NF EN ISO 7439

NF EN ISO 7439

May 2012
Standard Cancelled

Copper-bearing contraceptive intrauterine devices - Requirements and tests

ISO 7439:2010 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. (Some aspects can be applicable to medicated intrauterine devices and IUDs not containing copper.)It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2012

Number of pages

19 p.

Reference

NF EN ISO 7439

ICS Codes

11.200   Birth control. Mechanical contraceptives

Classification index

S97-032

Print number

1 - 26/04/2012

International kinship

ISO 7439:2011

European kinship

EN ISO 7439:2011
Sumary
Copper-bearing contraceptive intrauterine devices - Requirements and tests

ISO 7439:2010 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. (Some aspects can be applicable to medicated intrauterine devices and IUDs not containing copper.)

It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

Replaced standards (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.

Standard replaced by (1)
NF EN ISO 7439
May 2015
Standard Cancelled
Copper-bearing contraceptive intrauterine devices - Requirements and tests

ISO 7439:2015 specifies requirements and tests for single-use, copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments. It is not applicable to IUDs consisting only of a plastics body or whose primary purpose is to release progestogens.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Performances prévues
    2
  • 4.1 Généralités
    2
  • 4.2 Performances cliniques
    2
  • 5 Caractéristiques relatives à la conception
    2
  • 5.1 Généralités
    2
  • 5.2 Forme
    2
  • 5.3 Dimensions
    2
  • 5.4 Force de traction
    3
  • 5.5 Stabilité
    3
  • 5.6 Propriété visco-élastique
    3
  • 5.7 Détection in situ
    3
  • 6 Matériaux
    4
  • 7 Évaluation de la conception
    4
  • 7.1 Généralités
    4
  • 7.2 Détermination des dimensions
    4
  • 7.3 Détermination de la force de traction
    4
  • 7.4 Essai de propriété visco-élastique (essai de mémoire)
    5
  • 7.5 Dosage du sulfate de baryum et identification du baryum et du sulfate
    6
  • 7.6 Évaluation pré-clinique
    6
  • 7.7 Évaluation clinique
    6
  • 8 Fabrication et contrôle
    7
  • 9 Stérilisation
    8
  • 10 Emballage
    8
  • 11 Informations fournies par le fabricant
    8
  • 11.1 Généralités
    8
  • 11.2 Étiquetage de l'emballage primaire
    8
  • 11.3 Étiquetage de l'emballage secondaire
    8
  • 11.4 Instructions d'utilisation
    8
  • 11.5 Informations destinées à la patiente
    9
  • Bibliographie
    11
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