User's Manual

SIM™ User Manual | Ref Code: SUM | GEN4_0024| Version: 8
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1.6 STANDARDS AND COMPLIANCE AND IEC CLASSIFICATION
The SIM™ system was developed in accordance with pertinent North American and International standards.
The SIM™ pod with SIM™ sensor IEC 60601-1/EN 60601-1 classification is as follows:
Description
Specification
Model Number
6019
Mode of Operation
Continuous Operation
Protection against ingress of water
IP67
Applied Part
Type BF
Use in presence of flammable
anaesthetic mixtures
No
Suitable for Sterilisation
No
GENERAL STANDARDS – SIM™ POD AND SIM™ SENSOR
 Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance,
IEC/EN 60601-1 (2005/2006+C1+C2)
 Medical Electrical Equipment – Part 1: General Requirements for Safety, CSA C22.2 No 60601.1 (2008)
 Medical Electrical Equipment – Part 1: General Requirements for Safety, ANSI/AAMI ES60601-1
(2005+C1+A2)
 ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk
management process
COLLATERAL STANDARDS – SIM™ POD AND SIM™ SENSOR
 Medical Electrical Equipment – Part 1: General requirements for Safety - Collateral standard Electro-
Magnetic Compatibility requirements and tests IEC 60601-1-2 2010
 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance
– Collateral standard: Usability, IEC 60601-1-6:2010
 Medical Electrical Equipment – Part 1-11: General requirements for basic safety and essential performance
– Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment, IEC 60601-1-11:2010