Reference details
- Reference
- EN ISO 7711-1:1998/A1:2009
- Official title
- Dental rotary instruments - Diamond instruments - Part 1: Dimensions, requirements, marking and packaging - Amendment 1 (ISO 7711-1:1997/Amd 1:2009)
- Organisation
- CEN
- Publisher status in source
- WithdrawnThis is the status recorded in the source, not a statement that this is the latest edition.
- Source access
- 19 October 2026
Research and application
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Product research routes
- Medical devices
Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls.
- Measurement, test and laboratory equipment
Measurement function, accuracy claims, electrical safety and the conditions under which results are comparable.
- Packaging, logistics and handling equipment
Protection, transport conditions, package systems and equipment interfaces throughout distribution.
Questions for the evidence file
- Intended purpose
- Classification rationale
- Risk management
- Verification and performance evidence
- Clinical evidence scope
- Measurement model
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Legal citation
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