MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS - Certified to US Standards
Medical electrical equipment/system intended for use by or under the
supervision of qualified personnel in the patient environment, or related to the
patient in such a way that the safety of persons or animals in that environment
is directly affected. Transportation, storage, installation, use and maintenance
of such equipment are also specified.
|UL 2601-1||Medical Electrical Equipment – Part 1: General Requirements
|UL 60601-1||Medical Electrical Equipment – Part 1: General Requirements
Note: Where any of these Collateral and Particular Medical IEC 60601 series Standards
are not published by UL, then the corresponding IEC 60601 series Publications
will be used with the UL 60601-1 standard.
PARTICULAR STANDARDS (Part 2 standards) – contains requirements for safety which
are generally applicable to all medical electrical equipment. For certain types
of equipment, these requirements are to be supplemented or modified by the
special requirements of a Particular Standard. Where Particular Requirements
exist, the General Standard should not be used alone. Special care is required
in applying the General Standard to equipment for which no Particular Standard
The above Standards may also require the use of applicable supplements and
Equipment shall be plainly marked in a permanent manner in a place where the
details will be readily visible after installation with the following:
- submittor’s identification;
- model designation;
- complete electrical ratings; (in V, A, VA or W only if power factor is
greater than 0.9)
- required electrical rating of primary overcurrent protection;
- fuse ratings;
- classification symbols to indicate double insulation (where applicable),
type of moisture protection and degree of protection from electrical shock;
- date code or equivalent;
- installation instructions;
- CSA Mark with indicator "US"
Additional markings (caution or warning where applicable) and/or documentation
may be required for specific models and/or applications;
A CSA Accepted metallic adhesive label, a non-metallic self-adhesive label or as
hot stamping, permanent silk screening or equally permanent means.
PRODUCT MARKING (WITH RESPECT TO APPLICABLE STANDARDS): Equipment covered by
this standard may be subject to the requirements of standards other than the
General Standard indicated above. To enable those interested in determining the
standard to which the product has been evaluated, as part of the product marking
the reference to the General Standard must always be included. Reference to the
applicable Particular and/or Collateral Standards is to be made only if the
EQUIPMENT has been found to be in compliance with these standards.
Subject to the following conditions as applicable:
- The equipment has not been investigated for the protection against
hazards of explosions in medically used rooms
- Units provided without a United States of America Certified power supply
cord set are certified as a component.
- Evaluated to CAN/CSA C22.2 601.1 standards excluding requirements for
Electromagnetic compatibility (Clause 36), Biocompatibility (Clause 48) and
Programmable Electronic Systems (IEC 60601 1 4 referenced in sub clause 52.1).