MicroPace StimLab - Device Ratings, Classification, and Certification; Stimulator Classification and Standards

USER INSTRUCTION MANUAL
Page 6 of 49 ENGLISH
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2 DEVICE RATINGS, CLASSIFICATION AND
CERTIFICATION
CE Mark Compliance
The Micropace Cardiac Stimulator, is compliant with the following EEC directives:
 89/336/EEC & 92/31/EEC (EMC Directives)
 93/42/EEC & 2007/47/EEC (Medical Device Directive)
 93/68/EEC (CE Marking Directive)
Compliance Testing was carried out and coordinated by the following certified bodies:
 EMC Technologies, Castle Hill, Australia
 TCA - Testing and Certification Australia, Chatswood, Australia
The Micropace Cardiac Stimulator classification:
 TGA, Rule 4.3 Classification
Class IIb
 Medical Devices Directives (93/42/EEC, 2007/47/EEC & 93/68/EEC), Rule 10 classification:
Class IIb medical device
 IEC60601-1 electrical device classification:
Class II (mains-isolated by approved external isolation transformer), IPX0, Type CF
 FDA Medical Device Level of Concern
Level II
 Health Canada Medical Device Classification, Rule 10(2)
Class III
The Micropace Cardiac Stimulator system Power rating:
 220-240VAC 50-60Hz, 0.7A max / 110-120VAC 60Hz, 1.4A max
Identification of technical standards with which compliance is claimed
 ISO 13485 Quality management systems - Medical devices - System requirements for
regulatory purposes
 IEC60601-1:2005 Medical Equipment – Part 1: General requirements for safety.
 IEC60601-1-2:2007 Medical Equipment – Part 1: General requirements for safety. Collateral
Standard: Electromagnetic compatibility – Requirements and tests
Environmental Conditions
 Operating T° Range +5ºC to +35ºC (30% to 80% RH)
Issuing Notified
Body: BSI group.