Chapter 1: Introduction
LS 06311-002US Rev A
13
1.5
Standards
The Sonata System has been tested to the following standards:
•
EN/IEC 60601-1, Medical Electrical Equipment: General Requirements for Safety and
Essential Performance.
•
EN/IEC 60601-1-2, Medical Electrical Equipment: General requirements for basic safety and
essential performance
–
Collateral standard: Electromagnetic compatibility
–
requirements
and tests.
•
EN/IEC 60601-1-6, Medical electrical equipment Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
•
EN/IEC 60601-1-8, 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.
•
EN/IEC 60601-2-2, Medical Electrical Equipment: Particular requirements for the basic safety
and essential performance of high frequency surgical equipment and high frequency surgical
accessories.
•
EN/IEC 60601-2-37, Medical Electrical Equipment: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment.
The Sonata System components are not anticipated to degrade in performance under normal use
within the expected use life of 5 years. As such, periodic maintenance inspections are not
mandatory. For provider facilities with Quality Assurance Programs that may require routine
inspections the following standards and guidance are recommended for service tests:
•
NFPA® 99
Health Care Facilities Code
•
NFPA 99
Health Care Facilities Code Handbook
•
IEC 62353
Recurrent test and test after repair of medical electrical equipment
•
ANSI/AAMI ES 60601-1; EN 60601-1