IEC 60601-1-9 compliance requirements
IEC 60601-1-9 is not a ‘tick box’ prescriptive list of EcoDesign specifications. Instead, the standard requires medical device manufacturers to demonstrate how they have integrated EcoDesign principles into the product design and development process to minimize the significant environmental impacts of the product across its life cycle stages.
At first glance, the clause requirements in Section 4 of the IEC 60601-1-9 standard appear quite straightforward, particularly to companies who are familiar with ISO 14001 Environmental Management Systems.
| Clause | Requirement |
|---|---|
| 4.1 | Identify the environmental aspects of the new product design across all of the product’s life cycle stages |
| 4.2 | Determine which of these environmental aspects can have significant environmental impacts across the product’s life cycle stages. These are identified as significant environmental aspects. |
| 4.3 | Gather information during the concept and design stage from suppliers whose products and services are likely to contribute significant environmental aspects to the final product. |
| 4.4 | Set targets for the significant environmental aspects to minimise as far as reasonable the product’s significant environmental impacts across all life cycle stages. The design concept and specification setting stages shall consider novel, emerging or alternative technologies and/or solutions that can reduce the product’s significant environmental impacts. |
| 4.4 | Assess the actual significant aspects of a representative prototype across all life cycle stages. Any deviations from the targets shall be assessed and documented for consideration in future designs. |
| 4.5.1 | Make available information on the type and mass of packaging materials |
| 4.5.2 | Provide instructions in user manuals for minimising the environmental impact of the product during normal use. |
| 4.5.3 | Provide information to end-users on proper disposal of the product at end of life, and provide information to waste treatment facilities for environmentally responsible management of the waste products |
The compliance assessment checks which are specified in the standard are based on verifying that procedures are in place and that there is document evidence of them being followed.
For further information, please contact Dr Aidan Turnbull
Head of WEEE, RoHS & EcoDesign on +44 (0)1225 748420
