NF EN ISO 7439

NF EN ISO 7439

May 2002
Standard Cancelled

Copper-bearing intra-uterine contraceptive devices - Requirements, tests

ISO 7439:2002 is applicable to single-use copper-bearing intra-uterine contraceptive devices and their insertion instruments. ISO 7439:2002 is not applicable to intra-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptive devices whose primary purpose is to release progestogens.Some aspects of ISO 7439:2002 are applicable to medicated intra-uterine devices and intra-uterine devices that do not contain copper.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2002

Number of pages

16 p.

Reference

NF EN ISO 7439

ICS Codes

11.200   Birth control. Mechanical contraceptives

Classification index

S97-032

Print number

1 - 07/12/2002

International kinship

ISO 7439:2002

European kinship

EN ISO 7439:2002
Sumary
Copper-bearing intra-uterine contraceptive devices - Requirements, tests

ISO 7439:2002 is applicable to single-use copper-bearing intra-uterine contraceptive devices and their insertion instruments.

ISO 7439:2002 is not applicable to intra-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptive devices whose primary purpose is to release progestogens.

Some aspects of ISO 7439:2002 are applicable to medicated intra-uterine devices and intra-uterine devices that do not contain copper.

Replaced standards (1)
NF S90-031
November 1985
Standard Cancelled
Medico-surgical equipment. Intra-uterine devices.

La présente norme définit les spécifications que doivent remplir les dispositifs intra-utérins livrés sous emballages individuels stériles, tant du point de vue du produit fini que des matières premières, ainsi que du fil de retrait et du système d'insertion. Elle donne également les méthodes d'essais permettant de vérifier que ces spécifications sont bien remplies. Elle spécifie d'autre part les conditions d'emballage, d'étiquetage et de stockage de ces produits.

Standard replaced by (1)
NF EN ISO 7439
September 2009
Standard Cancelled
Copper-bearing intra-uterine contraceptive devices - Requirements, tests

ISO 7439:2002 is applicable to single-use copper-bearing intra-uterine contraceptive devices and their insertion instruments. ISO 7439:2002 is not applicable to intra-uterine contraceptive devices consisting only of a plastics body and intra-uterine contraceptive devices whose primary purpose is to release progestogens. Some aspects of ISO 7439:2002 are applicable to medicated intra-uterine devices and intra-uterine devices that do not contain copper.

Table of contents
  • Avant-propos
    3
  • Introduction
    4
  • 1
    Domaine d'application 4
  • 2
    Références normatives 4
  • 3
    Termes et définitions 4
  • 4
    Performance prévue 5
  • 4.1
    Généralités 5
  • 4.2
    Performance clinique 5
  • 5
    Caractéristiques relatives à la conception 5
  • 5.1
    Généralités 5
  • 5.2
    Forme 5
  • 5.3
    Dimensions 6
  • 5.4
    Force de traction 6
  • 5.5
    Stabilité 6
  • 5.6
    Propriété visco-élastique 6
  • 5.7
    Détection in situ 6
  • 6
    Matériaux 7
  • 7
    Évaluation de la conception 7
  • 7.1
    Généralités 7
  • 7.2
    Détermination des dimensions 7
  • 7.3
    Détermination de la force de traction 7
  • 7.4
    Essai de propriété visco-élastique (essai de mémoire) 8
  • 7.5
    Dosage du sulfate de baryum et identification du baryum et du sulfate 8
  • 7.6
    Évaluation préclinique 9
  • 7.7
    Évaluation clinique 9
  • 8
    Fabrication et contrôle 10
  • 9
    Stérilisation 10
  • 10
    Emballage 10
  • 11
    Informations fournies par le fabricant 10
  • 11.1 Généralités
    10
  • 11.2 Étiquetage de l'emballage primaire
    10
  • 11.3 Étiquetage de l'emballage secondaire
    11
  • 11.4 Instructions d'utilisation
    11
  • 11.5 Instructions d'utilisation pour le patient
    12
  • Annexe ZA (informative) Articles de la présente norme européenne concernant les exigences essentielles ou d'autres dispositions des Directives EU
    13
  • Bibliographie
    14
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