IEC 62353

Introduction
Specially formulated for in house and routine electrical safety testing of medical equipment at hospitals Introduced by mid of 2007

IEC 62353 doesn't need special laboratory conditions

Safer for clinical and service engineers Formulated since routine testing doesn't need stringent testing as done by manufacturers

IEC 62353

Historical Perspective
1960-1970: Increase in adoption and use of biomedical instrumentation in hospitals

1970: Ralph Naders survey - 1200 patients in US were electrocuted

annually during routine diagnosis 1976: Adoption of standards pertaining to the design, manufacture and/or testing of medical devices IEC 60601 and IS13450 standards: Applies to safety of medical equipments

IEC 62353

Physiological Effects of Electricity

Muscle cramps Respiratory arrest

Cardiac arrest
Ventricular fibrillation Burns Electrolysis

IEC 62353

Electrical Safety: Patients Standpoint

Application of electric circuits directly to the human body for diagnosis and therapy Absence of normal protection to currents provided by the patient's

skin, if this is penetrated or treated to obtain a low skin resistance

Absence of normal reactions of the patient who may be ill, unconscious, anaesthetized, immobilized etc Support or replacement of vital body functions may depend on the reliability of the equipment

IEC 62353

IEC 62353 Standard Equipment Classification

According to the type of protection against electric shockPower Source

Class I

Equipment with exposed conductive parts connected to the protective earth in the fixed wiring of the installation

Class II
Internally Powered

Equipment with additional protection to basic insulation, but having no direct connections to protective earth
Equipment is powered from battery

IEC 62353

IEC 62353 Standard Equipment Classification

According to the degree of protection against electric shockApplied Part

F- Type

Applied part which is electrically isolated from Earth and other parts of the medical equipment. i.e. floating

B- Type
BF- Type CF- Type

Applied parts, which are usually Earth referenced. Not suitable for direct cardiac application. e.g. Dental chair
Applied part complying with a higher degree of protection against electric shock than Type B applied parts. Not suitable for direct cardiac application. e.g. SPO2 Applied Part complying with the highest degree of protection against electric shock. Suitable for direct cardiac application. e.g. ECG monitor

IEC 62353

Tests Conducted

Visual Inspection Earthbond Testing

Insulation Measurements
Leakage Measurements

Equipment Leakage Applied Part Leakage

IEC 62353

Earthbond Testing

Tests the integrity of the low resistance connection between the earth conductor and any metal conductive part (Class I Equipment) Earth bond resistance should be less than 0.3 ohm Test voltage to be applied - less than 24V Test current to be applied - +/- 200 mA constant

IEC 62353

Insulation Resistance Measurement

This test is applicable to both CLASS I (earthed) and CLASS II (unearthed) equipments. During the measurement all switches of the MAINS PART shall be in operating position (ON). Insulation resistance measurements shall be performed with 500V (D.C.). Specifications Measurement : 1. EUT to Earth / Ground 2. AP to Ground Test voltage : 500V DC @1mA Safe limit : >100K

IEC 62353

Insulation Resistance Measurement

Insulation resistance shall be measured between:
A. B. C. D. E. Mains part and protective earth ( Class I only) Mains part and non-earthed accessible conductive parts Mains part and applied parts F-type applied part and protective earth ( Class I only) F-type applied part and nonearthed accessible conductive parts

IEC 62353

Leakage Tests

Equipment leakage Current flowing from the mains part to earth via the protective earth conductor, accessible conductive parts of the enclosure and applied parts Measured by three different methods Direct method, Alternative method and Differential method Applied part leakage Current flowing from main parts and the accessible conductive parts of the enclosure to the applied parts Measured by two different methods - Direct method and Alternative method

IEC 62353

Leakage Tests
a. Direct method
Measures true leakage that would occur whilst the medical equipment is in typical use, this will give highest accuracy on low leakage current measurement. The DUT will be powered ON from mains through the analyzer
Specifications Test Voltage Measuring Device : 230V, 50Hz : As per IEC 60601-1 requirements

b. Differential method
Measures the total leakage current and DUT does not need to be isolated during measurement. The DUT will be powered ON from mains through the analyzer and the measurement is taken as the difference between line and neutral currents
Specifications Test Voltage Measuring Device : 230V, 50Hz : As per IEC 60601-1 (1KOhm)

c. Alternative method
This test provide highest safety for person doing the test. Here the supply inputs of the DUT will be shoted and an equivalent voltage generated by the analyzer will be connected as prescribed in the standard
Specifications Test Voltage Measuring Device : 250V, 50Hz : As per IEC 60601-1 (1KOhm)

IEC 62353

Leakage Tests
Equipment leakage a a Applied part leakage

Internally Powered

IEC 62353

Leakage Current Limits

Current in A Type B Applied Part Type BF Type CF

Equipment Leakage current (Alternative method)

Class 1 Class 2 Equipment Leakage current ( Direct or Differential method) Class 1 Class 2 Applied part Leakage current (Alternative method) Applied part Leakage current ( Direct or Differential method) 500 100 500 100 50 50 500 100 50 50 1000 500 1000 500 1000 500

www.cdac.in

IEC 62353

Comparing IEC 62353 with IEC 60601

IEC 60601
Manufacturers type-test standard
Need special laboratory condition Stringent measurement parameters

IEC 62353
Routine and in house testing of equipment
No need of special laboratory condition Nominal measurement parameters suitable for routine testings

IEC 62353

CDAC-T and SCTIMST jointly developed Indias 1st indigenous medical electrical safety analyzer