ГОСТ Р МЭК 62366-1-2021. Национальный стандарт Российской Федерации. Изделия медицинские. Часть 1. Проектирование медицинских изделий с учетом эксплуатационной пригодности

[1]

IEC 60601-1:2005 <1>

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Изделия медицинские электрические. Часть 1. Общие требования безопасности с учетом основных функциональных характеристик)

IEC 60601-1:2005/Amd 1:2012

[2]

IEC 60601-1-6:2010 <2>

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Изделия медицинские электрические. Часть 1-6. Общие требования безопасности с учетом основных функциональных характеристик. Дополнительный стандарт. Эксплуатационная пригодность)

IEC 60601-1-6:2010/Amd. 1:2013

[3]

IEC 60601-1-8:2006 <3>

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Изделия медицинские электрические. Часть 1-8. Общие требования безопасности с учетом основных функциональных характеристик. Дополнительный стандарт: Общие требования к сигнальным системам)

IEC 60601-1-8:2006/Amd 1:2012

[4]

IEC 60601-1-11: <4>

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Изделия медицинские электрические. Часть 1-11. Общие требования безопасности с учетом основных функциональных характеристик. Дополнительный стандарт. Требования к изделиям медицинским электрическим и медицинским электрическим системам, используемым для создания в помещении медицинской среды)

[5]

IEC TR 61258:2008

Guidelines for the development and use of medical electrical equipment educational materials (Руководство по разработке и использованию медицинских электрических изделий в обучающих материалах)

[6]

ISO/IEC Guide 63:2012

Guide to the development and inclusion of safety aspects in International Standards for medical devices (Руководство по разработке и включению аспектов безопасности в международные стандарты на медицинские изделия)

[7]

ISO 7010:2011

Graphical symbols - Safety colours and safety signs - Registered safety signs (Графические символы. Цветовые и звуковые сигналы опасности)

[8]

ISO 9000:2005

Quality management systems - Fundamentals and vocabulary (Системы менеджмента качества. Основные положения и словарь)

[9]

ISO 9001:2008

Quality management systems - Requirements (Системы менеджмента качества. Требования)

[10]

ISO 9241-11:1998

Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (Эргономические требования к офисным дисплеям. Руководство по юзабилити)

[11]

ISO 13485:2003

Medical devices - Quality management system - Requirements for regulatory purposes (Изделия медицинские. Системы менеджмента качества. Требования для целей регулирования)

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ISO/TR 16142:2006

Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices (Изделия медицинские. Руководство по выбору стандартов в поддержку признанных важнейших принципов обеспечения безопасности и функциональных характеристик медицинских изделий)

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ANSI/AAMI HE 48:1993

Human factors engineering guidelines and preferred practices for the design of medical devices

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ANSI/AAMI HE 74:2001

Human factors design process for medical devices

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ANSI/AAMI HE 75:2009

Human factors engineering - Design of medical devices

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EN 1041:2008

Information supplied by the manufacturer of medical devices (Изделия медицинские. Информация, предоставляемая изготовителем) Amd. 1:2013

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Global Harmonization Task Force (GHTF), Study Group 2 (SG2), Medical Device Post Market Vigilance and Surveillance: Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative

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