201.1 Scope, object and related standards

IEC 60601-1:2005+Amendment 1:2012, Clause 1 applies, except as follows:

201.1.1 Scope

IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by:

This particular standard specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories , hereafter referred to as me equipment , intended to increase the oxygen concentration of gas intended to be delivered to a single patient . Such oxygen concentrators are typically intended for use in the home healthcare environment , including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft.

NOTE 1 Such an oxygen concentrator can also be used in professional healthcare facilities.

This particular s...

BS EN ISO 80601-2-69:2014 PDF

Abstract

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