Electromagnetic compliance

Microbiology or Microbiological tests Electrical safety tests Electromagnetic Compliance tests Environmental safety tests. 

Regulatory requirements may apply to health, safety, environmental emissions, and electromagnetic compatibility and these often require accompanying certification of compliance. In cases where customers require suppliers to be certified to ISO/TS 16949 it imposes a regulatory requirement on the design process. 

If lEC 61508 compliance only is used, it cannot be confirmed that the device functions properly when implemented in the intended application. Reasons for this include improper electromagnetic compatibility (EMC), harmful airborne particulate, power line conditioning issues, plant s lack of design/operation/maintenance experience with the device, and hardware/software limitations as defined in the safety manual. Refer to Clause L.4 for additional issues relating to lEC 61508 compliance assessments. 

Two of many requirements of electronic-system packaging are to ensure that the corresponding equipments are in compliance with apphcable national and international electromagnetic compatibility (EMC)... 

In the Electromagnetic Compatibility Directive (EC 2004) a combination of products installed in a specific place for a specific purpose can be deemed a fixed installation and dierefore not require CE marking, however, the system must still meet the essential requirements of the EMC Directive, dierefore the building s responsible person must construct a Technical Assessment File to demonstrate compliance of the fixed installation with the directive. 

This is not strictly a second tier document as its originators do not claim compliance with lEC 61508. However it covers similar ground and is therefore included here. It applies to the safety and performance of medical and electrical equipment. It also applies to electromagnetic compatibility (EMC) of medical equipment. 

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