AS IEC 60601.1.9:2017 pdf free

09-07-2021 comment

AS IEC 60601.1.9:2017 pdf free.Medical electrical equipment Part 1.9: General requirements for basic safety and essential performance Collateral Standard: Requirements for environmentally conscious design.
4 Protection of the ENVIRONMENT
4.1 * Identification of ENVIRONMENTAL ASPECTS
THE MANUFACTURER shall establish, implement and maintain a PROCESS to identify and document the relevant ENVIRONMENTAL ASPECTS of ME EQUIPMENT across all LIFE-CYCLE stages.
— emissions to air;
— releases to surface water and ground water;
— use of natural resources, energy and raw materials;
— noise, vibration, odour, dust, electromagnetic fields etc.;
— transport (both for goods and services and employees);
— RISKS from environmental accidents and ENVIRONMENTAL IMPACTS arising, or likely to arise, as consequences of incidents, accidents and potential emergency situations; and
— use and contamination of the biosphere.
Compliance is checked by inspection of the relevant design documents and PROCESS description.
4.2 * Determination of significant ENVIRONMENTAL ASPECTS
The MANUFACTURER shall establish, implement and maintain a PROCESS to qualitatively or quantitatively determine and document the ENVIRONMENTAL ASPECTS that can have significant ENVIRONMENTAL IMPACTS (i.e. significant ENVIRONMENTAL ASPECTS) during all LIFE-CYCLE stages of the ME EQUIPMENT.
Compliance is checked by inspection of the relevant design documents and PROCESS
43 * Information from the SUPPLY CHAIN
The MANUFACTURER shall establish, implement and maintain PROCESSES to:
— identify those suppliers (including services) that are likely to contribute significant ENVIRONMENTAL ASPECTS to the ME EQUIPMENT; and
— obtain from those SUPPLIERS the information necessary to assist the MANUFACTURER in identifying and assessing the ENVIRONMENTAL ASPECTS of the ME EQUIPMENT as required in 4.1 and 4.2.
If. despite the MANUFACTURER’S efforts. ORGANIZATIONS within the SUPPLY CHAIN fail to provide the information requested by the MANUFACTURER, the MANUFACTURER shall provide an estimation of the missing information and document the rationale.
NOTE To fully assess the EN’.lRONMENTAL ASPECTS across the entire life of the ME EQUIPMENT it is necessary for the MANUFACTURER to gather information and involve the environmentally significant SUPPLIERS during the concept and design stage.AS IEC 60601.1.9 pdf download.

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