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BSI - BS EN 82304-1

Health software Part 1: General requirements for product safety

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Organization: BSI
Publication Date: 31 March 2017
Status: active
Page Count: 34
ICS Code (IT applications in health care technology): 35.240.80

Document History

BS EN 82304-1
March 31, 2017
Health software Part 1: General requirements for product safety
A description is not available for this item.
BS IEC 82304-1
March 31, 2017
Health software Part 1: General requirements for product safety
A description is not available for this item.

References

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 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 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 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 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 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 is referenced by:
BS PD ISO/TS 20405 - Health informatics — Framework of event data and reporting definitions for the safety of health software
Published by BSI on May 31, 2018
A description is not available for this item.
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