Medical electrical equipment - Particular requirements for basic safety and essential performance of oxygen concentrator equipment
Medical electrical equipment - Particular requirements for basic safety and essential performance of oxygen concentrator equipment
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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...
Упомянутые в описании и другие стандарты BS