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NEN-EN-IEC 60601-1-8/A2

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

active, Most Current
Organization: NEN
Publication Date: 1 July 2021
Status: active
Page Count: 70
ICS Code (Medical equipment in general): 11.040.01

Document History

NEN-EN-IEC 60601-1-8/A2
July 1, 2021
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
A description is not available for this item.
NEN-EN-IEC 60601-1-8/A11
March 1, 2017
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
A description is not available for this item.
NEN-EN-IEC 60601-1-8/A1
April 1, 2013
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
A description is not available for this item.
NEN-EN-IEC 60601-1-8/C11
March 1, 2010
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
A description is not available for this item.
NEN-EN-IEC 60601-1-8
September 1, 2007
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
NEN-EN-IEC 60601-1-8/A1
June 1, 2006
Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
A description is not available for this item.
NEN-EN-IEC 60601-1-8
March 1, 2004
Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and in medical electrical systems
The object of this collateral standard is to specify basic safety and essential performance requirements and tests for alarm systems in medical electrical application. This is accomplished by...
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References

This document references:
AAMI TIR66 - Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
Published by AAMI on January 1, 2017
This document is intended to define the nomenclature, ingredients, and principles for the development, annotation and use of physiologic waveform databases for developing and testing the performance...
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 60601-1 - MEDICAL ELECTRICAL EQUIPMENT – Part 1: General requirements for basic safety and essential performance
Published by IEC on March 1, 2021
A description is not available for this item.
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 TR 80001-2-5 - Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance on distributed alarm systems
Published by IEC on December 1, 2014
This part of IEC 80001, which is a technical report, gives guidance and practical techniques for RESPONSIBLE ORGANIZATIONS, MEDICAL DEVICE manufacturers and providers of other information technology...
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