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EN_cover.pdf 1 C075947e.pdf -1 201. 1 * Scope, object and related standards 9 201.1. 2 Object 10 201.1. 3 Collateral standards 10 201.1. 4 Particular standards 10 201. 2 Normative references 11 201. 3 Terms and definitions 12 201. 4 General requirements 15 201. 4.3 Essential performance 15 201. 4.3.101 * Additional requirements for essential performance 15 201. 4.6 * ME equipment or ME system parts that contact the patient 16 201. 5 General requirements for testing of ME equipment 16 201. 5.101 Additional requirements for general requirements for testing of ME equipment 16 201. 5.101.1 Gas flowrate and pressure specifications 16 201. 5.101.2 * Sleep apnoea breathing therapy equipment testing errors 16 201. 6 Classification of ME equipment and ME systems 16 201. 7 ME equipment identification, marking and documents 16 201. 7.1.2 * Legibility of markings 17 201. 7.2.4.101 Additional requirements for accessories 17 201. 7.2.13.101 Additional requirements for physiological effects 17 201. 7.2.17.101 * Additional requirements for protective packaging 17 201. 7.2.101 Additional requirements for marking on the outside of ME equipment or ME equipment parts 18 201. 7.4.3 Units of measurement

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