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Class Number Description
8750-01
MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS - Medical Equipment/ Medical System

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COVERAGE:

Medical electrical equipment 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.

REQUIREMENTS as per the following applicable standards:

CSA-C22.2 No. 601.1 S1-94 Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90 – Medical
Electrical Equipment – Part 1: General Requirements for Safety adopted
IEC 601-1 2nd edition (90), amendment 1 (91).
CSA-C22.2 No. 601.1.3-98 Medical Electrical Equipment – Part 1-3: General requirements for
safety. Collateral standard General Requirements for Radiation
Protection in Diagnostic X-ray Equipment adopted IEC 601-1-3 (94)
CSA-C22.2 No. 601.1B-90 Amendment 2 to CAN/CSA-C22.2 601.1-M90 Medical Electrical Equipment
– Part 1: General requirements for Safety adopted IEC 601-1 2nd edition,
amendment 2 (95).
CSA-C22.2 No. 601.1-M90 Medical Electrical Equipment – Part 1: General Requirements for
Safety adopted IEC 601-1 2nd edition (90)
CSA-C22.2 No. 601.2.10-92 Medical Electrical Equipment – Part 2-10: Particular requirements
for the safety of Nerve and Muscle Stimulators adopted IEC 60601-2-10
Corrigendum (02).
CSA-C22.2 No. 601.2.10A-92 Amendment 1: 2004 to CAN/CSA-C22.2 60601-2-10-92 Medical Electrical
Equipment – Part 2-10: Particular requirements for the safety of Nerve
and Muscle Stimulators adopted IEC 60601-2-10 Corrigendum (02).
CSA-C22.2 No. 601.2.19-92 Medical Electrical Equipment – Part 2-19: Particular requirements
for the safety of Baby Incubators adopted IEC 601-2-19 (90)
CSA-C22.2 No. 601.2.19A-92 Amendment 1: 2001 to CAN/CSA-C22.2 601.2.19-92 Medical Electrical
Equipment – Part 2-19: Particular requirements for the safety of Baby
Incubators adopted IEC 601-2-19 (90)
CSA-C22.2 No. 601.2.20-92 Medical Electrical Equipment – Part 2-20: Particular requirements
for the safety of Transport Incubators adopted IEC 601-2-20 (90)
CSA-C22.2 No. 601.2.20A-92 Amendment 1: 2001 to CAN/CSA-C22.2 601.2.20-92 Medical Electrical
Equipment – Part 2-20: Particular requirements for the safety of
Transport Incubators adopted am1 IEC 601-2-20 (96)
CSA-C22.2 No. 601.2.21-98 Medical Electrical Equipment – Part 2-21: Particular requirements
for the safety of Infant Radiant Warmers adopted IEC 601-2-21 (94)
CSA-C22.2 No. 601.2.21A-98 Amendment 1: 2001 to CAN/CSA-C22.2 601.2.21-98 Medical Electrical
Equipment – Part 2-21: Particular requirements for the safety of Infant
Radiant Warmers adopted am1 IEC 601-2-21 (96)
CSA-C22.2 No. 601.2.25-94 Medical Electrical Equipment – Part 2-25: Particular requirements
for safety of Electrocardiographs, adopted IEC 60601-2-25 (93)
CSA-C22.2 No. 601.2.25A-94 Amendment 1: 2002 to CAN/CSA-C22.2 60601-2-25-94 Medical Electrical
Equipment – Part 2-25: Particular requirements for safety of
Electrocardiographs, adopted IEC 60601-2-25 Am.1 (99)
CSA-C22.2 No. 601.2.28-94 Medical Electrical Equipment – Part 2-28: Particular requirements
for the safety of X-ray Source Assemblies and X-ray Tube Assemblies for
Medical Diagnosis adopted IEC 601-2-28 (93)
CSA-C22.2 No. 601.2.31-98 Medical Electrical Equipment – Part 2-31: Particular requirements
for the safety of External Cardiac Pacemakers with Internal Power Source
adopted IEC 601-2-31 (94)
CSA-C22.2 No. 601.2.31A-98 Amendment 1: 2001 to CAN/CSA-C22.2 601.2.31-98 Medical Electrical
Equipment – Part 2-31: Particular requirements for the safety of
External Cardiac Pacemakers with Internal Power Source adopted am1 IEC
601-2-31 (98)
CSA-C22.2 No. 601.2.3-92 Medical Electrical Equipment – Part 2-3: Particular requirements for
the safety of Short-Wave Therapy Equipment adopted IEC 601-2-3(91)
CSA-C22.2 No. 601.2.3A-92 Amendment 1: 2001 to CAN/CSA-C22.2 601.2.3-92 Medical Electrical
Equipment – Part 2-3: Particular requirements for the safety of
Short-Wave Therapy Equipment adopted Am 1 to IEC 601-2-3(98)
CSA-C22.2 No. 601.2.6-92 Medical Electrical Equipment – Part 2-6: Particular requirements for
the safety of Microwave Therapy Equipment adopted IEC 601-2-6 (84).
CSA-C22.2 No. 60601-1-1-02 Medical Electrical Equipment – Part 1-1: General requirements for
Safety -Collateral Standard Safety Requirements for Medical Electrical
Systems adopted IEC 60601-1 2nd ed. (01)
CSA-C22.2 No. 60601-1-2-03 Medical Electrical Equipment – Part 1-2: General requirements for
safety. Collateral standard Electromagnetic Compatibility – Requirements
and Tests adopted IEC 60601-1-2: (01), A1 (04)
CSA-C22.2 No. 60601-1-2A-05 Medical Electrical Equipment – Part 1-2: General requirements for
safety. Collateral standard Electromagnetic Compatibility – Requirements
and Tests adopted am 1 to IEC 60601-1-2 (06)
CSA-C22.2 No. 60601-1-4-02 Medical Electrical Equipment – Part 1-4: General requirements for
safety. Collateral standard Programmable Electrical Medical Systems
adopted IEC 60601-1-4 (00)
CSA-C22.2 No. 60601-1-6-05 Medical Electrical Equipment – Part 1-6: General requirements for
safety. Collateral standard Usability adopted IEC 60601-1-6 (04)
CSA-C22.2 No. 60601-1-8-05 Medical Electrical Equipment – Part 1-8: General requirements for
safety. Collateral standard Test and Guidance for Alarm systems in
electrical medical equipment and electrical medical systems adopted IEC
60601-1-8 (03)
CSA-C22.2 No. 60601-2-1-01 Medical Electrical Equipment – Part 2-1: Particular requirements for
the safety of Electron Accelerators in the Range 1 MeV to 50 MeV adopted
IEC 60601-1-2 Ed.2 (98)
CSA-C22.2 No. 60601-2-11-01 Medical Electrical Equipment – Part 2-11: Particular requirements
for the safety of Gamma Beam Therapy Equipment adopted IEC 60601-1-11 Ed
2 (97).
CSA-C22.2 No. 60601-2-11A-05 Amendment 1: 2005 to CAN/CSA-C22.2 60601-2-11-01 Medical Electrical
Equipment – Part 2-11: Particular requirements for the safety of Gamma
Beam Therapy Equipment adopted am 1 to IEC 60601-1-11 Ed 2. (97), am1
(04)
CSA-C22.2 No. 60601-2-12-03 Medical Electrical Equipment – Part 2-13: Particular requirements
for the safety of Lung Ventilators for Medical Use adopted IEC
60601-2-12 Ed 2 (03)
CSA-C22.2 No. 60601-2-13-07 Medical Electrical Equipment – Part 2-13: Particular requirements
for the safety of Anaesthetic Systems adopted IEC 60601-2-13:2003 Ed.3
(03), am 1:2006.
CSA-C22.2 No. 60601-2-16-01 Medical Electrical Equipment – Part 2-16: Particular Requirements
for Safety of Haemodialysis, Haemodiafiltration and Haemofiltration
Equipment adopted IEC 60601-1-16 Ed 2. (98).
CSA-C22.2 No. 60601-2-17-04 Medical Electrical Equipment – Part 2-17: Particular requirements
for the safety of Remote-Controlled Automatically-Driven Gamma-ray After
loading Equipment adopted 60601-2-17, Ed.2 (04)
CSA-C22.2 No. 60601-2-18-01 Medical Electrical Equipment – Part 2-18: Particular requirements
for the safety of Endoscopic Equipment adopted IEC 60601-2-18 Ed. 2
(96).
CSA-C22.2 No. 60601-2-18A-01 Amendment 1: 2002 to CAN/CSA-C22.2 60601-2-18-01 Medical Electrical
Equipment – Part 2-18: Particular requirements for the safety of Medical
Electrical Equipment of Endoscopic Equipment adopted IEC 60601-2-18 Am1
to Ed. 2 (00).
CSA-C22.2 No. 60601-2-1A-01 Amendment 1: 2003 to CAN/CSA-C22.2 60601-2-1-01 Medical Electrical
Equipment – Part 2-1: Particular requirements for the safety of Electron
Accelerators in the Range 1 MeV to 50 MeV adopted IEC 60601-1-2 AM1
(02).
CSA-C22.2 No. 60601-2-2:08 Medical Electrical Equipment – Part 2-2: Particular requirements for
the safety of high frequency surgical equipment adopted IEC 60601-2-2
(06) Ed.4
CSA-C22.2 No. 60601-2-2-01 Medical Electrical Equipment – Part 2-2: Particular requirements for
the safety of High Frequency Surgical Equipment adopted IEC 60601-2-2
Ed. 3 (98)
CSA-C22.2 No. 60601-2-22-01 Medical Electrical Equipment – Part 2-22: Particular requirements
for the safety of Diagnostic and Therapeutic Laser Equipment adopted IEC
60601-2-22 Ed. 2 (95)
CSA-C22.2 No. 60601-2-23-02 Medical Electrical Equipment – Part 2-23: Particular requirements
for the safety including essential performance Transcutaneous Partial
Pressure Monitoring Equipment adopted IEC 60601-2-23 2ed (99)
CSA-C22.2 No. 60601-2-24-01 Medical Electrical Equipment – Part 2-24: Particular requirements
for the safety of Infusion Pumps and Controllers adopted IEC 60601-2-24
(98).
CSA-C22.2 No. 60601-2-26-04 Medical Electrical Equipment – Part 2-26: Particular requirements
for the safety of Electroencephalographs, adopted IEC 60601-2-26 Ed.2
(02).
CSA-C22.2 No. 60601-2-27- Medical Electrical Equipment – Part 2-27:
Particular requirements for the safety of Electrocardiographic
Monitoring Equipment adopted IEC 60601-2-27(05)
CSA-C22.2 No. 60601-2-29-02 Medical Electrical Equipment – Part 2-29: Particular requirements
for the safety of Radiotherapy Simulators adopted IEC 60601-2-29 2ed
(99)
CSA-C22.2 No. 60601-2-30-02 Medical Electrical Equipment – Part 2-30: Particular requirements
for the safety of Automatic Cycling Indirect Blood Pressure Monitoring
Equipment adopted IEC 60601-2-30, Ed.2 (99).
CSA-C22.2 No. 60601-2-32-98 Medical Electrical Equipment – Part 2-32: Particular requirements
for the safety of Associated Equipment of X-ray Equipment adopted IEC
60601-2-32(94).
CSA-C22.2 No. 60601-2-33-04 Medical Electrical Equipment – Part 2-33: Particular requirements
for the safety of Magnetic Resonance Equipment for Medical Diagnosis
adopted IEC 60601-2-33, Ed.2 (02)+ am1(05)
CSA-C22.2 No. 60601-2-33B-04 Medical Electrical Equipment – Part 2-33: Particular requirements
for the safety of Magnetic Resonance Equipment for Medical Diagnosis
adopted IEC 60601-2-33, Ed.2 (02)+ am2(08)
CSA-C22.2 No. 60601-2-34-02 Medical Electrical Equipment – Part 2-34: Particular requirements
for the safety of Direct Blood Pressure Monitoring Equipment adopted IEC
60601-2-34 Ed 2 (00)
CSA-C22.2 No. 60601-2-36-98 Medical Electrical Equipment – Part 2-36: Particular requirements
for the safety of Extracorporeally Induced Lithotripsy Adopted IEC
60601-2-36 (97).
CSA-C22.2 No. 60601-2-37-03 Medical Electrical Equipment – Part 2-37: Particular requirements
for the safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
adopted IEC 60601-2-37 (01).
CSA-C22.2 No. 60601-2-37A-03 Amendment 1: 2005 to CAN/CSA-C22.2 60601-2-37-03 Medical Electrical
Equipment – Part 2-37: Particular requirements for the safety of
Ultrasonic Medical Diagnostic and Monitoring Equipment adopted am 1 to
IEC 60601-2-37 (01), am1 (04)
CSA-C22.2 No. 60601-2-38-03 Medical Electrical Equipment – Part 2-38: Particular requirements
for the safety of Electrically Operated Hospital Beds adopted IEC
60601-2-38(96) including Am.1 (99).
CSA-C22.2 No. 60601-2-39-02 Medical Electrical Equipment – Part 2-39: Particular requirements
for the safety of Peritoneal Dialysis Equipment adopted IEC 60601-2-39
(03)
CSA-C22.2 No. 60601-2-40-01 Medical Electrical Equipment – Part 2-40: Particular requirements
for the safety of Electromyographs and Evoked Response Equipment adopted
IEC 60601-2-40 (98).
CSA-C22.2 No. 60601-2-4-04 Medical Electrical Equipment – Part 2-4: Particular requirements for
the safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors
adopted IEC 60601-2-4 Ed.2 (02).
CSA-C22.2 No. 60601-2-41-02 Medical Electrical Equipment – Part 2-41: Particular requirements
for the safety of Surgical Luminaires and Luminaires for Diagnosis
adopted IEC 60601-2-41 (00)
CSA-C22.2 No. 60601-2-43-03 Medical Electrical Equipment – Part 2-43: Particular requirements
for the safety of X-ray Equipment for Interventional Procedures adopted
IEC 60601-2-43 (00).
CSA-C22.2 No. 60601-2-44-03 Medical Electrical Equipment – Part 2-44: Particular requirements
for the safety of X-ray Equipment for Computed Tomography adopted IEC
60601-2-44 (01)
CSA-C22.2 No. 60601-2-44A-04 Amendment 1: 2001 to CAN/CSA-C22.2 60601-2-44-03 Medical Electrical
Equipment – Part 2-44: Particular requirements for the safety of X-ray
Equipment for Computed Tomography adopted am 1 to IEC 60601-2-44 (01),
Am.1 (02).
CSA-C22.2 No. 60601-2-45-02 Medical Electrical Equipment – Part 2-45: Particular requirements
for the safety of Mammographic X-ray Equipment and Mammographic
Stereotactic Devices Adopted IEC 60601-2-45 Ed 2. (01)
CSA-C22.2 No. 60601-2-46-01 Medical Electrical Equipment – Part 2-46: Particular requirements
for the safety of Operating Tables adopted IEC 60601-2-46 (98).
CSA-C22.2 No. 60601-2-47-03 Medical Electrical Equipment – Part 2-47: Particular requirements
for the safety of Essential performance of ambulatory
Electrocardiographic systems adopted IEC 60601-2-47 (01).
CSA-C22.2 No. 60601-2-49-04 Medical Electrical Equipment – Part 2-49: Particular requirements
for the safety of Multi-parameter Patient Monitoring Equipment adopted
IEC 60601-2-49 (01).
CSA-C22.2 No. 60601-2-50-03 Medical Electrical Equipment – Part 2-50: Particular requirements
for the safety of Infant Phototherapy Equipment adopted IEC 60601-2-50
(00).
CSA-C22.2 No. 60601-2-5-02 Medical Electrical Equipment – Part 2-5: Particular requirements for
the safety of Ultrasonic Physiotherapy Equipment adopted IEC 60601-2-5
(00)
CSA-C22.2 No. 60601-2-51-04 Medical Electrical Equipment – Part 2-51: Particular requirements
for the safety of Recording and analyzing single and Multi-channel
electrocardiographs adopted IEC 60601-2-51 (03).
CSA-C22.2 No. 60601-2-7-01 Medical Electrical Equipment – Part 2-7: Particular requirements for
the safety of High Voltage Generators of diagnostic X-ray generators
adopted IEC 60601-2-7 Ed.2 (98).
CSA-C22.2 No. 60601-2-8-01 Medical Electrical Equipment – Part 2-8: Particular requirements for
the safety of Therapeutic X-Ray equipment operating in the range 10KV to
1MV Adopted IEC 60601-2-8 Ed.1.1 (99).
CSA-C22.2 No. 60601-2-9-01 Medical Electrical Equipment – Part 2-9: Particular requirements for
the safety of Patient Contact Dosimeters used in Radiotherapy with
Electrically Connected Radiation Detectors Ed. 2 (10/96).
CSA-Z10535-03 Hoist for the Transfer of Disabled Persons – Requirements and Test
Methods, Adopted ISO 10535:1998 with Canadian deviations.

Note:  Evaluations shall include relevant Collateral and Part 2
standards as applicable.

The above Standards may also require the use of associated Bulletins, Notices
and/or Supplements due, for example, to new requirements becoming effective
after publication of the Standards.

The Certified component appearing in this classification is judged to comply
with the applicable requirements of the Canadian Electrical Code (CEC).

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
exists.

The above Standard may also require the use of applicable supplements and
amendments.

MARKINGS:

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 over-current 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

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:


  1. The equipment has not been investigated for the protection against
    hazards of explosions in medically used rooms.
  2. Units provided without Canadian Certified power supply cord set are
    certified as a component.
  3. 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).

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