Medical   -   Medical product Testing – 60601

IEC 60601 standard

Medical Product Testing IEC 60601 is a standard announced by the International Electrotechnical Commission. The standard be expressed by our parts, those being the base standard 60601-1 general requirements for electrical medical equipment, dependent standards counted 60601-1-x 60601-1-9, for instance, is a standard for environmental able to recognize Design of Medical Electrical Equipment, appropriate standards counted 60601-2-x kind of thing : Medical product Testing IEC 60601-2-2 is the standard for high frequency surgical devices, & performance standards in the 60601-3-x range.

The third edition of Medical product Testing IEC 60601-1 stand for a major inspection and repair of the IEC 60601 household of medical electrical equipment safety standards.First publicized in 1977.

Eurotech assesses product through testing against IEC 60601.

MEDICAL PRODUCT TESTING

  • Standards are fundamental part of product plan and transformation, and are basically essential in medical applications.
  • With the modern conversion to Medical product Testing IEC 60601-1 3rd version, specialists of medical equipment consider a range of new demands covering design methodological analysis and verification, safety and risk assessment, etc.

IEC 60601: Medical Product Testing

  • IEC 60601 Medical product Testing is a set special standards for the safety and effectivity of Medical Electrical Equipment.
  • This standard was published by International Electrotechnical Commission (IEC). 
  • It was first publicized in 1977 and regularly renewed & restructured. As of 2011 it exists of over 70 isolated standards. 
  • It is one of the indispensable standards to meet the demands of the Medical Device Directive for sales of Medical Devices in the European Union.

The standard consists of four parts:

  1. Those being the basic standard 60601-1 Medical Product Testing general demands for electrical medical equipment, 
  2. Collateral standards - These standards specify general requirements applicable to a subgroup of Medical Electrical Equipment. They are numbered 60601-1-x (60601-1-9, for example, is a standard for Environmentally Conscious Design of Medical Electrical (ME) Equipment), 
  3. Particular standards - These are standards that are specific to a particular device type.They are numbered 60601-2-x (example: IEC 60601-2-2 is the standard for high-frequency surgical devices), and 
  4. Performance standards in the Medical Product 60601-3-x range.


POINT OF USE:

  • This standard is generally used by the manufacturers, regulatory body, autonomous certification bodies and professional users and beneficiaries of medical electrical equipment. 
  • IEC 60601 employs to ME equipment and is to be used in the investigation, medication or supervision of a patient. It focuses on basic safety and essential performance of medical electrical equipment and systems.


IEC 60601-1 Evolution

  • IEC 60601 Medical standard has a past times with a number of revisions.
  • Originally IEC 60601-1 was first publicize in year 1977.
  • The second and third revision of the standard was printed in year 1988 and 2005 respectively.
  • The third edition of this medical safety standard was first published by the IEC in 2005 (IEC 60601-1:2005) and was adopted by the European Union in 2006 and published as EN60601-1:2006.

Complying with EN 60601-1

  • EN 60601-1 is applied to all Medical Electrical Equipment and Medical Electrical Systems.
  • Medical Electrical (ME) Equipment mainly represents an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient.
  • It is provided with not more than one connection to a particular SUPPLY MAINS.
 

© All Rights Reserved to EUROTECH