Bionet Oxy9Wave Vet, Руководство по эксплуатации

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Oxy9Wave Vet
Operation manual
Ver. 1.52 1.SAFETY INFORMATION 6
1-1. CE Standard Information
▷ The following electromechanical safety standards have been met:
EN/IEC 60601-1 edition 3.0
Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
EN/IEC 60601-1-2 edition 4.0
Medical electrical equipment
— Part 1-2: General requirements for basic safety and essential performance
— Collateral standard: Electromagnetic compatibility
— Requirements and tests
EN/IEC 62304 edition 1.0
Medical device software – Software life-cycle processes
EN/IEC 60601-1-6 edition 3.0
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
EN/IEC 60601-1-8 edition 2.0
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
ISO 80601-2-61:2011 edition 1.0
Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and
essential performance of pulse oximeter equipment
ISO 10993-10:2010
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
ISO 10993-5:2009
Biological evaluation of medical vices -- Part 5: Tests for in vitro cytotoxicity
EN ISO 14971:2012
Medical devices - Application of risk management to medical devices
EN 980:2008
Symbols for use in the labeling of medical devices
ISO 15223-1:2012
Medical devices -- Symbols to be used with medical device labels, labeling and information to
be supplied -- Part 1: General requirements
MEDDEV 2.4/1 rev.9
Classification of medical devices(June 2010)
MEDDEV 2.7/1 rev.3
Clinical evaluation: Guide for manufacturers and notified bodies(December 2009)