Arrow AutoCAT 2 Series Operating Manual page 253

A p p e n d i x : A p p l i c a b l e S t a n d a r d s
Appendix – Applicable Standards
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety
CSA C2.22 No. 601.1 - M90 Medical Electrical Equipment: General Requirements
for Safety
EC Medical Device Directive (MDD) 93/42/EEC
PB 296892 section a111.1.7 class 2 guidelines (ECRI) - Operating Ambient
PB 296892 section a111.1.7 class 2 guidelines (ECRI)- Storage Ambient
ISTA procedure 1B 2001 - Shipping
Mil std 810E Method 514 and RTCA/DO 160C Section 8 curve N -
Sinusoidal Vibration
Mil std 810E Method 514 and RTCA/DO 160C Section 8 curve N - Random Vibration
MIL-STD-810E, Fig 516.4-1 - Shock, operational
PB-296 892, section AIII.3.1 (ECRI) - Elevator Threshold
ISTA Proc. 1B and ASTM D1083 Par. 9.0 Methods B & C - Shipping Drop test
PB-296 892, section AIII.3.4 Shipping Tip over test (ECRI) - Shipping Tip over test
Fed-Std-101, Method 5019.1 Shipping Vibration - Shipping Vibration
MIL-STD-810E, Method 503.3 - Thermal Shock
MIL-STD-810E, Method 500.3 - Altitude operational
RTTE 1999/5/EC - "Radio Equipment and Telecommunications Terminal Equipment
(R & TTE-D) in the Mutual Recognition of their Conformity Application of Council
Directive: 89/336/EEC-EMC Directive & 73/23/EEC-LVD"
EN 60601-1-4 - "Medical electrical equipment-Part 1-4: General requirements for
safety-Collateral standard: Programmable electrical medical systems"
EN 60601-2-25 - "International standard medical electrical equipment-Part 2-25:
Particular requirements for the safety of electrocardiographs"
EN 60601-2-34 - "Particular requirements for safety, including essential performance,
of invasive blood pressure monitoring equipment"
1. Declaration of Conformity to Electromagnetic Compatibility Standard -
IEC 60601-1-2:2001-09 (with EN60601-2-25:1995 Deviations)
Equipment Type - Intra Aortic Balloon Pump (IABP)
Equipment Model - AutoCAT 2 Series
®
Equipment Classification - Classified as Group IIB device under the Medical Device
Directive (MDD) 93/42/EEC
Appendix: Applicable Standards
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