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Standards Development
This document gives guidelines for assisting organizations in establishing, documenting, implementing, maintaining and continually reducing the adverse environmental impact of their medical devices and related services through use of ecodesign.
This document is intended to be used by organizations that need help in integrating ecodesign into their management systems. The guidelines are applicable to all organizations in scope regardless of its type, size or product(s) provided.
This document is applicable to product-related environmental aspects and activities that an organization can control and those it can influence.
This document does not establish specific environmental performance criteria.
This standard provides guidance and criteria for reducing adverse environmental impacts, under the priority to maintain safety and effectiveness/performance of the medical device or medical device components. This includes aspects of the circular economy, e.g., take -back systems after end of service life, as a meaningful way to achieve the objective of this standard.
This standard provides a process aligned with the existing quality (ISO 9001 or ISO 13485) and environmental management (ISO 14001) and safety risk management (ISO 14971) standards and provides actionable criteria and measures to consider through informati ve annexes.
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