AS IEC 60601.1.9:2017 pdf free
AS IEC 60601.1.9:2017 pdf free.Medical electrical equipment
set of PROCESSES that transforms requirements into specified characteristics or into the specification of a product, PROCESS or system
NOTE 1 The terms“design” and “development” are sometimes used synonymously and sometimes used to define different stages of the overall PROCESS of turning an idea into a product.
NOTE 2 Product development is the PROCESS of taking a product idea from planning to market launch and post-market review of the product, in which business strategies, marketing considerations, research methods and design aspects are used to take a product to a point of practical use. It includes improvements or modifications to existing products or PROCESSES
NOTE 3 The integration of ENVIRONMENTAL ASPECTS into product DESIGN AND DEVELOPMENT can also be termed design for the ENVIRONMENT (DFE), eco-design, the environmental part of product stewardship, etc.[ISO/TR 14062:2002, definition 3.3]
The MANUFACTURER shall establish and document targets for the significant ENVIRONMENTAL ASPECTS of the ME EQUIPMENT to minimize as far as reasonable the adverse ENVIRONMENTAL IMPACTS across all LIFE-CYCLE stages. The documented targets shall be based on functional as well as environmental requirements, and, when available, previous product designs.
During the ME EQUIPMENT concept and specification setting stage, the MANUFACTURER shall consider, as far as reasonable, novel emerging or alternative technologies and/or solutions for the ME EQUIPMENT that reduce significant adverse ENVIRONMENTAL IMPACTS.
The MANUFACTURER shall assess and document the actual significant ENVIRONMENTAL ASPECTS across all LIFE-CYCLE stages of a representative prototype of the final design of the ME EQUIPMENT. Any deviations from the targets shall be assessed and documented for consideration in future designs.
In the future, MANUFACTURERS and RESPONSIBLE ORGANIZATIONS will be required to holistically meet enhanced environmental criteria and to further improve product quality and safety.ME 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. ME EQUIPMENT should be designed,manufactured, used and discarded in a manner that is environmentally responsible.AS IEC 60601.1.9 pdf free download.
