| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTSFOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOMAGRAPHIC STEREOTACTIC DEVICES |
| Código de Doc.:
|
IEC 60601-2-45:2011+AMD1:2015 CSV Consolidated version |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2015 |
| Estado: |
|
| Objeto:
|
IEC 60601-2-45:2011+A1:2015 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment. This consolidated version consists of the third edition (2011) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication. |
| ICS:
|
11.040.50 - Radiographic equipment |
| Idioma:
|
en |
| Edición:
|
Edition 3.1 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Rayos x;
Radiografia;
Radiologia
|
| Páginas:
|
110p. |
| Ingreso de la Info.:
|
2019-08-23 |
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Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE SAFETY, INCLUDING ESSENTIAL PERFORMANCE, OF AUTOMATIC CYCLING NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT |
| Código de Doc.:
|
IEC 60601-2-30 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
1999 |
| Estado: |
|
| Objeto:
|
Specifies particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment, with special attention being paid to the avoidance of hazards due to the inflation process |
| ICS:
|
11.040.01 - Medical equipment in general |
| Idioma:
|
en |
| Título en otro Idioma:
|
Appareils electromedicaux. Regles particulieres de securite et performances essentielles des appareils de surveillance de la pression sanguine prelevee indirectement, automatiquement et periodiquement |
| Edición:
|
Edition 2.0 |
| Notas:
|
This publication has been replaced by IEC 80601-2-30:2009 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos eléctricos;
Seguridad eléctrica;
Mediciones;
Performance;
Monitoreo
|
| Páginas:
|
48p. |
| Ingreso de la Info.:
|
2017-01-25 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
AMENDMENT 1 - MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| Código de Doc.:
|
IEC 62366: 2007 Amendment 1 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2014 |
| Estado: |
|
| Objeto:
|
IEC 62366:2007+A1:2014 Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device |
| ICS:
|
11.040 Medical equipment |
| Idioma:
|
en |
| Título en otro Idioma:
|
Amendement 1 - Dispositif médicaux - Applications de l'ingenierie de l'aptitude à l'utilisation aux dispositif médicaux |
| Edición:
|
Edition 1.1 |
| Notas:
|
This consolidated version consists of the first edition (2007) and its amendment 1 (2014). Therefore, no need to order amendment in addition to this publication |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Riegos;
Validación;
Usabilidad
|
| Páginas:
|
16p. |
| Ingreso de la Info.:
|
2015-02-19 |
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|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| Código de Doc.:
|
IEC 60601-1-2 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2014 |
| Estado: |
|
| Objeto:
|
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 disturbances and to electromagnetic disturbances emitted by me equipment and me systems. This collateral standard to IEC 60601-1 specifies general requirements and tests for basic safety and essential performance with regard to electromagnetic disturbances and for electromagnetic emissions of ME equipment and ME systems. 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: specification of immunity test levels according to the environments of intended use, categorized according to locations that are harmonized with IEC 60601-1-11: the professional healthcare facility environment, the home healthcare environment and special environments;specification of tests and test levels to improve the safety of medical electrical equipment and medical electrical systems when portable RF communications equipment is used closer to the medical electrical equipment than was recommended based on the immunity test levels that were specified in the third edition; specification of immunity tests and immunity test levels according to the ports of the medical electrical equipment or medical electrical system; specification of immunity test levels based on the reasonably foreseeable maximum level of electromagnetic disturbances in the environments of intended use, resulting in some immunity test levels that are higher than in the previous edition; and better harmonization with the risk concepts of basic safety and essential performance, including deletion of the defined term "life-supporting". This new edition includes the following main additions: guidance for determination of immunity test levels for special environments; guidance for adjustment of immunity test levels when special considerations of mitigations or intended use are applicable; guidance on risk management for basic safety and essential performance with regard to electromagnetic disturbances; and guidance on identification of immunity pass/fail criteria |
| ICS:
|
11.040.01 Medical equipment in general, 33.100.10 Emission, 33.100.20 Immunity |
| Idioma:
|
en |
| Título en otro Idioma:
|
Appareils électromédicaux - Partie 1-2: Exigences particulières pour la sécurité de base et les performances essentielles - Norme collatérale: Perturbation électromagnétiques - Exigences et essais |
| Edición:
|
Edition 4.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Performance;
Perturbaciones electromagnéticas;
Métodos de ensayo;
Emisiones;
Inmunidad
|
| Páginas:
|
47p. |
| Ingreso de la Info.:
|
2015-02-12 |
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|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
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 |
| Código de Doc.:
|
IEC 60601-1-11 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2010 |
| Estado: |
|
| Objeto:
|
IEC 60601-1-8:2006+A1:2012 Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems. This consolidated version consists of the second edition (2006) and its amendment 1 (2012). Therefore, no need to order amendment in addition to this publication |
| ICS:
|
11.040.10 |
| Idioma:
|
en;fr |
| Título en otro Idioma:
|
Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles - Norme collateralle: Exigences pour les appareils et des systemes électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile |
| Edición:
|
Edition 1.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Salud;
Asistencia médica domiciliaria
|
| Páginas:
|
117p. |
| Ingreso de la Info.:
|
2013-08-09 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
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 |
| Código de Doc.:
|
IEC 60601-1-8:2006 A1 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2012 |
| Estado: |
|
| Objeto:
|
IEC 60601-1-8:2006+A1:2012 Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems. This consolidated version consists of the second edition (2006) and its amendment 1 (2012). Therefore, no need to order amendment in addition to this publication |
| ICS:
|
11.040.01 Medical equipment in general |
| Idioma:
|
en;fr |
| Título en otro Idioma:
|
Amendement 1: Appareils électromédicaux - Partie 1-8: Exigences particulières pour la sécurité de base et les performances essentielles - Norme collateralle: Exigences générale, essais et guide pour les systémes d'alarme des appareils et des systemes électromédicaux |
| Edición:
|
Edition 2.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Alarmas;
Sistemas de alarma;
Señales
|
| Páginas:
|
58p. |
| Ingreso de la Info.:
|
2013-08-15 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
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 |
| Código de Doc.:
|
IEC 60601-1-11 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2010 |
| Estado: |
|
| Objeto:
|
IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards. It is therecommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication |
| ICS:
|
11.040.10 |
| Título en otro Idioma:
|
Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles - Norme collateralle: Exigences pour les appareils et des systemes électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile |
| Edición:
|
Edition 1.0 |
| Notas:
|
Adjunta CORRIGENDUM 1: IEC 60601-1-11/Cor 1:2011 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Salud;
Asistencia médica domiciliaria
|
| Páginas:
|
117p. |
| Ingreso de la Info.:
|
2013-08-09 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
GENERAL TESTING PROCEDURES FOR MEDICAL ELECTRICAL EQUIPMENT |
| Código de Doc.:
|
IEC/TR 62354 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2009 |
| Estado: |
|
| Objeto:
|
IEC/TR 62354:2009(E) provides guidance on general testing procedures according to IEC 60601-1:1988, IEC 60601-1-1:2000 and IEC 60601-1:2005. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. Several tests have been updated and additional test procedures and informative annexes added |
| ICS:
|
11.040 Medical equipment |
| Idioma:
|
en |
| Edición:
|
Edition 2.0 |
| Notas:
|
Para la consulta de esta norma dirigirse a INTI-Electrónica e Informática. This technical report is to be read in conjunction with IEC 60601-1:1988, IEC 60601-1-1:2000 and IEC 60601-1:2005 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Riegos
|
| Páginas:
|
206p. |
| Ingreso de la Info.:
|
2012-09-10 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
| Código de Doc.:
|
IEC 62366 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2007 |
| Estado: |
|
| Objeto:
|
Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device |
| ICS:
|
11.040 Medical equipment |
| Idioma:
|
en |
| Edición:
|
Edition 1.0 |
| Notas:
|
Para la consulta de esta norma dirigirse a INTI-Electrónica e Informática |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Riegos;
Validación;
Usabilidad
|
| Páginas:
|
209p. |
| Ingreso de la Info.:
|
2012-09-10 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| Código de Doc.:
|
IEC 60601-1 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2012 |
| Estado: |
|
| Objeto:
|
IEC 60601-1:2005+A1:2012(E) contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008 and the interpretation sheet 2 of January 2009 have been included in this copy |
| ICS:
|
11.040 Medical equipment |
| Idioma:
|
en |
| Edición:
|
Edition 3.1 |
| Notas:
|
Para la consulta de esta norma dirigirse a INTI-Electrónica e Informática |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Riegos
|
| Páginas:
|
415p. |
| Ingreso de la Info.:
|
2012-09-10 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-10: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF NERVE AND MUSCLE STIMULATORS |
| Código de Doc.:
|
IEC 60601-2-10 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2012 |
| Estado: |
|
| Objeto:
|
IEC 60601-2-10:2012 specifies the requirements for the safety and essential performance of nerve and muscle stimulators, for use in the practice of physical medicine. This includes transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS). This second edition cancels and replaces the first edition, published in 1987 and its Amendment 1 (2001). This edition constitutes a technical revision and is aligned with IEC 60601-1:2005+A1:2012 |
| ICS:
|
11.040.60 Therapy equipment |
| Idioma:
|
en;fr |
| Título en otro Idioma:
|
Appareils électromédicaux -- Partie 2-10: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs de nerfs et des muscles |
| Edición:
|
Edition 2.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Electroterapia;
Electroestimuladores;
Músculos;
Nervios
|
| Páginas:
|
42p. |
| Ingreso de la Info.:
|
2012-08-28 |
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|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-23: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF TRANSCUTANEOUS PARTIAL PRESSURE MONITORING EQUIPMENT |
| Código de Doc.:
|
IEC 60601-2-23 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2011 |
| Estado: |
|
| Objeto:
|
IEC 60601-2-23:2011 applies to the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. It applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. IEC 60601-2-23:2011 does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa). This third edition cancels and replaces the second edition published in 1999 and constitutes a technical revision. This edition of IEC 60601-2-23 was revised to align structurally with the 2005 edition of IEC 60601-1 |
| ICS:
|
11.040.55 Diagnostic equipment |
| Idioma:
|
en |
| Título en otro Idioma:
|
Appareils electromedicaux. Regles particulieres de securite et performances essentielles des appareils de surveillance de la pression partielle transcutanee |
| Edición:
|
Edition 3.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Monitores de pacientes;
Presión;
Mediciones de presión;
Dióxido de carbono;
Equipos trancutáneo
|
| Páginas:
|
98p. |
| Ingreso de la Info.:
|
2012-08-17 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-6: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MICROWAVE THERAPY EQUIPMENT |
| Código de Doc.:
|
IEC 60601-2-6 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2012 |
| Estado: |
|
| Objeto:
|
IEC 60601-2-6:2012 specifies the minimum requirements considered to provide for a practical degree of safety in the operation of microwave therapy equipment. This particular standard amends and supplements IEC 60601-1 (third edition, 2005 and amendment 1, 2012). This second edition cancels and replaces the first edition of IEC 60601-2-6, published in 1984. This edition constitutes a technical revision and has been aligned to the third edition of IEC 60601-1:2005+A1:2012 |
| ICS:
|
11.040.60 Therapy equipment |
| Idioma:
|
en;fr |
| Título en otro Idioma:
|
Appareils électromédicaux -- Partie 2-6: Exigences particulières de sécurité de base et de performances essentielles des appareils de thérapie à micro-ondes |
| Edición:
|
Edition 2.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Electroterapia;
Microondas
|
| Páginas:
|
41p. |
| Ingreso de la Info.:
|
2012-06-8 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-3: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SHORT-WAVE THERAPY EQUIPMENT |
| Código de Doc.:
|
IEC 60601-2-3 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2012 |
| Estado: |
|
| Objeto:
|
IEC 60601-2-3:2012 specifies the requirements for the basic safety and essential performance of short-wave therapy equipment. Short-wave therapy equipment are defined as medical equipment for the therapeutic treatment of a patient by exposure to electric or magnetic fields produced in the frequency range of more than 13 MHz but not exceeding 45 MHz. Equipment having a rated output power not exceeding 10 W are exempted from certain requirements of this standard. This third edition cancels and replaces the second edition of IEC 60601-2-3 published in 1991 and its amendment 1 published in 1998. This edition constitutes a technical revision and has been aligned with IEC 60601-1:2005 |
| ICS:
|
11.040.60 Therapy equipment |
| Idioma:
|
en;fr |
| Título en otro Idioma:
|
Appareils électromédicaux -- Partie 2-3: Exigences particulières de sécurité de base et de performances essentielles des appareils de théraphie à ondes courtes |
| Edición:
|
Edition 3.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Electroterapia;
Onda corta
|
| Páginas:
|
46p. |
| Ingreso de la Info.:
|
2012-06-7 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
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 |
| Código de Doc.:
|
IEC 60601-1-8 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2006 |
| Estado: |
|
| Objeto:
|
Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems |
| ICS:
|
11.040.01 Medical equipment in general |
| Idioma:
|
en;fr |
| Título en otro Idioma:
|
Appareils électromédicaux - Partie 1-8: Exigences particulières pour la sécurité de base et les performances essentielles - Norme collateralle: Exigences générale, essais et guide pour les systémes d'alarme des appareils et des systemes électromédicaux |
| Edición:
|
Edition 2.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Alarmas;
Sistemas de alarma;
Señales
|
| Páginas:
|
157p. |
| Ingreso de la Info.:
|
2012-04-04 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS |
| Código de Doc.:
|
IEC 60601-2-4 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2010 |
| Estado: |
|
| Objeto:
|
IEC 60601-2-4:2010 establishes particular basic safety and essential performance requirements for cardiac defibrillators. This third edition cancels and replaces the second edition published in 2002. This edition constitutes a technical revision, revised to structurally align it with IEC 60601-1:2005 and to implement the decision of IEC SC 62A that the clause numbering structure of particular standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The aim of this third edition is to bring this particular standard up to date with reference to the third edition of the general standard through reformatting and technical changes |
| ICS:
|
11.040.10 Anaesthetic, respiratory and reanimation equipment |
| Idioma:
|
en |
| Título en otro Idioma:
|
Appareils électromédicaux -- Partie 2-52: Exigences particulières de sécurité de base et de performances essentielles des défibrillateurs cardiaques |
| Edición:
|
Edition 3.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Desfibriladores cardíacos
|
| Páginas:
|
156p. |
| Ingreso de la Info.:
|
2012-04-03 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
| Tipo de documento:
|
NORMA |
| Título:
|
MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
| Código de Doc.:
|
IEC 60601-1-6 |
| Autor Inst.:
|
International Electrotechnical Commission. IEC/CEI |
| Fecha:
|
2010 |
| Estado: |
|
| Objeto:
|
IEC 60601-1-6:2010 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production |
| ICS:
|
11.040 Medical equipment |
| Idioma:
|
en |
| Título en otro Idioma:
|
Appareils électromédicaux - Partie 1-6: Exigences particulières pour la sécurité de base et les performances essentielles - Norme collateralle: Aptitude à l'utilisation |
| Edición:
|
Edition 3.0 |
| Palabras Clave: |
Medicina;
Equipos electromédicos;
Equipos médicos;
Requisitos;
Seguridad;
Normas;
Validación;
Usabilidad
|
| Páginas:
|
51p. |
| Ingreso de la Info.:
|
2012-04-03 |
|
|
Para ver la norma completa busque en la base Normas (solo para personal del INTI) |
