IEC/TC 62 - Electrical equipment in medical practice
To prepare international standards and other publications concerning electrical equipment, electrical systems and software used in healthcare and their effects on patients, operators, other persons and the environment. NOTE : This scope includes items that are also within the scopes of other committees and will be addressed through cooperation. Attention will focus on safety and performance (e.g. radiation protection, data security, data integrity, data privacy and environmental aspects) and will contribute to regulatory frameworks. Healthcare includes medical practice as well as emergency medical services, homecare, and support of persons with disabilities in their daily lives (i.e. Ambient Assisted Living).
Equipements électriques dans la pratique médicale
Etablir des normes internationales et d'autres publications concernant les appareils électriques, les systèmes électriques, et les logiciels, utilisés dans le domaine de la santé, ainsi que leurs effets sur les patients, les opérateurs, d'autres personnes et l'environnement. NOTE: Ce domaine d'activité couvre des sujets qui font aussi partie des domaines d'activité d'autres Comités d'Etudes, et sera traité à travers des collaborations. L'attention sera concentrée sur la sécurité et la performance (par exemple, protection contre les rayonnements, sécurité de données, intégrité de données, confidentialité de données et aspects environnementaux) et contribuera au cadre législatif. Le domaine de la santé inclut la pratique médicale, ainsi que les services d'urgence médicale, les soins à domicile et l'assistance des personnes handicapées dans leur vie de tous les jours (c'est-à-dire l'Assistance à l'Autonomie à Domicile, Ambient Assisted Living en anglais).
General Information
- Standard12 pagesEnglish and French languagesale 15% off
- Draft8 pagesEnglish languagesale 15% off
ISO/TR 17791:2013 provides guidance to National Member Bodies (NMBs) and readers by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software. The framework presented in ISO/TR 17991:2013, together with the mapping of standards to the framework, illustrate relevant standards and how they can optimally be applied. The mapping works to clearly demonstrate where standards gaps and overlaps exist. Specifically, ISO/TR 17791:2013: identifies a coherent set of international standards that promote the patient-safe (or safer) development, implementation and use of health software, provides guidance on the applicability of these standards towards enabling optimal safety in health software within overall risk management and quality management approaches, as well as within the lifecycle steps and processes of health software development, addresses the health software safety issues that remain, either as gaps or overlaps between or among the identified standards, and discusses how those gaps and overlaps could be addressed?in the short or long term?through revision of the current standards or the development of new ones. Harm to the operators of health software, should any such risk exist, is outside the scope of ISO/TR 17791:2013.
- Technical report47 pagesEnglish languagesale 15% off
Frequently Asked Questions
IEC/TC 62 is a Technical Committee within the International Organization for Standardization (ISO). It is named "Electrical equipment in medical practice" and is responsible for: To prepare international standards and other publications concerning electrical equipment, electrical systems and software used in healthcare and their effects on patients, operators, other persons and the environment. NOTE : This scope includes items that are also within the scopes of other committees and will be addressed through cooperation. Attention will focus on safety and performance (e.g. radiation protection, data security, data integrity, data privacy and environmental aspects) and will contribute to regulatory frameworks. Healthcare includes medical practice as well as emergency medical services, homecare, and support of persons with disabilities in their daily lives (i.e. Ambient Assisted Living). This committee has published 410 standards.
IEC/TC 62 develops ISO standards in the area of Information technology. The scope of work includes: To prepare international standards and other publications concerning electrical equipment, electrical systems and software used in healthcare and their effects on patients, operators, other persons and the environment. NOTE : This scope includes items that are also within the scopes of other committees and will be addressed through cooperation. Attention will focus on safety and performance (e.g. radiation protection, data security, data integrity, data privacy and environmental aspects) and will contribute to regulatory frameworks. Healthcare includes medical practice as well as emergency medical services, homecare, and support of persons with disabilities in their daily lives (i.e. Ambient Assisted Living). Currently, there are 410 published standards from this technical committee.
The International Organization for Standardization (ISO) is an independent, non-governmental international organization that develops and publishes international standards. Founded in 1947 and headquartered in Geneva, Switzerland, ISO brings together experts from 170+ member countries to share knowledge and develop voluntary, consensus-based standards that support innovation and provide solutions to global challenges.
A Technical Committee (TC) in ISO is a group of experts responsible for developing international standards in a specific technical area. TCs are composed of national member body delegates and work through consensus to create standards that meet global industry needs. Each TC may have subcommittees (SCs) and working groups (WGs) for specialized topics.