NF EN ISO 16671

NF EN ISO 16671

November 2015
Standard Current

Ophthalmic implants - Irrigating solutions for ophthalmic surgery

ISO 16671:2015 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer. ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2015

Number of pages

32 p.

Reference

NF EN ISO 16671

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S94-752

Print number

1

International kinship

ISO 16671:2015

European kinship

EN ISO 16671:2015
Sumary
Ophthalmic implants - Irrigating solutions for ophthalmic surgery

ISO 16671:2015 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.

ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

Replaced standards (1)
NF EN ISO 16671
June 2004
Standard Cancelled
Ophthalmic implants - Irrigating solutions for ophthalmic surgery

<p>ISO 16671:2002 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.</p> <p>ISO 16671:2002 applies to ophthalmic irrigating solutions (OISs), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological or metabolic function.</p>

Table of contents
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  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Performances prévues
    2
  • 5 Attributs de conception
    2
  • 6 Évaluation de la conception
    5
  • 7 Stérilisation
    6
  • 8 Stabilité du produit
    7
  • 9 Emballage
    7
  • 10 Informations fournies par le fabricant
    7
  • Annexe A (informative) Exemple d'une méthode appropriée de mesure du pH et de détermination de la capacité tampon
    9
  • Annexe B (normative) Contamination particulaire: particules visibles
    10
  • Annexe C (informative) Méthode d'essai de mesure d'opacité pour la contamination particulaire: particules peu visibles
    11
  • Annexe D (informative) Méthode d'essai microscopique pour la contamination particulaire: particules peu visibles
    13
  • Annexe E (normative) Essai d'irrigation intra-oculaire
    18
  • Annexe F (informative) Investigations cliniques
    19
  • Bibliographie
    22
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