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 an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment
The object of this particular document is to establish basic safety and essential performance requirements for an EMS ventilator, as defined in 201.3.228, and its accessories. Accessories are included because the combination of the EMS ventilator and the accessories needs to have acceptable risk. Accessories can have a significant impact on the basic safety or essential performance of an EMS ventilator. NOTE 1 This document has been prepared to address the relevant essential principles[38] and labelling[39] 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 [40].
| SDO | CSA: Canadian Standards Association |
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| Publication Date | Jan. 1, 2024 |
| Language | en - English |
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