NF EN ISO 9626

NF EN ISO 9626

June 1995
Standard Cancelled

Stainless steel needle tubing for the manufacture of medical devices.

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Main informations

Collections

National standards and national normative documents

Publication date

June 1995

Number of pages

15 p.

Reference

NF EN ISO 9626

ICS Codes

11.040.25   Syringes, needles and catheters

Classification index

S93-004

Print number

1 - 16/03/2011

International kinship

ISO 9626:1991

European kinship

EN ISO 9626:1995
Standard replaced by (1)
NF EN ISO 9626
October 2016
Standard Current
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device. It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge). It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.

Table of contents
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Matériaux
    1
  • 4 État de la surface
    1
  • 5 Propreté
    1
  • 6 Limites d'acidité et d'alcalinité
    1
  • 7 Désignation de la dimension
    1
  • 8 Dimensions
    2
  • 9 Rigidité
    2
  • 10 Résistance à la rupture
    3
  • 11 Résistance à la corrosion
    3
  • Annexe A Méthode de détermination de l'acidité ou de l'alcalinité des tubes
    5
  • Annexe B Méthode de préparation des extraits
    6
  • Annexe C Méthode d'essai de rigidité des tubes
    7
  • Annexe D Méthode d'essai de résistance des tubes à la rupture
    8
  • Annexe E Méthode d'essai de résistance des tubes à la corrosion
    9
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