Término solicitado: USABILIDAD/(265,65,175)
7 Registro/s encontrado/s en CAT+NORMA
| 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 |
| 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 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
| Código de Doc.: | IEC 60601-1-6 Amendment 1 |
| Autor Inst.: | International Electrotechnical Commission. IEC/CEI |
| Fecha: | 2013 |
| Estado: | |
| ICS: | 11.040 Medical equipment |
| Idioma: | en |
| Título en otro Idioma: | Amendement 1 - 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: | 12p. |
| Ingreso de la Info.: | 2014-02-12 |
| 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 1-6: 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) |
| Tipo de documento: | NORMA |
| Título: | EASE OF OPERATION OF EVERYDAY PRODUCTS -- PART 3: TEST METHOD FOR CONSUMER PRODUCTS |
| Código de Doc.: | ISO/PAS 20282-3 |
| Autor Inst.: | International Organization for Standardization. ISO |
| Fecha: | 2007 |
| Estado: | Para datos sobre la vigencia de esta norma haga clic aquí |
| Objeto: | ISO/PAS 20282-3:2007 specifies a test method for measuring the ease of operation of consumer products. The purpose of the test is to provide a basis for predicting the ease of operation of a consumer product, including measures of its effectiveness and efficiency of operation, and the satisfaction of the intended user population in the intended context of its use. The intended users of ISO/PAS 20282-3:2007 are people with human factors expertise in the design and management of appropriate tests, including manufacturers, suppliers, purchasing organizations and third parties such as consumer organizations |
| Relac. con otras Normas: | ISO 20282-1 |
| ICS: | 13.180 |
| Idioma: | en |
| Título en otro Idioma: | Facilité d'emploi des produits quotidiens -- Partie 3: Méthode d'essai pour produits de consommation courante |
| Edición: | first edition |
| Palabras Clave: | Diseño; Ergonomía del producto; Productos; Bienes de consumo; Operaciones; Productos de uso cotidiano; Usabilidad; Mediciones; Métodos de ensayo |
| Páginas: | 31p. |
| Ingreso de la Info.: | 2010-07-14 |
| Tipo de documento: | NORMA |
| Título: | EASE OF OPERATION OF EVERYDAY PRODUCTS -- PART 2: TEST METHOD FOR WALK-UP-AND-USE PRODUCTS |
| Código de Doc.: | ISO/TS 20282-2 |
| Autor Inst.: | International Organization for Standardization. ISO |
| Fecha: | 2006 |
| Estado: | Para datos sobre la vigencia de esta norma haga clic aquí |
| Objeto: | ISO 20282-2:2006 specifies a test method for measuring the ease of operation of "walk-up-and-use" products. The purpose of the test is to provide a basis for predicting the ease of operation of a walk-up-and-use product, including measures of its effectiveness and efficiency of operation, and the satisfaction of the intended user population in its expected context of use |
| Campo de Aplic.: | The intended users of ISO 20282-2:2006 are people with human factors expertise in the design and management of appropriate tests, including manufacturers, suppliers, purchasing organizations or third parties (such as consumer organizations) |
| Relac. con otras Normas: | ISO 20282-1 |
| ICS: | 13.180 |
| Idioma: | en |
| Título en otro Idioma: | Facilité d'emploi des produits quotidiens -- Partie 2: Méthode d'essai pour les produits grand public d'accès et d'utilisation immédiats |
| Edición: | first edition |
| Palabras Clave: | Diseño; Ergonomía del producto; Manipuleo; Operaciones; Productos de uso cotidiano; Usabilidad; Métodos de ensayo |
| Páginas: | 32p. |
| Ingreso de la Info.: | 2010-07-13 |
| Tipo de documento: | NORMA |
| Título: | EASE OF OPERATION OF EVERYDAY PRODUCTS -- PART 1: DESIGN REQUIREMENTS FOR CONTEXT OF USE AND USER CHARACTERISTICS |
| Código de Doc.: | ISO 20282-1 |
| Autor Inst.: | International Organization for Standardization. ISO |
| Fecha: | 2006 |
| Estado: | Para datos sobre la vigencia de esta norma haga clic aquí |
| Objeto: | ISO 20282-1:2006 provides requirements and recommendations for the design of easy-to-operate everyday products, where ease of operation addresses a subset of the concept of usability concerned with the user interface by taking account of the relevant user characteristics and the context of use. ISO 20282-1:2006 is intended to be used in the development of everyday products, for which it defines ease of operation, explains which aspects of the context of use are relevant, and describes the characteristics of the intended user population that may influence usability. The intended users of this part of ISO 20282-1:2006 are usability specialists, ergonomists, product designers, interaction designers, product manufacturers and others involved in the design and development of everyday products. ISO 20282-1:2006 is applicable to mechanical and/or electrical products with an interface that a user can operate directly or remotely to gain access to the functions provided. These products fall into at least one of the following categories: consumer products intended for some or all of the general public which are bought, rented or used, and which may be owned by individuals, public organizations, or private companies; consumer products intended to be acquired and used by an individual for personal rather than professional use (e.g. alarm clocks, electric kettles, telephones, electric drills); walk-up-and-use products that provide a service to the general public (such as ticket-vending machines, photocopying machines, fitness equipment); products used in a work environment, but not as part of professional activities (e.g. a coffee machine in an office); products including software that supports the main goals of use of the product (e.g. a CD player) |
| Campo de Aplic.: | This part of ISO 20282 is not applicable to the following: purely physical products without an interactive user interface (such as a jug or a hammer); products where appearance or fashion is the main goal (such as a watch with no markings); products requiring specialist training, specific skills and/or professional knowledge (such as a musical instrument or a car); standalone software products; products intended to be used for professional activities only |
| ICS: | 13.180 |
| Idioma: | en |
| Título en otro Idioma: | Facilité d'emploi des produits quotidiens -- Partie 1: Exigences de conception pour le contexte d'utilisation et pour les caractéristiques de l'utilisateur |
| Edición: | first edition |
| Palabras Clave: | Diseño; Ergonomía del producto; Manipuleo; Operaciones; Productos de uso cotidiano; Usabilidad; Requisitos |
| Páginas: | 27p. |
| Ingreso de la Info.: | 2010-07-13 |
Fin
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