and object Clause 1 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows: NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
* Scope Replacement: This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment
This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series
The object of this document is to establish particular basic safety and essential performance requirements for a high-frequency ventilator, as defined in 201.3.201, and its accessories. NOTE 1 Accessories are included because the combination of the high-frequency ventilator and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of a high-frequency ventilator. NOTE 2 This document has been prepared to address the relevant essential principles [39] and labelling [40] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC. NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex DD. NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 [38] as indicated in Annex FF.
| SDO | CSA: Canadian Standards Association |
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| Publication Date | Jan. 1, 2023 |
| Language | en - English |
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