NF EN ISO 15798

NF EN ISO 15798

March 2010
Standard Cancelled

Ophthalmic implants - Ophthalmic viscosurgical devices

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.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2010

Number of pages

25 p.

Reference

NF EN ISO 15798

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S94-751

Print number

1 - 18/03/2010

International kinship

ISO 15798:2010

European kinship

EN ISO 15798:2010
Sumary
Ophthalmic implants - Ophthalmic viscosurgical devices

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.

Replaced standards (1)
NF EN ISO 15798
August 2001
Standard Cancelled
Ophthalmic implants - Ophthalmic viscosurgical devices

La présente Norme internationale s'applique aux dispositifs ophtalmiques viscoélastiques (OVD), une catégorie d'implants chirurgicaux non actifs présentant des propriétés de viscosité et/ou de viscoélasticité, destinés à une utilisation en chirurgie dans le segment antérieur de l'oeil humain. Les OVD sont conçus pour créer et maintenir de l'espace, pour protéger les tissus intraoculaires et manipuler les tissus en cours de chirurgie. Les OVD ne sont pas conçus pour avoir un effet pharmacologique. La présente Norme internationale définit les exigences, en matière de sécurité pour l'utilisation prévue, de conception, d'évaluation préclinique et clinique, de stérilisation, de conditionnement, d'étiquetage du produit et d'informations fournies par le fabricant.

Standard replaced by (1)
NF EN ISO 15798
November 2013
Standard Cancelled
Ophthalmic implants - Ophthalmic viscosurgical devices

ISO 15798:2013 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 15798:2013 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.

Table of contents
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Performances attendues
    4
  • 5 Données de conception
    4
  • 5.1 Généralités
    4
  • 5.2 Caractérisation des composants
    4
  • 5.3 Caractérisation du produit fini
    5
  • 6 Évaluation de la conception
    7
  • 6.1 Généralités
    7
  • 6.2 Évaluation de la sécurité biologique
    7
  • 6.3 Évaluation clinique
    8
  • 7 Stérilisation
    10
  • 8 Stabilité du produit
    11
  • 9 Intégrité et performance du système d'injection
    11
  • 10 Conditionnement
    11
  • 10.1 Protection contre l'endommagement au cours du stockage et du transport
    11
  • 10.2 Maintien de la stérilité durant le trajet
    11
  • 11 Informations à fournir par le fabricant
    11
  • Annexe A (normative) Essai d'implantation intraoculaire
    13
  • Annexe B (informative) Nombre de patients pour l'examen clinique de la pression intraoculaire
    16
  • Bibliographie
    17
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