Estamos mejorando nuestra Tienda, Portal de clientes y Aenormas para ofrecerte una mejor experiencia.
Si detectas cualquier incidencia o necesitas ayuda durante el proceso de compra, puedes contactarnos a través del chat o escribirnos a normas@aenor.com.
Nuestro equipo estará encantado de ayudarte.
DIN EN ISO 16061:2015-09
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015
| Fecha edición: |
2021-06-01
Anulada
|
|---|---|
| Fecha cancelación: | 2021-06-01 |
| 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, materials, design evaluation, manufacture, sterilization, packaging and information 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|Packages|Production|Protection|Selection|Specification (approval)|Sterile|Sterilization (hygiene)|Storage|Surgery|Surgical equipment|Surgical implants|Surgical instruments|Testing|Transport |
| ICS: | 11.040.30 - Instrumentos y materiales quirúrgicos |
| CTN: | |
|
Equivalencia Internacional |
Idéntica EN ISO 16061:2015 Idéntica ISO 16061:2015 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 16061:2010-01 Reemplaza a DIN EN ISO 16061:2013-08 Es reemplazada por DIN EN ISO 16061:2021-06 |










