AS IEC 60601.1.9:2017 pdf free download – Medical electrical equipment
In the future, MANUFACTURERS and RESPONSIBLE ORGANIZATIONS will be required to holistically meet enhanced environmental criteria and to further improve product quality and safety. M E EQUIPMENT is intended to have beneficial effects on humans. However if the damage to the ENVIRONMENT caused by the ME EQUIPMENT outweighs the medical benefits, this is counter- productive to the intended function of the ME EQUIPMENT . M E EQUIPMENT should be designed, manufactured, used and discarded in a manner that is environmentally responsible. The objective of this collateral standard is to reduce the ENVIRONMENTAL IMPACTS of the ME EQUIPMENT taking into account all the ME EQUIPMENT LIFE – CYCLE stages. Benefits of implementing this collateral standard include, for example, the reduction of potential sources of HARM , HAZARDOUS SUBSTANCES and WASTE , and savings of natural resources, raw materials and energy. Benefits can be grouped into transportation reduction, cost reduction and a positive public perception of the MANUFACTURER as a good corporate citizen. L IFE – CYCLE ASSESSMENT is a tool that can be used to reduce the ENVIRONMENTAL IMPACT of ME EQUIPMENT . The principle and framework for LIFE – CYCLE ASSESSMENT is described in ISO 1 4040 [7]. M ANUFACTURERS undertaking LIFE – CYCLE ASSESSMENT will have to select or develop their own PROCESSES and assessment tools to achieve product-related environmental improvements.
The ENVIRONMENTAL IMPACTS of ME EQUIPMENT are largely determined during the DESIGN AND DEVELOPMENT stage. Therefore, in order to reduce the adverse ENVIRONMENTAL IMPACTS of the new ME EQUIPMENT :
– adverse ENVIRONMENTAL IMPACT reduction should be seen as starting at the identification of need and flowing throughout DESIGN AND DEVELOPMENT ;
– it is highly desirable to start the ENVIRONMENTAL ASPECT / IMPACT assessment as early as possible in product planning.
Typically the ME EQUIPMENT LIFE CYCLE includes the stages in Table A.1 . Table A.1 contains both environmental considerations and, where applicable, examples of ENVIRONMENTAL ASPECTS for each LIFE – CYCLE stage.
Environmental protection is not a subject that is covered in all engineering training.Consequently this rationale is more detailed than normal for a standard of this type.The following is one of many examples of the LIFE – CYCLE stages of ME EQUIPMENT .
An effective ENVIRONMENTAL ASPECT assessment PROCESS catalogues ME EQUIPMENT -related ENVIRONMENTAL ASPECTS as a first step. One must be able to identify those ENVIRONMENTAL ASPECTS that are most important and can have the greatest opportunities for improvement. For example, it is important to know which environmentally HAZARDOUS SUBSTANCES there are in ME EQUIPMENT . The World Health Organization (WHO) provides information on possible environmentally HAZARDOUS SUBSTANCES . There can be regulatory restrictions on the use of some HAZARDOUS SUBSTANCES in particular markets. For example, some types of batteries contain environmentally HAZARDOUS SUBSTANCES and their disposal is regulated in many countries.