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201. 1 Scope, object and related standards 11 201. 1.1 * Scope 11 201. 1.2 Object 12 201. 1.3 Collateral standards 13 201. 1.4 Particular standards 13 201. 2 Normative references 14 201. 3 Terms and definitions 17 201. 4 General requirements 19 201. 4.3 Essential performance 19 201. 4.3.101 * Additional requirements for essential performance 19 201. 4.4 Additional requirements for expected service life 19 201. 4.6 * ME equipment or ME system parts that contact the patient 20 201. 4.11.101 * Additional requirements for pressurized gas input 20 201. 4.11.101.1 Overpressure requirement 20 201. 4.11.101.2 Compatibility requirement 20 201. 5 General requirements for testing of ME equipment 21 201. 5.101 Additional requirements for general requirements for testing of ME equipment 21 201. 5.101.1 Ventilator test conditions 21 201. 5.101.2 * Gas flowrate and leakage specifications 21 201. 5.101.3 * Ventilator testing errors 21 201. 6 Classification of ME equipment and ME systems 22 201. 7 ME equipment identification, marking and documents 22 201. 7.2.3 * Consult accompanying documents 22 201. 7.2.4.101 Additional requirements for accessories 22 201. 7.2.13.101 Additional requirements for p

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Author

Dave Osborn

Language

EN

Category

reference