IECEE Guidance Document for ISO 14971 Risk Analysis - IEC EN 60601-1:2005 3rd edition

Marc

Fully vaccinated are you?
Leader
Re: IECEE Guidance Document for ISO 14971 Risk Analysis - IEC EN 60601-1:2005 3rd edi

For those of us following along:

IECEE: Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components

About the IECEE

In recognition of the need to facilitate international trade in electrical equipment, primarily intended for use in homes, offices, workshops, healthcare facilities and similar locations, for benefit of consumers, industries, authorities etc, and to provide convenience for manufacturers and other users of the services provided by various National Certification Bodies (NCBs), an international Scheme is operated by the IECEE (IEC System for Conformity testing and Certification of Electrotechnical Equipment and Components), known as the CB Scheme.

The Scheme is based on the principle of mutual recognition (reciprocal acceptance) by its members of test results for obtaining certification or approval at national level.

The Scheme is intended to reduce obstacles to international trade which arise from having to meet different national certification or approval criteria. Participation of the various NCBs within the Scheme is intended to facilitate certification or approval according to IEC standards.
 
J

Joerg_R

Re: IECEE Guidance Document for ISO 14971 Risk Analysis - IEC EN 60601-1:2005 3rd edi

Hay, many thanks for sharing the document. Our notified body aked to fill in the RM requirements to the TRF because they probalby didn't know how to do... No I can assist them. :)

Jörg
 
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