HRN EN ISO 15798:2010
Oftalmološki implantanti -- Oftalmološka viskoznokirurška sredstva (ISO 15798:2010; EN ISO 15798:2010)
| Oznaka: | HRN EN ISO 15798:2010 |
| Naslov (HR): | Oftalmološki implantanti -- Oftalmološka viskoznokirurška sredstva (ISO 15798:2010; EN ISO 15798:2010) |
| Naslov (EN): | Ophthalmic implants -- Ophthalmic viscosurgical devices (ISO 15798:2010; EN ISO 15798:2010) |
| Područje primjene (EN): | ISO 15798:2010 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery. ISO 15798:2010 specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices. |
| Izdanje: | 2 |
| ICS: | 11.040.70 Oftalmološka oprema |
| Tehnički odbor/pododbor: | TO 172, Optika i optički instrumenti |
| Oznaka faze: | 95.99 - povlačenje HRN |
| Glasilo (rasprava): | HZN Glasilo 4/2010 () |
| Glasilo (objava): | HZN Glasilo 5/2010 () |
| Glasilo (povlačenje): | 7/2013 () |
| Način prihvaćanja: | pr - prihvaćanje strane norme u izvorniku |
| Cijena #1: | Cijena: 35,00 € | Jezik: en | Cjenovni razred: F | Broj stranica: 22 |
| Izvornik: | EN ISO 15798:2010 |
| Zamjenjuje: | HRN EN ISO 15798:2008 |
| Zamjenjena s: | HRN EN ISO 15798:2013 |
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