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ISO/TS 11633-1:2026

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

CDN $261.00

This publication was last reviewed and confirmed in 2026.

Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis

SKU: ae3fc460d4f1 Categories: ,

Description

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.

Edition

2

Published Date

2026-09-16

Status

PUBLISHED

Pages

19

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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.

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