70-01047-01 B
Product Safety and Setup
38
Conforms to
Standards
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
)
Safety
Leakage current
patient <10 μA, chassis <100 μA
Defibrillation
protection
to 5000V, 360J
Warranty
8300—3 years with return of warranty card
8500—4 years with return of warranty card
Содержание Burdick 8300
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