Technical Specification
ISO/TS 11633-1:2026
Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis
Reference number
ISO/TS 11633-1:2026
Edition 2
2026-09
© ISO 2026
Technical Specification

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Publicado (Edición 2, 2026)

ISO/TS 11633-1:2026

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Formato
CHF 135
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Resumen

This document specifies requirements and recommendations for remote maintenance services (RMSs) of medical devices and medical information systems in healthcare facilities (HCFs). This document is applicable to HCFs and remote service centres (RSCs) providing remote maintenance services for medical devices and medical information systems.

This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections.

This document provides practical examples of risk analysis to protect both the HCF and RMS provider information assets in a safe and efficient (i.e. economical) manner. These assets are primarily the information system itself and personal health data held in the information system.

Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2026-09
    Etapa
    : Norma Internacional publicada [60.60]
  • Edición
     : 2
    Número de páginas
     : 19
  • Comité Técnico :
    ISO/TC 215
    ICS :
    35.240.80 
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Esta norma contribuye al siguiente Objetivo de Desarrollo Sostenible

3
Good Health and Well-being

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  2. Tienda
  3. Tienda
  4. ICS
  5. 35
  6. 35.240
  7. 35.240.80
  8. ISO/TS 11633-1:2026