Texto para a Questão

Differences between IEC 60601-1 and IEC 62353 IEC 60601-1 is a type-testing standard describing the design criteria of ME EQUIPMENT which should be proven by applying a combination of stress and destructive tests. In addition, IEC 60601-1 specifies that these tests are carried out under certain environmental conditions. These laboratory conditions cannot be guaranteed whilst testing ME EQUIPMENT in-service. Therefore, measurements requiring certain environmental conditions can only be applied consistently with difficulty and are therefore not suitable for use during in-service testing of equipment. An additional aspect is that equipment could potentially be damaged during test applications and can face a potential danger to person(s) and surroundings.

Another aspect of the design process of ME EQUIPMENT is to ensure the safety of the equipment during its expected useful life. The selection of methods and materials should contribute in this way.

As far as possible, a consensus is required to harmonize the assessment of the safe operation and testing of ME EQUIPMENT and ME SYSTEMS whilst respecting local requirements and meeting increasing demands for risk management. It is therefore necessary to describe tests beyond those of the type testing and to provide a uniform and unambiguous means of assessing the equipment's safety whilst maintaining the relation to IEC 60601-1 and minimizing the risk of hazard to the person conducting the assessment.

All these aspects were considered during the creation of IEC 62353.

IEC 62353 primarily defines the requirements for ensuring the ELECTRICAL SAFETY of ME EQUIPMENT and ME SYSTEMS prior to PUTTING INTO SERVICE, during RECURRENT TESTING and after REPAIR whilst respecting the IEC 60601-1 design criteria and providing means of safer working practice to those persons involved in assessing the safety of ME EQUIPMENT and/or ME SYSTEMS.

In addition, IEC 62353 provides means to assess the aging process of ME EQUIPMENT and/or ME SYSTEMS through structured and regular INSPECTIONS.

A selection of test procedures, test methods and test intervals which can be used during the expected useful life of ME EQUIPMENT and ME SYSTEMS is described herein.

Fonte: IEC 62353:2014 - Medical electrical equipment — Recurrent test and test after repair of medical electrical equipment, BSI Standards Publication.

De acordo com o trecho retirado da IEC62353:2014, que apresenta as diferenças entre a mesma e a IEC60601, pode-se afirmar que: