NF EN ISO 7439

NF EN ISO 7439

April 2023
Standard Current

Copper-bearing contraceptive intrauterine devices - Requirements and tests

This document 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 or other medicinal products.NOTE       Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2023

Number of pages

26 p.

Reference

NF EN ISO 7439

ICS Codes

11.200   Birth control. Mechanical contraceptives

Classification index

S97-032

Print number

1

International kinship

ISO 7439:2023

European kinship

EN ISO 7439:2023
Sumary
Copper-bearing contraceptive intrauterine devices - Requirements and tests

This document 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 or other medicinal products.

NOTE       Some aspects of this document can be applicable to medicated intrauterine devices and IUDs not containing copper.

Replaced standards (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
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Vérification de la qualité
  • 5 Performance clinique prévue
  • 6 Caractéristiques de conception
  • 7 Matériaux
  • 8 Évaluation de la conception
  • 9 Fabrication et contrôle
  • 10 Stérilisation
  • 11 Emballages
  • 12 Informations à fournir par le fabricant
  • A Exigences d'échantillonnage applicables aux essais des DIU contenant du cuivre
  • Bibliographie
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