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:
- Those being the basic standard 60601-1 Medical Product Testing general demands for electrical medical equipment,
- 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),
- 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
- 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.