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BSI - 23/30441465 DC

Draft BS EN ISO 80601-2-80 Medical electrical equipment Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

pending
Organization: BSI
Publication Date: 16 May 2023
Status: pending
Page Count: 128
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10

Document History

23/30441465 DC
May 16, 2023
Draft BS EN ISO 80601-2-80 Medical electrical equipment Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
A description is not available for this item.
BS ISO 80601-2-80
August 31, 2018
Medical electrical equipment Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
A description is not available for this item.
BS EN ISO 80601-2-80
August 31, 2018
Medical electrical equipment Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
A description is not available for this item.
BS EN ISO 80601-2-80
August 31, 2018
Medical electrical equipment Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
A description is not available for this item.

References

This document references:
IEC 61672-1 - Electroacoustics - Sound level meters - Part 1: Specifications
Published by IEC on September 1, 2013
This part of IEC 61672 gives electroacoustical performance specifications for three kinds of sound measuring instruments: a time-weighting sound level meter that measures exponential-time-weighted,...
This document references:
IEC 62570 - Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
Published by IEC on February 1, 2014
A description is not available for this item.
This document references:
81001-5-1 - Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle
Published by IEC on December 1, 2021
This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1[11] – taking the specific needs for HEALTH SOFTWARE...
This document references:
17664-1 - Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
Published by ISO on July 1, 2021
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that...
This document references:
IEC 60601-1-3 - Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
Published by IEC on January 1, 2021
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....
This document references:
IEC 60601-1-3 - Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
Published by IEC on January 1, 2021
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....
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