El período de transición de la 3ª edición de IEC 60601-1:2005 acabará el 1 de Junio de 2012. El estándar de "Equipos electromédicos - Parte 1: Requisitos generales para la seguridad básica y el funcionamiento esencial" entrará completamente en vigor. IEC 60601-1-12:2014 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. Ausgabedatum: 2014-06 Edition: 1.0 What is IEC 60601-1? Standards play a paramount role in product design and development. IEC 60601-1 is a series of technical standards for the safety and effectiveness of medical electrical equipment. The force of this standard is to require two level of protection to guard the patient and operator from any injury. It is recognized… In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1. This EN 60601-1:2006 has been significantly restructured compared to EN 60601-1:1990. 316.35 € Download/PDF Add to Cart National Version. IEC Standards Search . Abstract; IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic IEC 60601-1-12:2015. Medical Electrical Equipment -- Part 1-12: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment
IEC TC/SC 62A. Specifies requirements and tests for electromagnetic compatibility of equipment and systems and serves as the basis of electromagnetic compatibility requirements and tests in Particular Standards (60601-2-series).
11.040 IEC 60601-1(2005)/Cor.1(2006). Электроаппаратура медицинская. Часть 1. Общие требования к общей безопасности и существенные рабочие характеристики. Поправка 1. Стандарт IEC EN 60601-1 является базовым по безопасности электрического медицинского оборудования и родительским для более чем 60-ти других стандартов. ГОСТ IEC 60601-2-1-2011. Medical electrical equipment. Part 2-1. Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV. Copyright International Electrotechnical Commission Provided by IHS under license with IEC No reproduction or networking permitted without license from IHS. IEC 60417 Database Snapshot (2006-01-03). Pour marquer un convertisseur courant alternatif/courant continu et Настоящее приложение содержит сведения о связях между пунктами и подпунктами второго издания МЭК 60601-1-2 с изменением и сопоставимыми пунктами и подпунктами настоящего
Дополнительный стандарт устанавливает требования к процессам анализа, проектирования, верификации и валидации эксплуатационной пригодности, обеспечивающим безопасность медицинских электрических изделий.
IEC 60601-1. Result - Remark. Verdict. INSULATION DIAGRAM. TRF No. IEC60601_1H. Clause Requirement + Test. IEC 60601-1-1 является дополнительным стандартом по отношению к IEC 60601-1 «Изделия медицинские электрические. Часть 1. Общие требования безопасности» (далее – общий стандарт). Настоящий стандарт устанавливает требования к процессу разработки и его этапам Международный стандарт IEC 60601- тов есть основные требования, опреде- операционных столов. The International Electrotechnical Commission (IEC) in 2014 published the updated revision of the electromagnetic compatibility (EMC) requirements for medical devices, the IEC 60601-1-2:2014, so called 4th edition, with an effective date of April 1, 2017. This revision makes changes to immunity IEC 60601-1 provides general requirements, in a series of standards, that address the basic safety and essential performance requirements of medical electrical equipment. We will see how the standard has evolved, through to the 4th edition EMC collateral standard that establishes new “environments” when IEC TC/SC 62A. Specifies requirements and tests for electromagnetic compatibility of equipment and systems and serves as the basis of electromagnetic compatibility requirements and tests in Particular Standards (60601-2-series). The IEC 60601-1 states maximum requirements concerning the protection from electric shock for medical applications in which patients and
IEC 60601-1 Third Edition Amendment 1 (Ed. 3.1) What you need to know For manufacturers of medical electrical equipment and systems, IEC 60601-1 Edition 3.1 (or IEC 60601-1:2005+AMD1:2012) represents a significant departure from Edition 3.0 of the standard. While the application of risk management principles have been clarified, the amended standard includes new requirements regarding […]
Обозначение заменяемого в части. IEC 60601-1-6(2010). Дата опубликования. IEC 60601-1 has become the global benchmark for medical electrical equipment, and many companies view compliance with IEC 60601-1 as a de 11.040 IEC 60601-1(2005)/Cor.1(2006). Электроаппаратура медицинская. Часть 1. Общие требования к общей безопасности и существенные рабочие характеристики. Поправка 1.
ГОСТ IEC 60601-1-6-2011. Изделия медицинские электрические. Часть 1-6. Общие требования безопасности. Эксплуатационная пригодность. Обозначение заменяемого в части. IEC 60601-1-6(2010). Дата опубликования.
La IEC 60601-1:2005, y su versión A1 IEC 60601-1:2005 + A1: 2012, son cada vez más ampliamente aceptadas en los EE. UU., Canadá, UE, Japón, Brasil y Rusia. Algunos de los principales países de importación de equipos médicos imponen la implementación de la 3ª edición, porque reconocen este estándar como el estado actual de la técnica.
They are in addition to the requirements of the general standard IEC 60601-1 and serve as the basis for particular standards. This fourth edition cancels and replaces the third edition of IEC 60601-1-2, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: EN 60601-1 se aplica a todos los equipos eléctricos médicos y sistemas eléctricos médicos. El equipo eléctrico médico se define en la norma como un equipo eléctrico que tiene una parte aplicada o que transfiere energía al paciente o desde éste, o que detecta dicha transferencia de energía hacia o desde el paciente y que es:. Provisto con no más de una conexión a una red de IEC 60601-1 provides general requirements, in a series of standards, that address the basic safety and essential performance requirements of medical electrical equipment. We will see how the standard has evolved, through to the 4th edition EMC collateral standard that establishes new “environments”