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ISO 18778

Respiratory equipment Infant monitors Particular requirements

active, Most Current
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Organization: ISO
Publication Date: 15 February 2005
Status: active
Page Count: 34
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10

Document History

18778
June 1, 2022
Respiratory equipment — Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its...
ISO 18778
February 15, 2005
Respiratory equipment Infant monitors Particular requirements
A description is not available for this item.

References

This document references:
ISO 16142-1 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non‐IVD medical devices and guidance on the selection of standards
Published by ISO on March 1, 2016
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical...
This document references:
ISO 16142-1 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non‐IVD medical devices and guidance on the selection of standards
Published by ISO on March 1, 2016
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical...
This document references:
ISO 20417 - Medical devices — Information to be supplied by the manufacturer
Published by ISO on April 1, 2021
NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the...
This document references:
ISO 9000 - Quality management systems — Fundamentals and vocabulary
Published by ISO on September 15, 2015
This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: — organizations seeking sustained success...
This document references:
ISO 80601-2-61 - Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Published by ISO on December 1, 2017
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for...
This document references:
7000 DATABASE SNAPSHOT - Graphical symbols for use on equipment - Registered symbols
Published by ISO on June 3, 2020
A description is not available for this item.
This document is referenced by:
AAMI 16142-1 - Medical devices-Recognized essential principles of safety and performance of medical devices-Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Published by AAMI on January 1, 2016
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical...
This document is referenced by:
BS ISO 16142-1 - TC - Tracked Changes (Redline) - Medical devices — Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Published by BSI on February 24, 2020
A description is not available for this item.
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