DIN EN ISO 16671:2026-03
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2025); German version EN ISO 16671:2025
| Fecha edición: |
2026-03-01
En Vigor
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|---|---|
| Idiomas disponibles: | Alemán |
| 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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Equivalencia Internacional |
Idéntica EN ISO 16671:2025 Idéntica ISO 16671:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 16671:2018-03 Reemplaza a DIN EN ISO 16671:2024-10 |
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