Norm

NEN-EN-ISO 15798:2008 Ontw. en

Oogheelkundige implantaten - Oogheelkundige viscochirurgische middelen

  • Deze norm is ingetrokken sinds 15-02-2010

25,62

Over deze norm

Status Ingetrokken
Aantal pagina's 23
Commissie Intra-oculaire lenzen en contactlenzen
Gepubliceerd op 01-09-2008
Taal Engels
This International Standard applies 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. This International Standard defines 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.

Details

ICS-code 11.040.70
Nederlandse titel Oogheelkundige implantaten - Oogheelkundige viscochirurgische middelen
Engelse titel Ophthalmic implants - Ophthalmic viscosurgical devices
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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