ENVIRON best practice compliance procedures
Although the clause requirements in Section 4 of the IEC 60601-1-9 standard appear quite straightforward, in practice it takes considerable EcoDesign experience and good design planning to ensure the practical integration of these requirements into the New Product Design process. For example:
- In practice many stages in the New Product Design process are iterative and build on the results from previous stages. This approach is also important for EcoDesign. For example, the identification of significant aspects and setting of EcoDesign targets should become progressively more detailed as the requirements specification is developed.
- Although identification of product environmental regulatory requirements is implicitly included within Clause 4.2, in practice this should be managed as a separate activity so that product regulatory requirements are addressed in the requirements specification and subsequently transferred into the design specification for action.
Structured series of checklists
ENVIRON's EcoDesign and Product Stewardship process and procedures address these points and integrate seamlessly into the company’s New Product Design process. The procedures comprise a structured series of checklists which are inserted into each stage of the New Product Design process. By completing the checklists the design team automatically generates the document evidence which is required to demonstrate compliance with IEC 60601-1-9.
The practical integration of ENVIRON's process and procedures into the New Product Design process has been tested by global medical device manufacturer Smiths Medical (www.smiths-medical.com). Smiths Medical has is planning to roll out ENVIRON's process and procedures across all sites world-wide
Global verification, testing and certification company SGS (www.sgs.com) has reviewed ENVIRON’s process and procedures and has confirmed that they are suitable for a company to use to gain certification to the IEC 60601-1-9 International Standard.
Training and ongoing support
To apply the processes and procedures engineers and designers will need training in EcoDesign principles and ongoing easy access to a wide range of detailed technical data to:
- understand detailed product environmental regulatory requirements
- design out restricted substances and select environmentally friendly materials and
- minimise the product's consumption of energy, water etc
- design for maintenance and recycling.
- minimise packaging and distribution impacts.
The EcoDesign Best Practice Club workshops and webinars and the interactive web database have been designed around the IEC 60601-1-9 best practice compliance procedures, specifically to meet this training requirement and provide ongoing support to the design team. The web database also provides an ideal mechanism to facilitate EcoDesign decisions which may require action from dispersed locations within a company and across its supply chains. For example, an OEM may have its head office and environmental regulatory functions in the US, product design team in Europe and manufacturing facilities in China.
For further information, please contact Dr Aidan Turnbull
Head of WEEE, RoHS & EcoDesign on +44 (0)1225 748420
