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BSI - 19/30390556 DC

Draft BS EN 62304 Health software - Software life cycle processes

pending
Organization: BSI
Publication Date: 24 January 2019
Status: pending
Page Count: 96
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Software): 35.080
ICS Code (Medical equipment): 11.040
ICS Code (Medical equipment in general): 11.040.01

Document History

19/30390556 DC
January 24, 2019
Draft BS EN 62304 Health software - Software life cycle processes
A description is not available for this item.
18/30344861 DC
March 14, 2018
Draft BS EN 62304 Health software - Software life cycle processes.
A description is not available for this item.
BS EN 62304
November 30, 2006
Medical device software - Software life-cycle processes
A description is not available for this item.
BS EN 62304
November 30, 2006
Medical device software Software life-cycle processes
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...
BS EN 62304
November 30, 2006
Medical device software - Software life-cycle processes
A description is not available for this item.

References

This document references:
IEC 60601-1-6 - Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
Published by IEC on July 1, 2020
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
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 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
Published by IEC on January 1, 2017
Equipment included in scope This group safety publication is primarily intended to be used as a product safety standard for the products mentioned in the scope, but shall also be used by technical...
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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