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BSI - 18/30344861 DC

Draft BS EN 62304 Health software - Software life cycle processes.

pending
Organization: BSI
Publication Date: 14 March 2018
Status: pending
Page Count: 106
ICS Code (IT applications in health care technology): 35.240.80
ICS Code (Medical equipment): 11.040

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:
AAMI TIR57 - Technical Information Report: Principles for medical device security—Risk management
Published by AAMI on January 1, 2016
This TIR provides guidance for addressing information security within the risk management framework defined by ANSI/AAMI/ISO 14971. This guidance is intended to assist manufacturers and other users...
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 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 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...
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