AS IEC 60601.1.9:2017 Medical electrical equipment
ENVIRONMENTAL IMPACT reductions need only be made to the extent technically and economically feasible. MANUFACTURERS should endeavour to make ENVIRONMENTAL IMPACT improvements across all LIFE – CYCLE stages. It is acceptable for ME EQUIPMENT to have increased ENVIRONMENTAL IMPACTS provided that it can be justified by an impact / benefit analysis of ME EQUIPMENT performance or medical benefit. M ANUFACTURERS should set challenging targets. Significant reductions to product costs can be achieved (less is better and cheaper). A reappraisal of how a product functions, is produced, used and disposed of, can yield significant ENVIRONMENTAL IMPACT reductions as well as cost advantages.
Creative solutions to reduce adverse ENVIRONMENTAL IMPACTS should be considered as early in the project as possible. Consideration should be given to:
a) modifying / upgrading existing products;
b) novel technologies;
c) creative design solutions;
d) alternative material choice;
e) use of recycled materials;
f) use of recovered components or assemblies;
g) new production PROCESSES ;
h) alternative energy sources;
i) PACKAGING reduction;
j) reduction / elimination of consumables;
k) service and maintenance reduction;
l) extended durability;
m) REUSE / RECYCLING and material recovery at END OF LIFE .
There can be experimentation with different configurations so that the design solution with the optimum balance between product benefit, performance and ENVIRONMENTAL IMPACTS can be easily and cost effectively established. It is necessary for the MANUFACTURER to understand the environmental profile of its ME EQUIPMENT . It is inevitable that at some point trade-offs will need to be made between various ENVIRONMENTAL IMPACTS in order to arrive at the best compromise.
IEC Guide 1 1 4 [3] identifies three types of trade-offs:
– Trade-offs between different ENVIRONMENTAL ASPECTS ; for example, optimizing a product for weight reduction might negatively affect its recyclability. The comparison of potential ENVIRONMENTAL IMPACTS associated with each option can help decision-makers find the best solution.
– Trade-offs between environmental, economic and social benefits. These can be tangible (e.g. lower cost, WASTE reduction), intangible (e.g. convenience) and emotional (e.g. image). For example, making a product more robust increases the lifetime and, as a result, might benefit the ENVIRONMENT by reducing long-term resource use and WASTE , but might also increase initial costs. This can have social as well as economic effects.
– Trade-offs between environmental, technical and/or quality aspects; for example, design decision related to the use of a particular material might negatively affect the reliability and durability of a product, even though this produces environmental benefits.