DIN EN ISO 16061:2021-06
Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021); German version EN ISO 16061:2021
| Fecha edición: |
2021-06-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document 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 document 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 document gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer. This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. |
| Keywords: | 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: | |
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Equivalencia Internacional |
Idéntica EN ISO 16061:2021 Idéntica ISO 16061:2021 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 16061:2015-09 Reemplaza a DIN EN ISO 16061:2020-02 |
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