NF EN ISO 16672

NF EN ISO 16672

April 2003
Standard Cancelled

Ophthalmic implants - Ocular endotamponades

ISO 16672:2003 applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.With regard to the safety and efficacy of OEs, ISO 16672:2003 specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2003

Number of pages

22 p.

Reference

NF EN ISO 16672

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S94-753

Print number

1 - 13/06/2003

International kinship

ISO 16672:2003

European kinship

EN ISO 16672:2003
Sumary
Ophthalmic implants - Ocular endotamponades

ISO 16672:2003 applies to ocular endotamponades (OEs), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.

With regard to the safety and efficacy of OEs, ISO 16672:2003 specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

Standard replaced by (1)
NF EN ISO 16672
October 2015
Standard Cancelled
Ophthalmic implants - Ocular endotamponades

ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina. With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

Table of contents
  • Avant-propos
    iv
  • 1
    Domaine d'application 1
  • 2
    Références normatives 1
  • 3
    Termes et définitions 2
  • 4
    Performances attendues 3
  • 5
    Données de conception 3
  • 5.1
    Généralités 3
  • 5.2
    Contaminants chimiques et biologiques 3
  • 5.3
    Description chimique 3
  • 5.4
    Concentration des composants 4
  • 5.5
    Masse volumique 4
  • 5.6
    Expansion gazeuse 4
  • 5.7
    Tension d'interface 4
  • 5.8
    Viscosité cinématique 4
  • 5.9
    Distribution de la masse moléculaire 4
  • 5.10 Particules
    4
  • 5.11 Indice de réfraction
    4
  • 5.12 Transmission spectrale
    4
  • 5.13 Tension superficielle
    5
  • 5.14 Pression de vapeur
    5
  • 6
    Évaluation de la conception 5
  • 6.1
    Généralités 5
  • 6.2
    Évaluation de la sécurité biologique 5
  • 6.3
    Investigations cliniques 6
  • 7
    Stérilisation 6
  • 8
    Stabilité du produit 7
  • 9
    Intégrité et performance du système d'injection 7
  • 10
    Conditionnement 7
  • 10.1 Protection contre l'endommagement au cours du stockage et du transport
    7
  • 10.2 Maintien de la stérilité durant le trajet
    7
  • 11
    Informations fournies par le fabricant 8
  • Annexe A (normative) Essai d'implantation intraoculaire
    10
  • Annexe B (informative) Investigations cliniques
    11
  • Bibliographie
    14
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