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Electrical Safety Testing for Medical Device

If you are looking for Electrical safety testing for Medical Device, ITCIndia can help you!

ITC India Pvt Ltd is accredited laboratory to test Medical equipments as per IEC 60601-1. The test procedure followed by the laboratory is mentioned in this article. All the testing is done with the highly accurate and calibrated machines. Even qualified engineers are appointed to do the testing of medical products. Safety testing is required at the point of manufacturing of the equipment and before its launch.  Safety testing ensures that no hazardous voltage or current are accessible to the user.

First of all we must know why we do safety testing of electrical equipments?

The answer is for the safety of the operator as well as to block harm to patient and staff. Identifying, correcting and eliminating shock hazards is the motive of electrical safety testing.

Most of current, voltage and frequencies give harm to the operators, patients and staff.  Now, let us discuss about these factors in details.

We would like to consider the frequency first; Low frequency a.c signals accidentally used to human tissues can cause somatic sensation, muscles cramp or even death. Sensitivity is very much dependent on frequency which should be restricted to a maximum of 60 Hz.

Another factor is the patient skin resistance, whenever the resistance decreases, smaller voltage can result in higher and higher current and hence can injure patient. [The resistance of human body decreases due to illness]. Dry and healthy skin has a resistance of 60kΩ to 100 kΩ.

Effect of current on human body:

S.No Current Reaction
1 Less than 1mA Generally not recognizable
2 1mA Faint tingle
3 5mA Injuries
4 6-25 mA Painful shock, loss of muscular control
5 50 – 150 mA Extreme pain, respiratory arrest, death possible
6 1000-4300mA Muscular contraction and nerve damage , death likely
7 10,000mA Cardiac Arrest, serve burns , even death

 

Patient contact with leads, catheters, etc. from medical instrumentation reduces skin’s resistance. All of these devices have direct patient contact and can be a conduit for dangerous low frequency a.c. signals. e.g.  EKG leads, „ Catheters inserted into the body, „ Probes, „ ESU devices, „ Defib paddles, „ Physical therapy equipment. Keeping all in mind many kinds of current are studied by the standards.

  1. Chassis source current
  2. Ground current
  3. Lead current
  4. Isolation test

The test Plan of IEC 60601-1

S. No. Clause No. Title of test
1 4.1-4.10 General Requirements
2 4.11 Power input
3 8.4.2 Protection against
accidental contact
4 8.7 Leakage Current & Patient Auxiliary current
5 8.7.4.5 Earth Leakage Current
6 8.7.4.6 Enclosure leakage
Current
7 8.7.4.7 Patient Leakage Current
8 8.7.4.8 Patient Auxiliary Current
9 8.8.3 Dielectric Strength Test
10 a. Insulation Resistance
Test
11 5.7 Humidity preconditioning treatment
12 7 Identification, Marking and Documents.
13 8.4.3 Voltage Drop test
14 8.4.4 Internal capacitive circuits
15 8.5.2.1 F-TYPE APPLIED PARTS/ TYPE B APPLIED PARTS
16 8.7.4, LEAKAGE CURRENT tests
17 8.8.3 Dielectric
strength test
18 8.9 Creepage Distance and Air Clearance
19 8.9.3.4 Thermal cycling
20 8.5.5.2 Energy reduction test
21 8.6.4 Impedance and current-carrying capability
22 8.8.4 Insulation other than wire insulation
23 11.6 Resistance to moisture,
24 8.8.3 Dielectric strength
25 15.3 Mechanical strength
26 8.8.4.1 Ball-pressure test
27 8.9.1.7 Material groups classification
28 Comparative tracking index (CTI)
29 8.11.3.5 Cord anchorage Pull Test
30 8.11.3.6/
15.4.1
Cord guards
31 8.11.4.2 MAINS TERMINAL Bent Test
32 9.4.2.2 Stability Test
33 9.8.3.2 Static forces
34 9.8.3.3 Dynamic forces due to loading from persons
35 11 Protection against excessive temperatures
36 11.6.2 Overflow in ME EQUIPMENT/ Dielectric Strength/ Leakage Current Test
37 11.6.3 Spillage on ME EQUIPMENT, Dielectric Strength/ Leakage Current Test
38 12 Accuracy of controls and instruments and protection against hazardous
outputs
39 13.1.2 limit power
dissipation
40 13.2 SINGLE FAULT CONDITIONS
41  15.3 Mechanical strength
42 15.3.2 Push test
43 15.3.3 Impact test
44 15.3.4 Drop test
 45 15.3.5 Rough handling test
46 a. Ascending step shock
47 b. Descending step shock
48 c. Door frame shock
49 15.3.6 Mould stress relief test
50 15.4.6.1 Rotating controls torque test
51 15.4.7.3 Foot-operated control devices(IP Testing)
 52 15.5 MAINS SUPPLY TRANSFORMERS
53 15.5.1.2 Short-circuit test
54 15.5.2 Dielectric strength

 

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