Scope and object IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows: 201.1.1 Scope Replacement: NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2. This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment
The object of this document is to establish basic safety and essential performance requirements for a ventilator, as defined in 201.3.306, and its accessories. Accessories are included because the combination of the ventilator and the accessories needs to be adequately safe. Accessories can have a significant impact on the basic safety or essential performance of a ventilator. NOTE 1 This document has been prepared to address the relevant essential principles[42] and labelling[43] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex CC. NOTE 2 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 3 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745.
| SDO | CSA: Canadian Standards Association |
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| Publication Date | Jan. 1, 2024 |
| Language | en - English |
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