Information provided on the equipment and in the accompanying documents largely determines how a product will be evaluated to IEC 60601-1. Taking into consideration when experienced manufacturers submit products for evaluation, non-compliance with clause 7 is quite often the only criticism of the product. A “minor” change to markings or documentation can have a “major” effect on a product submittal, perhaps leading to extensive re-evaluation and/or re-testing.
Gain an understanding of the requirements of Clause 7 for markings, which address durability and legibility, markings on the outside of the equipment, markings on the inside of the equipment, markings of controls, safety signs, symbols, color of insulation, and indicator lights and controls.
This module is included in the Designing for Compliance to IEC 60601-1 3rd Ed. eLearning bundle. Click here to access the full bundle.
Upon completion of this course, you should be able to:
- Locate marking requirements within IEC 60601
- Match general symbols and safety signs with their definitions
- Differentiate the acceptable colors of insulation, indicators and controls
- Identify what is required for inclusion in instructions for use and technical description
- Provide examples of information provided in accompanying documents
Learning objectives will be measured by knowledge check questions throughout and a final case study.
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