There’s a new Amendment 1 for IEC 60601-1-9, “Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design.” This collateral standard was developed to improve the environmental impact for the entire range of medical electrical equipment, taking into account all stages of the product life cycle.
The 10-page Amendment 1 for the Edition 1.0 has been issued to update the references to IEC 60601-1, since there has been a recent amendment 1 for that document as well (IEC 60601-1 Amendment 1 dated 2012). At the same time, the committee took advantage of the opportunity to make a few minor editorial changes.
You’ll find pen-and-ink changes for IEC 60601-1-9 Section 1.3.1, Section 2 (Normative references), Section 3 (Terms and definitions), and Annex A (Section A.2, Clause 1). The text includes these updates in both English and French, so the Amendment can be used for all editions in force.
The changes have also been interfiled into the IEC 60601-1-9 itself, so you can purchase a new interfiled Edition 1.1, which contains the new language entirely. This can have an advantage in that you’ll know that any staff member will be using the correct information going forward.
Consideration of the environmental affects of medical devices early in the cycle can produce numerous benefits. These might include lower costs, stimulation of innovation and creativity, and increased knowledge about the product. IEC also believes environmental planning can provide new business opportunities and improved product quality, as well as reduce adverse environmental impacts. This is an emerging science, so the committee anticipates that IEC 60601-1-9 will require periodic review as the science develops.
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