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DIN EN ISO 16061:2010-01
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15); German version EN ISO 16061:2009 / Note: DIN EN 12011 (1998-03) remains valid alongside this standard until 2010-03-21.
| Fecha edición: |
2015-09-01
Anulada
|
|---|---|
| Fecha cancelación: | 2015-09-01 |
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. |
| Keywords: | Bearings|Biological hazards|Checks|Clinical|Composition|Connections|Construction details|Damage|Definitions|Design|Evaluations|General conditions|Implants (surgical)|Inactive|Instructions for use|Instruments|Marking|Materials|Measurement|Measuring techniques|Medical devices|Medical equipment|Medical products|Medical sciences|Non-active|Packages|Production|Protection|Selection|Specification (approval)|Sterile|Sterilization (hygiene)|Surgery|Surgical equipment|Surgical implants|Surgical instruments|Testing|Transport|Unsterile |
| ICS: | 11.040.30 - Instrumentos y materiales quirúrgicos |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 16061:2009 Idéntica ISO 16061:2008 |
|
Reemplazo Normas |
Reemplaza a DIN EN 12011:1998-03 Reemplaza a DIN EN ISO 16061:2007-12 Reemplaza a DIN EN ISO 16061:2009-05 Es reemplazada por DIN EN ISO 16061:2015-09 |










