Safety Requirements
Classification
– Type of protection against electric shocks: Class I
– Degree of protection against electric shocks (when the patient is in physical contact):
Type BF or type CF mounting
– Degree of protection against the ingress of harmful liquids: General equipment
– Degree of safety of use in the presence of flammable anesthetic agent mixed with air,
oxygen, or nitrous oxide: Not suitable for use near flammable anesthetic agent mixed with
air, oxygen, or nitrous oxide
– Mode of operation: Continuous operation
Safety standards the device conforms to
– Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and
Essential Performance [IEC 60601-1:2005/ A1:2012]
– Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and
Essential Performance - Collateral Standard: Electromagnetic Compatibility –
Requirements and Tests [IEC 60601-1-2:2007]
– 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 2-37: Particular Requirements for the Basic Safety
and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
[IEC 60601-2-37:2007]
– Medical Electrical Equipment - Part 1: General Requirements for Safety [IEC 60601-
1:1988, A1:1991, A2:1995]
– Medical Electrical Equipment - Part 1-1: General Requirements for Safety – Collateral
Standards: General Requirements for Medical Electrical Systems [IEC 60601-1-1:2000]
– Medical Electrical Equipment - Part 1-2: General Requirements for Safety – Collateral
Standards: Electromagnetic Compatibility – Requirements and Tests [IEC 60601-1-
2:2001, A1:2004]
– Medical Electrical Equipment - Part 1-4: General Requirements for Safety – Collateral
Standards: Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999]
– Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety
and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment
[IEC 60601-2-37:2001, A1:2004, A2:2005]
– Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]
– Medical Electrical Equipment - Part 1: General Requirements for Safety [UL 60601-
1:2003]
– Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and
Essential Performance[CAN/CSA C22.2 No. 60601-1:14]
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