DIN EN ISO 16671:2024-10
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671.2:2024); German and English version prEN ISO 16671:2024 / Note: Date of issue 2024-08-30
| Fecha de anulación: |
2026-03-01
Anulada
|
|---|---|
| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer. This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function. |
| Keywords: | Aqueous dispersions|Clinical investigations|Construction details|Data of the manufacturer|Definitions|Implants (surgical)|Irrigating solutions|Marking|Medical equipment|Medical products|Ophthalmic equipment|Ophthalmic optics|Ophthalmology|Optics|Packages|Particles|pH|Safety|Specification (approval)|Sterilization (hygiene)|Surgery|Surgical equipment|Surgical implants |
| ICS: | 11.040.70 - Equipo oftálmico |
| CTN: | |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 16671:2024-01 Es reemplazada por DIN EN ISO 16671:2026-03 |
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