NF EN ISO 7439

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.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2009

Number of pages

21 p.

Reference

NF EN ISO 7439

ICS Codes

11.200   Birth control. Mechanical contraceptives

Classification index

S97-032

Print number

1 - 23/09/2009

International kinship

ISO 7439:2002

European kinship

EN ISO 7439:2009
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 EN ISO 7439
May 2002
Standard Cancelled
Copper-bearing intra-uterine contraceptive devices - Requirements, tests

Le présent document prescrit les exigences et décrit les méthodes d'essai des dispositifs intra-utérins contenant du cuivre, et de leurs systèmes d'insertion. Il traite des performances, de la conception, des matériaux, ainsi que des informations fournies par le fabricant. Il est à lire conjointement avec la NF EN ISO 14630 (indice de classement S94-001).

Standard replaced by (1)
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.

Table of contents
  • Avant-propos
    v
  • Introduction
    VI
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Performance prévue
    2
  • 5 Caractéristiques relatives à la conception
    2
  • 6 Matériaux
    3
  • 7 Evaluation de la conception
    3
  • 8 Fabrication et contrôle
    7
  • 9 Stérilisation
    7
  • 10 Emballage
    7
  • 11 Informations fournies par le fabricant
    7
  • Annexe ZZ (normative) Normes internationales et européennes correspondantes pour lesquelles des équivalents ne sont pas donnés dans le texte
    10
  • Bibliographie
    11
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