IEC/TR 60513

Edition 2.0 (1994-01-08)

Fundamental aspects of safety standards for medical electrical equipment

Stability Date: 2013

IEC 60601-1

Edition 3.0 (2005-12-15)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Stability Date: 2019

IEC 60601-1

Edition 3.0 (2006-12-12)

Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Stability Date: 2019

IEC 60601-1

Edition 3.0 (2007-12-07)

Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Stability Date: 2019

IEC 60601-1

Edition 3.0 (2008-04-25)

Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Stability Date: 2019

IEC 60601-1

Edition 3.0 (2009-01-28)

Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Stability Date: 2019

IEC 60601-1

Edition 3.1 (2012-08-20)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1

Edition 3.1 (2012-11-14)

Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1

Edition 3.0 (2005-12-15)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Stability Date: 2019

IEC 60601-1

Edition 3.0 (2005-12-15)

Stability Date: 2019

IEC 60601-1

Edition 3.0 (2005-12-15)

Versión Oficial En español (Equipos electromédicos. Parte 1: Requisitos gener) 1: Requisitos generales para la seguridad básica y funcionamiento esencial. Incluye CORR.1 de diciembre 2006 y CORR.2 de diciembre 2007

Stability Date: 2019

IEC 60601-1-am1

Edition 3.0 (2012-07-13)

Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Stability Date: 2019

IEC 60601-1-1

Edition 2.0 (2000-12-14)

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

Stability Date: 2013

IEC 60601-1-1

Edition 2.0 (2000-12-14)

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

Stability Date: 2013

IEC 60601-1-1

Edition 2.0 (2000-12-14)

Stability Date: 2013

IEC 60601-1-1

Edition 2.0 (2000-12-14)

Versión Oficial En español - Equipos electromédicos. Parte 1: Requisitos generales de seguridad. Sección Uno: Norma colateral: Requisitos de seguridad para sistemas electromédicos.

Stability Date: 2013

IEC 60601-1-2

Edition 3.0 (2007-03-30)

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Stability Date: 2012

IEC 60601-1-2

Edition 3.0 (2010-03-16)

Interpretation sheet 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Stability Date: 2012

IEC 60601-1-2

Edition 3.0 (2007-03-30)

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

Stability Date: 2012

IEC 60601-1-2

Edition 3.0 (2007-03-30)

Stability Date: 2012

IEC 60601-1-2

Edition 3.0 (2007-03-30)

Versión Oficial en Español - Equipos electromédicos. Parte 1-2: Requisitos generales para la seguridad básica y funcionamiento esencial. Norma colateral: Compatibilidad electromagnética. Requisitos y ensayos.

Stability Date: 2012

IEC 60601-1-6

Edition 3.0 (2010-01-27)

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Stability Date: 2015

IEC 60601-1-6

Edition 3.0 (2010-01-27)

Versión Oficial En español - Equipos electromédicos. Parte 1-6: Requisitos generales para la seguridad básica y funcionamiento esencial. Norma colateral: Aptitud de uso.

Stability Date: 2015

IEC 60601-1-8

Edition 2.1 (2012-11-28)

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

IEC 60601-1-8

Edition 2.0 (2006-10-25)

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

Stability Date: 2015

IEC 60601-1-8

Edition 2.0 (2006-10-25)

Versión Oficial en Español - Equipos electromédicos. Parte 1-8: Requisitos particulares para la seguridad básica y características de funcionamiento esencial. Norma colateral: Requisitos generales, ensayos y guía para los sistemas de alarma en equipos electromédicos y sistemas elect

Stability Date: 2015

IEC 60601-1-8-am1

Edition 2.0 (2012-11-28)

Amendment 1 - 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

Stability Date: 2015

IEC 60601-1-9

Edition 1.0 (2007-07-10)

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Stability Date: 2015

IEC 60601-1-9

Edition 1.0 (2007-07-10)

Versión Oficial En español - Equipos electromédicos. Parte 1-9: Requisitos generales para la seguridad básica y funcionamiento esencial. Norma colateral: Requisitos para un diseño eco-responsable.

Stability Date: 2015

IEC 60601-1-10

Edition 1.0 (2007-11-21)

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Stability Date: 2018

IEC 60601-1-10

Edition 1.0 (2007-11-21)

Versión Oficial En español - Equipos electromédicos. Parte 1-10: Requisitos generales para la seguridad básica y funcionamiento esencial. Norma colateral: Requisitos para el desarrollo de controladores fisiológicos en bucle cerrado.

Stability Date: 2018

IEC 60601-1-11

Edition 1.0 (2010-04-28)

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

Stability Date: 2015

IEC 60601-1-11

Edition 1.0 (2011-04-20)

Corrigendum 1 - 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

Stability Date: 2015

IEC 60601-1-SER

Edition 1.0 (2012-11-28)

Medical electrical equipment - ALL PARTS

IEC/TR 60878

Edition 2.0 (2003-07-07)

Graphical symbols for electrical equipment in medical practice

Stability Date: 2011

IEC/TR 60930

Edition 2.0 (2008-09-19)

Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems

Stability Date: 2014

IEC/TR 61258

Edition 2.0 (2008-08-28)

Guidelines for the development and use of medical electrical equipment educational materials

Stability Date: 2014

IEC/TR 62296

Edition 2.0 (2009-01-22)

Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements

Stability Date: 2017

IEC 62304

Edition 1.0 (2006-05-09)

Medical device software - Software life cycle processes

Stability Date: 2012

IEC 62304

Edition 1.0 (2006-05-09)

Medical device software - Software life cycle processes

Stability Date: 2012

IEC 62304

Edition 1.0 (2006-05-09)

Stability Date: 2012

IEC 62304

Edition 1.0 (2006-05-09)

Versión Oficial En español - Software de dispositivos médicos. Procesos del ciclo de vida del software

Stability Date: 2012

IEC/TR 62348

Edition 2.0 (2012-12-12)

Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

Stability Date: 2019

IEC 62353

Edition 1.0 (2007-05-15)

Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment

Stability Date: 2024

IEC 62353

Edition 1.0 (2007-05-15)

Versión Oficial En español - Equipos electromédicos. Ensayos recurrentes y ensayos después de reparación del equipo electromédico.

Stability Date: 2024

IEC/TR 62354

Edition 2.0 (2009-10-14)

General testing procedures for medical electrical equipment

Stability Date: 2013

IEC 62366

Edition 1.0 (2007-10-18)

Medical devices - Application of usability engineering to medical devices

Stability Date: 2012

IEC 62366

Edition 1.0 (2007-10-18)

Versión Oficial En español - Dispositivos médicos. Aplicación de la ingeniería de aptitud de uso a los dispositivos médicos.

Stability Date: 2012

IEC 80001-1

Edition 1.0 (2010-10-27)

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities

Stability Date: 2015

IEC 80001-1

Edition 1.0 (2010-10-27)

Versión Oficial en Español - Aplicación de la gestión del riesgo para las redes de tecnología de la información que incorporan dispositivos médicos. Parte 1: Funciones, responsabilidades y actividades.

Stability Date: 2015

IEC/TR 80001-2-1

Edition 1.0 (2012-07-10)

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples

Stability Date: 2015

IEC/TR 80001-2-2

Edition 1.0 (2012-07-10)

Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

Stability Date: 2015

IEC/TR 80001-2-3

Edition 1.0 (2012-07-10)

Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

Stability Date: 2015

IEC/TR 80001-2-4

Edition 1.0 (2012-11-29)

Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

Stability Date: 2015

IEC/TR 80002-1

Edition 1.0 (2009-09-23)

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

Stability Date: 2013