Standards Compliance and IEC Classification
Puritan Bennett 540™ Ventilator User’s Manual
A-17
A.10 Standards Compliance and IEC Classification
General Standards
•
Medical Electrical Equipment: General Requirements for Safety IEC60601-1 1990 and all its
amends up to 1996.
•
The ventilator will be constructed to comply with the following product Classifications as
detailed in Clause 5 of 60601-1:
•
Class II Equipment
•
Internally Powered Equipment
•
Type BF Applied Parts
•
IP31 with respect with respect to access to hazardous parts and ingress of moisture
•
Not suitable for use in the presence of flammable anesthetic mixtures
•
Not suitable for sterilization
•
Suitable for continuous operation
•
Detachable power supply cord
•
Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90 - Medical Electrical Equipment - Part 1:
General Requirements for Safety.
•
UL 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety June 30,
2003.
Collateral Standards
•
Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral standard
Electro-Magnetic Compatibility requirements and tests IEC 60601-1-2 2007.
•
Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral standard:
Programmable Electrical Medical Systems IEC 60601-1-4 2000.
•
Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral standard:
Usability IEC 60601-1-6 2006.
•
General Requirements, tests and guidance for alarm systems in medical electrical equipment
and medical electrical systems IEC 60601-1-8 2004.
Particular Standards
•
Lung Ventilators for Medical Use- Particular Requirements for Basic Safety and Essential
Performance Part 2: Home Care Ventilators for Ventilator-Dependent Patient ISO10651-2 2004.
•
Standard Specification for Ventilators Intended for Use in Critical Care ASTM F 1100 1997.
WARNING
The use of accessories and cables other than those specified, with the exception of parts sold by
Puritan Bennett as replacements for internal components, may result in increased emissions or decreased
immunity of the ventilator.
Summary of Contents for Puritan Bennett 540
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