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11.040.01: Медицинское оборудование в целом

Темы (или пункты), которые надо показать:

Стандарт и/или проектСтадия TC
ISO 14971:2007
Изделия медицинские. Применение менеджмента риска к медицинским изделиям
90.92 ISO/TC 210
ISO/NP 14971
Medical devices -- Application of risk management to medical devices
10.99 ISO/TC 210
ISO 15223-1:2016
Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
60.60 ISO/TC 210
ISO 15223-2:2010
Медицинские изделия. Символы, используемые на ярлыках медицинских изделий, при маркировке и в предоставляемой информации. Часть 2. Разработка, выбор и валидация символов
90.93 ISO/TC 210
ISO 15225:2016
Medical devices -- Quality management -- Medical device nomenclature data structure
60.60 ISO/TC 210
ISO 15378:2015
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
90.92 ISO/TC 76
ISO/DIS 15378
Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
40.20 ISO/TC 76
ISO 16142-1:2016
Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
60.60 ISO/TC 210
ISO/DIS 16142-2
Medical devices -- Recognized essential principles of safety and performance of medical devices -- Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
40.60 ISO/TC 210
ISO/PAS 18761:2013
Применение и обращение с медицинскими устройствами, подпадающими под область распространения ISO/TC 84. Оценка риска при кожно-слизистом контакте с кровью
90.93 ISO/TC 84
ISO/TS 19218-1:2011
Аппаратура медицинская. Иерархическая структура кодирования неблагоприятных событий. Часть 1. Коды типов событий
90.93 ISO/TC 210
ISO/TS 19218-1:2011/Amd 1:2013
Аппаратура медицинская. Иерархическая структура кодирования неблагоприятных событий. Часть 1. Коды типов событий. Изменение 1
60.60 ISO/TC 210
ISO/TS 19218-2:2012
Аппаратура медицинская. Иерархическая структура кодирования неблагоприятных событий. Часть 2. Коды оценки
90.93 ISO/TC 210
ISO/TR 19244:2014
Guidance on transition periods for standards developed by ISO/TC 84 -- Devices for administration of medicinal products and catheters
60.60 ISO/TC 84
ISO/CD 20069
Device change management of combination products for administration of medicinal products
30.00 ISO/TC 84
ISO/TR 24971:2013
Медицинская аппаратура. Руководство по применению ИСО 14971
60.60 ISO/TC 210
IEC 62304:2006
Medical device software -- Software life cycle processes
90.92 ISO/TC 210
IEC/CD 62304
Medical device software -- Software life cycle processes
30.00 ISO/TC 215
IEC 62304:2006/Amd 1:2015
60.60 ISO/TC 210
IEC 62366-1:2015
Medical devices -- Part 1: Application of usability engineering to medical devices
60.60 ISO/TC 210
IEC 62366-1:2015/Cor 1:2016
60.60 ISO/TC 210
IEC/TR 62366-2:2016
Medical devices -- Part 2: Guidance on the application of usability engineering to medical devices
60.60 ISO/TC 210
IEC/NP 80001-1
Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software -- Part 1: Application of risk management
10.99 ISO/TC 215
IEC 80001-1:2010
Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities
90.93 ISO/TC 215
IEC/TR 80001-2-1:2012
Application of risk management for IT-networks incorporating medical devices -- Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples
60.60 ISO/TC 215
IEC/TR 80001-2-2:2012
Application of risk management for IT-networks incorporating medical devices -- Part 2-2: Guidance for the communication of medical device security needs, risks and controls
60.60 ISO/TC 215
IEC/TR 80001-2-3:2012
Application of risk management for IT-networks incorporating medical devices -- Part 2-3: Guidance for wireless networks
60.60 ISO/TC 215
IEC/TR 80001-2-4:2012
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for Healthcare Delivery Organizations
60.60 ISO/TC 215
IEC/TR 80001-2-5:2014
Application of risk management for IT-networks incorporating medical devices -- Part 2-5: Application guidance -- Guidance for distributed alarm systems
60.60 ISO/TC 215
ISO/TR 80001-2-6:2014
Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
60.60 ISO/TC 215
IEC/TR 80001-2-8:2016
Application of risk management for IT-networks incorporating medical devices -- Part 2-8: Application guidance -- Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
60.60 ISO/TC 215
ISO/TR 80001-2-7:2015
Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
60.60 ISO/TC 215
IEC/DTR 80001-2-9
Application of risk management for IT-networks incorporating medical devices -- Part 2-9: Application guidance -- Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
30.99 ISO/TC 215
IEC/TR 80002-1:2009
Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
60.60 ISO/TC 210
ISO/DTR 80002-2
Medical device software -- Part 2: Validation of software for medical device quality systems
30.60 ISO/TC 210
IEC/TR 80002-3:2014
Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
60.60 ISO/TC 210