Стандарт ÖNORM EN ISO 14607:2018-11

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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 /

ÖNORM EN ISO 14607:2018-11

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, corrected version 2018-08)

Действует

Печатная копияПечатное издание

Англ.: 240.78€

Немец.: 240.78€

240.78 € (включая НДС 20%)

Разработчик:

Зарубежные/ON

ICS:

11.040.40 Implants. Including pacemakers / Имплантаты для хирургии, протезирования и ортоптики. Включая кардиостимуляторы

Описание

This document specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.
Dieses Dokument legt besondere Anforderungen an Mammaimplantate fest.
Im Hinblick auf die Sicherheit legt dieses Dokument Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designbewertung, Herstellung, Verpackung, Sterilisation und vom Hersteller zu liefernde Informationen fest.

Ключевые слова:

Implantat, Herstellerangabe, Längenänderung, Gel, Material, Etikettierung, Information, Dehnbarkeit, Begriffe, Definition, chirurgisches Implantat, Diffusion, Kennzeichnung, klinisch, Konstruktion, Evaluierung, Aufprall, Anforderung, Abrieb, Beipackzettel, inaktiv, Chirurgie, Kohäsion, biologische Gefährdung, Oberfläche, CE-Kennzeichnung, Konstruktionsmerkmal, Reißfestigkeit, Mechanik, mechanische Prüfung, Medizin, medizinische Ausstattung, medizinisches Instrument, Medizinprodukt, Sterilisation, Bewertung, Sicherheitsanforderung, Volumen, Brust, Gewebe, Prüfung, Naht, Werkstoff, Prüfverfahren, Verpackung, Ventil, Herstellung, Silikon, Sicherheit, Kontrolle, Zustand

Взамен:

ÖNORM EN ISO 14607:2017ÖNORM EN ISO 14607:2009

Ссылочные документы:

ISO 34-1:2015ISO 37:2017ISO 4287ISO 7619-1ISO 10993-1ISO 10993-5ISO 10993-18ISO 11607-1ISO 14155ISO 14630:2012ASTM D412-16ASTM D624-00:2012ASTM D792-13ASTM D2240-15

На это издание ссылаются: