Cardiac Science Burdick 8500 Product Safety Manual page 38

Product Safety and Setup
Conforms to
Standards
Safety
Leakage current
Defibrillation
protection
Warranty
38
CAN/CSA-C22.2 No. 601.1-M90 (Medical Electrical Equipment
– Part 1: General Requirements for Safety)
CSA C22.2 No. 601.2.25 (Medical electrical equipment, Part 2:
Particular requirements for the safety of electrocardiographs)
UL 60601 (Medical Electrical Equipment, Part 1: General
Requirements for Safety)
EN 60601-1 1990/1988 +A1.A2 (Medical Electrical Equipment
– Part 1: General Requirements for Basic Safety and Essential
Performance)
EN 60601-2-25 & Amend. 1 (Medical electrical equipment, Part
2: Particular requirements for the safety of electrocardiographs)
EN 60601-1-2 (Medical Electrical Equipment – Part 1-2: General
Requirements for Safety – Collateral Standard: Electromagnetic
Compatibility – Requirements and Tests)
ANSI/AAMI EC53 (ECG cables and leadwires)
EN 60601-2-51 (Particular requirements for safety,
includingessential performance, of recording and analysing
single channel and multichannel electrocardiographs)
EN/ISO 10993-1 (Biological Evaluation of Medical Device – Part
1: Evaluation and Testing)
EN/ISO 10993-10 (Biological Evaluation Of Medical Devices -
Part 10: Tests For Irritation And Delayed-Type Hypersensitivity)
EN/ISO 13485 (Medical Devices – Quality Management
Systems – Requirements for Regulatory Purposes)
EN/ISO 14971 (Medical Devices – Application of Risk
Management to Medical Devices)
ISTA 1A (Package products 150 lbs (68 Kg) or less)
patient <10 μA, chassis <100 μA
to 5000V, 360J
8300—3 years with return of warranty card
8500—4 years with return of warranty card
70-01047-01 B