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BSI - 23/30464123 DC

Draft BS ISO 18190 Anaesthetic and respiratory equipment - General requirements for airway devices and related equipment

pending
Organization: BSI
Publication Date: 11 August 2023
Status: pending
Page Count: 25
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10

Document History

23/30464123 DC
August 11, 2023
Draft BS ISO 18190 Anaesthetic and respiratory equipment - General requirements for airway devices and related equipment
A description is not available for this item.
BS ISO 18190
October 31, 2016
Anaesthetic and respiratory equipment — General requirements for airways and related equipment
A description is not available for this item.

References

This document references:
EN 15986 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Published by CEN on March 1, 2011
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive...
This document references:
IEC 60601-1-2 - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Published by IEC on September 1, 2020
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 60601-1-6 - 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 60601-1-8 - 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
Published by IEC on July 1, 2020
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 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...
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