администрация. Транспорт. Социология

07 Mathematics. Natural Sciences / Математика. Естественные науки

11 Health care technology / Здравоохранение

13 Environment. Health protection. Safety / Охрана окружающей среды, защита человека от воздействия окружающей среды. Безопасность

17 Metrology and measurement. Physical phenomena / Метрология и измерения. Физические явления

19 Testing / Испытания

21 Mechanical systems and components for general use / Механические системы и устройства общего назначения

23 Fluid systems and components for general use / Гидравлические и пневматические системы и компоненты общего назначения

25 Manufacturing engineering / Машиностроение

27 Energy and heat transfer engineering / Энергетика и теплотехника

29 Electrical engineering / Электротехника

31 Electronics / Электроника

33 Telecommunications. Audio and video engineering / Телекоммуникации. Аудио- и видеотехника

35 Information technology. Office machines / Информационные технологии. Машины конторские

37 Image technology / Технология получения изображений

39 Precision mechanics. Jewellery / Точная механика. Ювелирное дело

43 Road vehicles engineering / Дорожно-транспортная техника

45 Railway engineering / Железнодорожная техника

47 Shipbuilding and marine structures / Судостроение и морские сооружения

49 Aircraft and space vehicle engineering / Авиационная и космическая техника

53 Materials handling equipment / Подъемно-транспортное оборудование

55 Packaging and distribution of goods / Упаковка и размещение грузов

59 Textile and leather technology / Текстильное и кожевенное производство

61 Clothing industry / Швейная промышленность

65 Agriculture / Сельское хозяйство

67 Food technology / Производство пищевых продуктов

71 Chemical technology / Химическая промышленность

73 Mining and minerals / Горное дело и полезные ископаемые

75 Petroleum and related technologies / Добыча и переработка нефти, газа и смежные производства

77 Metallurgy / Металлургия

79 Wood technology / Технология переработки древесины

81 Glass and ceramics industries / Стекольная и керамическая промышленность

83 Rubber and plastic industries / Резиновая и пластмассовая промышленность

85 Paper technology / Целлюлозно-бумажная промышленность

87 Paint and colour industries / Лакокрасочная промышленность

91 Construction materials and building / Строительные материалы и строительство

93 Civil engineering / Гражданское строительство

95 Military engineering / Военная техника

97 Domestic and commercial equipment. Entertainment. Sports / Бытовая техника и торговое оборудование. Отдых. Спорт

CIS/A Radio-interference measurements and statistical methods /

CIS/B Interference relating to industrial, scientific and medical radio-frequency apparatus, to other (heavy) industrial equipment, to overhead power lines, to high voltage equipment and to electric traction /

CIS/D Electromagnetic disturbances related to electric/electronic equipment on vehicles and internal combustion engine powered devices /

CIS/F Interference relating to household appliances tools, lighting equipment and similar apparatus /

CIS/H Limits for the protection of radio services /

CIS/I Electromagnetic compatibility of information technology equipment, multimedia equipment and receivers /

CIS/S Steering Committee of CISPR /

CISPR International special committee on radio interference /

ISO/IEC JTC 1/SC 2 Coded character sets /

ISO/IEC JTC 1/SC 6 Telecommunications and information exchange between systems /

ISO/IEC JTC 1/SC 7 Software and systems engineering /

ISO/IEC JTC 1/SC 17 Cards and personal identification /

ISO/IEC JTC 1/SC 22 Programming languages, their environments and system software interfaces /

ISO/IEC JTC 1/SC 23 Digitally Recorded Media for Information Interchange and Storage /

ISO/IEC JTC 1/SC 24 Computer graphics, image processing and environmental data representation /

ISO/IEC JTC 1/SC 25 Interconnection of information technology equipment /

ISO/IEC JTC 1/SC 27 IT security techniques /

ISO/IEC JTC 1/SC 28 Office equipment /

ISO/IEC JTC 1/SC 29 Coding of audio, picture, multimedia and hypermedia information /

ISO/IEC JTC 1/SC 31 Automatic identification and data capture techniques /

ISO/IEC JTC 1/SC 32 Data management and interchange /

ISO/IEC JTC 1/SC 34 Document description and processing languages /

ISO/IEC JTC 1/SC 35 User interfaces /

ISO/IEC JTC 1/SC 36 Information technology for learning, education and training /

ISO/IEC JTC 1/SC 37 Biometrics /

ISO/IEC JTC 1/SC 38 Cloud Computing and Distributed Platforms /

ISO/IEC JTC 1/SC 39 Sustainability for and by Information Technology /

ISO/IEC JTC 1/SC 40 IT Service Management and IT Governance /

ISO/IEC JTC 1/SC 41 Internet of Things and related technologies /

ISO/IEC JTC 1 Information technology /

PC 118 Smart grid user interface /

SC 3C Graphical symbols for use on equipment /

SC 3D Product properties and classes and their identification /

SC 8A Grid Integration of Renewable Energy Generation /

SC 8B Decentralized Electrical Energy Systems /

SC 17A Switching devices /

SC 17C Assemblies /

SC 18A Electric cables for ships and mobile and fixed offshore units /

SC 21A Secondary cells and batteries containing alkaline or other non-acid electrolytes /

SC 22E Stabilized power supplies /

SC 22F Power electronics for electrical transmission and distribution systems /

SC 22G Adjustable speed electric drive systems incorporating semiconductor power converters /

SC 22H Uninterruptible power systems (UPS) /

SC 23A Cable management systems /

SC 23B Plugs, socket-outlets and switches /

SC 23E Circuit-breakers and similar equipment for household use /

SC 23G Appliance couplers /

SC 23H Plugs, Socket-outlets and Couplers for industrial and similar applications, and for Electric Vehicles /

SC 23J Switches for appliances /

SC 23K Electrical Energy Efficiency products /

SC 31G Intrinsically-safe apparatus /

SC 31J Classification of hazardous areas and installation requirements /

SC 31M Non-electrical equipment and protective systems for explosive atmospheres /

SC 32A High-voltage fuses /

SC 32B Low-voltage fuses /

SC 32C Miniature fuses /

SC 34B Lamp caps and holders /

SC 34C Auxiliaries for lamps /

SC 34D Luminaires /

SC 36A Insulated bushings /

SC 37A Low-voltage surge protective devices /

SC 37B Components for low-voltage surge protection /

SC 45A Instrumentation, control and electrical systems of nuclear facilities /

SC 45B Radiation protection instrumentation /

SC 46A Coaxial cables /

SC 46C Wires and symmetric cables /

SC 46F RF and microwave passive components /

SC 47A Integrated circuits /

SC 47D Semiconductor devices packaging /

SC 47E Discrete semiconductor devices /

SC 47F Micro-electromechanical systems /

SC 48B Electrical connectors /

SC 48D Mechanical structures for electronic equipment /

SC 59A Electric dishwashers /

SC 59C Heating appliances /

SC 59D Performance of household and similar electrical laundry appliances /

SC 59F Surface cleaning appliances /

SC 59K Performance of household and similar electrical cooking appliances /

SC 59L Small household appliances /

SC 59M Performance of electrical household and similar cooling and freezing appliances /

SC 61B Safety of microwave appliances for household and commercial use /

SC 61C Safety of refrigeration appliances for household and commercial use /

SC 61D Appliances for air-conditioning for household and similar purposes /

SC 61H Safety of electrically-operated farm appliances /

SC 61J Electrical motor-operated cleaning appliances for commercial use /

SC 62A Common aspects of electrical equipment used in medical practice /

SC 62B Diagnostic imaging equipment /

SC 62C Equipment for radiotherapy, nuclear medicine and radiation dosimetry /

SC 62D Electromedical equipment /

SC 65A System aspects /

SC 65B Measurement and control devices /

SC 65C Industrial networks /

SC 65E Devices and integration in enterprise systems /

SC 77A EMC - Low frequency phenomena /

SC 77B High frequency phenomena /

SC 77C High power transient phenomena /

SC 86A Fibres and cables /

SC 86B Fibre optic interconnecting devices and passive components /

SC 86C Fibre optic systems and active devices /

SC 121A Low-voltage switchgear and controlgear /

SC 121B Low-voltage switchgear and controlgear assemblies /

SyC AAL Active Assisted Living /

SyC LVDC Low Voltage Direct Current and Low Voltage Direct Current for Electricity Access /

SyC Smart Cities Electrotechnical aspects of Smart Cities /

SyC Smart Energy Smart Energy /

TA 1 Terminals for audio, video and data services and contents /

TA 2 Colour measurement and management /

TA 4 Digital system interfaces and protocols /

TA 5 Cable networks for television signals, sound signals and interactive services /

TA 6 Storage media, storage data structures, storage systems and equipment /

TA 8 Multimedia home systems and applications for end-user network /

TA 10 Multimedia e-publishing and e-book technologies /

TA 11 Quality for audio, video and multimedia systems /

TA 12 AV energy efficiency and smart grid applications /

TA 13 Environment for AV and multimedia equipment (tentative title /

TA 14 Interfaces and methods of measurement for personal computing equipment /

TA 15 Wireless Power Transfer /

TA 16 Active Assisted Living (AAL), accessibility and user interfaces /

TA 17 Multimedia systems and equipment for cars /

TC 1 Terminology /

TC 2 Rotating machinery /

TC 3 Information structures and elements, identification and marking principles, documentation and graphical symbols /

TC 4 Hydraulic turbines /

TC 5 Steam turbines /

TC 7 Overhead electrical conductors /

TC 8 Systems aspects for electrical energy supply /

TC 9 Electrical equipment and systems for railways /

TC 10 Fluids for electrotechnical applications /

TC 11 Overhead lines /

TC 13 Electrical energy measurement and control /

TC 14 Power transformers /

TC 15 Solid electrical insulating materials /

TC 17 High-voltage switchgear and controlgear /

TC 18 Electrical installations of ships and of mobile and fixed offshore units /

TC 20 Electric cables /

TC 21 Secondary cells and batteries /

TC 22 Power electronic systems and equipment /

TC 23 Electrical accessories /

TC 25 Quantities and units /

TC 26 Electric welding /

TC 27 Industrial electroheating and electromagnetic processing /

TC 28 Insulation co-ordination /

TC 29 Electroacoustics /

TC 31 Equipment for explosive atmospheres /

TC 33 Power capacitors and their applications /

TC 34 Lamps and related equipment /

TC 35 Primary cells and batteries /

TC 36 Insulators /

TC 37 Surge arresters /

TC 38 Instrument transformers /

TC 40 Capacitors and resistors for electronic equipment /

TC 42 High-voltage and high-current test techniques /

TC 44 Safety of machinery - Electrotechnical aspects /

TC 45 Nuclear instrumentation /

TC 46 Cables, wires, waveguides, RF connectors, RF and microwave passive components and accessories /

TC 47 Semiconductor devices /

TC 48 Electrical connectors and mechanical structures for electrical and electronic equipment /

TC 49 Piezoelectric, dielectric and electrostatic devices and associated materials for frequency control, selection and detection /

TC 51 Magnetic components, ferrite and magnetic powder materials /

TC 55 Winding wires /

TC 56 Dependability /

TC 57 Power systems management and associated information exchange /

TC 59 Performance of household and similar electrical appliances /

TC 61 Safety of household and similar electrical appliances /

TC 62 Electrical equipment in medical practice /

TC 64 Electrical installations and protection against electric shock /

TC 65 Industrial-process measurement, control and automation /

TC 66 Safety of measuring, control and laboratory equipment /

TC 68 Magnetic alloys and steels /

TC 69 Electric road vehicles and electric industrial trucks /

TC 70 Degrees of protection provided by enclosures /

TC 72 Automatic electrical controls /

TC 73 Short-circuit currents /

TC 76 Optical radiation safety and laser equipment /

TC 77 Electromagnetic compatibility /

TC 78 Live working /

TC 79 Alarm and electronic security systems /

TC 80 Maritime navigation and radiocommunication equipment and systems /

TC 81 Lightning protection /

TC 82 Solar photovoltaic energy systems /

TC 85 Measuring equipment for electrical and electromagnetic quantities /

TC 86 Fibre optics /

TC 87 Ultrasonics /

TC 88 Wind energy generation systems /

TC 89 Fire hazard testing /

TC 90 Superconductivity /

TC 91 Electronics assembly technology /

TC 94 All-or-nothing electrical relays /

TC 95 Measuring relays and protection equipment /

TC 96 Transformers, reactors, power supply units, and combinations thereof /

TC 97 Electrical installations for lighting and beaconing of aerodromes /

TC 99 System engineering and erection of electrical power installations in systems with nominal voltages above 1 kV a.c. and 1,5 kV d.c., particularly concerning safety aspects /

TC 100 Audio, video and multimedia systems and equipment /

TC 101 Electrostatics /

TC 103 Transmitting equipment for radiocommunication /

TC 104 Environmental conditions, classification and methods of test /

TC 105 Fuel cell technologies /

TC 106 Methods for the assessment of electric, magnetic and electromagnetic fields associated with human exposure /

TC 107 Process management for avionics /

TC 108 Safety of electronic equipment within the field of audio/video, information technology and communication technology /

TC 109 Insulation co-ordination for low-voltage equipment /

TC 110 Electronic display devices /

TC 111 Environmental standardization for electrical and electronic products and systems /

TC 112 Evaluation and qualification of electrical insulating materials and systems /

TC 113 Nanotechnology for electrotechnical products and systems /

TC 114 Marine energy - Wave, tidal and other water current converters /

TC 115 High Voltage Direct Current (HVDC) transmission for DC voltages above 100 kV /

TC 116 Safety of motor-operated electric tools /

TC 117 Solar thermal electric plants /

TC 119 Printed Electronics /

TC 120 Electrical Energy Storage (EES) Systems /

TC 121 Switchgear and controlgear and their assemblies for low voltage /

TC 122 UHV AC transmission systems /

TC 123 Standardization of the management of assets in power systems /

TC 124 Wearable Electronic Devices and Technologies /

DIN EN ISO 13485:2016-08

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016

Изделия медицинские. Системы менеджмента качества. Требования к регулированию

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016

82 стр.

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Разработчик:

Зарубежные/DIN

ICS:

03.120.10 Quality management and quality assurance / Управление качеством и обеспечение качества, 11.040.01 Medical equipment in general / Медицинское оборудование в целом

Исправлен:

DIN EN ISO 13485 Berichtigung 1:2017-07

Взамен:

DIN EN ISO 13485:2012-11DIN EN ISO 13485:2015-05

Заменен на:

DIN EN ISO 13485:2021-12

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