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BSI - BS ISO 81001-1

Health software and health IT systems safety, effectiveness and security Part 1: Principles and concepts

active, Most Current
Organization: BSI
Publication Date: 31 May 2021
Status: active
Page Count: 70
ICS Code (IT applications in health care technology): 35.240.80

Document History

BS ISO 81001-1
May 31, 2021
Health software and health IT systems safety, effectiveness and security Part 1: Principles and concepts
A description is not available for this item.

References

This document references:
IEC 61907 - Communication network dependability engineering
Published by IEC on December 1, 2009
This International Standard gives guidance on dependability engineering of communication networks. It establishes a generic framework for network dependability performance, provides a process for...
This document references:
IEC 62304 - Medical device software – Software life cycle processes
Published by IEC on June 1, 2015
Purpose This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for...
This document references:
IEC 62366-1 - Medical devices – Part 1: Application of usability engineering to medical devices
Published by IEC on June 1, 2020
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...
This document references:
IEC 80001-1 - Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
Published by IEC on October 1, 2010
Recognizing that MEDICAL DEVICES are incorporated into IT-NETWORKS to achieve desirable benefits (for example, INTEROPERABILITY), this international standard defines the roles, responsibilities and...
This document references:
IEC 82304-1 - Health software - Part 1: General requirements for product safety
Published by IEC on October 1, 2016
Purpose This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS designed to operate on general computing platforms and intended to be placed on the market without dedicated...
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