Bistos BT-750, Руководство по эксплуатации

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BT-750 Operator Manual 62
P/N : OPM(BT-750)EN Bistos Co.,Ltd. Rev.02(2013.04.12)
14.5 List of Standards
OEN Reference Title of harmonized standard
Year of
ratification
Cenelec
EN 60601-1
Medical electrical equipment – Part 1:
General requirement for safety
1996
Cenelec EN 60601-1-1
Medical electrical equipment – Part 1-1:
General requirement for safety.
–Collateral Standard: Safety requirement for
medical electrical systems.
2001
Cenelec EN 60601-1-2
Medical electrical equipment – Part 1-2:
General Requirement for safety
– Collateral Standard : Electromagnetic
Compatibility Requirements and tests
2004
Cenelec EN 60601-1-4
Medical electrical equipment – Part 1-4 ,
General Requirement for safety – Collateral
Standard : Programmable electrical Medical
Systems
1999
Cenelec EN 60601-1-8
Medical electrical equipment – Part 1-8 ,
General Requirement for safety – Collateral
Standard : General Requirement tests and
guidance for alarm systems in Medical
electrical equipment and electrical Medical
Systems
2006
Cen EN 980
Graphical symbols for use in the labelling of
medical device
2008
Cen EN 1041
Specification for information supplied by
the Manufacturer of medical device
2008
Cen EN ISO 14971
Medical Devices – Application of risk
management to medical device
2007
Cen EN ISO 10993-1 Biological Evaluation of Medical Devices 2003
Cen EN ISO 9919
Medical electrical equipment-Particular
requirements for the basic safety and
essential performance of Pulse-Oximeters
equipment for medical use
2005
Cen EN ISO 14155-1
Clinical investigation of medical devices for
human subject- Part 1: General requirement
2003
Cen EN ISO 14155-2
Clinical investigation of medical devices for
human subject- Part 2: Clinical investigation
plans
2003
Cenelec EN 60601-2-27
Medical Electrical Equipment Part 2-27:
Particular Requiremen for the Safety,
including
essential performance,
Electrocardiographic Monitoring Equipment
2006
Cenelec
EN 60601-2-30
Medical electrical equipment — Part 2-30:
Particular requirements for the safety,
including
essential performance, of
automatic cycling non-invasive blood
pressure monitoring equipment.
2000