Safety Requirements
■ Categorization
− 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 applied part
− 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
− 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
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