British Standards Institution

Source:: IEC
Committee:: CH/62/1 - Common aspects of medical equipment, software, and systems
Categories:: Information management | Standardization. General rules | Healthcare | Medical equipment | ICT | Information technology | IT applications. Health care technology

Scope

This document provides practical methods to help achieve BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to the possible effects of ELECTROMAGNETIC DISTURBANCES throughout the EXPECTED SERVICE LIFE of an ME EQUIPMENT or ME SYSTEM.

These practical methods attempt to address all of the different types of errors, malfunctions or failures that can be caused by ELECTROMAGNETIC DISTURBANCES in ME EQUIPMENT or ME SYSTEMS that use modern digital technologies (i.e. hardware and software)

Purpose

The purpose of this document is to provide recommendations for the techniques and measures used in the design, VERIFICATION, and validation of systems, hardware, and software (firmware) used in ME EQUIPMENT or ME SYSTEMS to help achieve BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to the ELECTROMAGNETIC DISTURBANCES that could occur throughout the EXPECTED SERVICE LIFE.

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Please email further comments to: debbie.stead@bsigroup.com

Standard timeline

1. Proposal

Proposal start date:

01/12/2022

Proposal end date:

17/01/2023

2. Draft

3. Public Comments

4. Comment Resolution

5. Approval

6. Publication

Learn more about the standards development process

Standards Development

IEC 62A/1498/NP Guidance and interpretation – Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances

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