STN EN ISO 11980
| Name: | STN EN ISO 11980 |
| Validity: | Valid |
| Number of pages: | 44 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Očná optika. Kontaktné šošovky a prostriedky na ošetrovanie kontaktných šošoviek. Pokyny na klinické skúšky (ISO 11980: 2025) |
| English title | Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for clinical investigations (ISO 11980:2025) |
| Release Date: | 01. 10. 2025 |
| Date of withdrawal: | |
| ICS: | 11.040.70 |
| Sorting character/National clasification code | 19 5021 |
| Level of incorporation: | idt EN ISO 11980:2025, idt ISO 11980:2025 |
| Official Journal | 09/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 11980:2013-05 (19 5021) |
| Note in Official Journal: | |
| Subject of the standard: | This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products. NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document. NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP). |
| Preview: | Náhľad normy (PDF) |