Standards

This International standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems. If a clause or sub clause is specifically intended to be applicable to Me equipment only , or to ME systems only. the little and content of that clause will say so . It that is not the case, the clause or sub clause applies both to ME equipment and to ME systems as relevant.

This standard applies to the safety of medical electrical , electrical systems, as defined in 2.201. It describes the safety requirements necessary to provide protection for the patient, the operations and surroundings.

This standard applies to electromagnetic compatibility of medical electric equipment and medical electrical systems, hereinafter referred to as equipment and systems respectively.

This collateral standard applies to medical diagnostic equipment and to sub-assemblies of such equipment. The object of this collateral standard to establish general requirements for protection against ionizing radiation in medical diagnostic X-ray equipment , in order that the dose equivalent to the patient the operator and other staff can be kept as low as reasonably achievable.

This collateral standard applies to the safety of medical electrical equipment and medical electrical system incorporating programmable electrical subsystems (press ), hereinafter referred to as programmable electrical medical systems (PERMS).

This collateral standard specifies requirements for a process to analyses , design, verify and validate the usability , as it relates of medical electrical equipment , hereinafter referred to as equipment, This standard normal use and use errors but excludes abnormal use.

This collateral standard specifies requirements for alarm systems and alarm signals in medical electrical equipment and medical electrical systems.

This clause of the General standard applies except as follows : This particular standard specifies requirements for the safety , including essential performance, of recording and analyzing single channel and multichannel electrocardiographs as defined in 2, 101, 2, 111, 2, 117, 2,123, 2, 126, hereinafter referred to as equipment. The equipment may be attended or unattended.

This clause of part 1 is applicable except as follows : These particular requirements apply to electrical rang hood ( including their accessories and their component parts) for household and similar use. By similar use is understood the use in similar conditions as in households, for example in inns, coffee- houses, tea-rooms.

This standard is applicable to mains-powered or battery -powered information technology equipment, including electrical business equipment and associated equipment, with a rated voltage not exceeding 600 V.