NF EN ISO 23908

NF EN ISO 23908

August 2013
Standard Current

Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2013

Number of pages

24 p.

Reference

NF EN ISO 23908

ICS Codes

11.040.25   Syringes, needles and catheters
11.040.99   Other medical equipment

Classification index

S93-090

Print number

1 - 05/08/2013

International kinship

ISO 23908:2011

European kinship

EN ISO 23908:2013
Sumary
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection.

It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.

Replaced standards (1)
NF EN ISO 23908
July 2011
Standard Cancelled
Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

<p>ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection.</p> <p>It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences
    2
  • 4.1 Exigences générales
    2
  • 4.2 Exigences pour l'activation du dispositif de protection contre les blessures par perforants
    3
  • 4.3 Exigences de sécurité de la protection en mode sécurité
    3
  • 5 Méthodes d'essai
    3
  • 5.1 Généralités
    3
  • 5.2 Méthode d'essai pour l'activation du dispositif de protection contre les blessures par perforants
    4
  • 5.3 Méthode d'essai pour les dispositifs complexes en mode sécurité
    5
  • 5.4 Méthode d'essai pour tester l'accès au perforant une fois en mode sécurité
    6
  • 5.5 Méthode d'essai pour une utilisation clinique simulée
    6
  • 5.6 Rapport d'essai
    6
  • 6 Informations fournies par le fabricant
    7
  • 6.1 Généralités
    7
  • 6.2 Marquage/étiquetage
    7
  • 6.3 Instructions d'utilisation
    8
  • Annexe A (informative) Lignes directrices pour les simulations d'étude d'utilisateur
    9
  • Annexe B (informative) Méthode d'essai pour tester l'accès au perforant en mode sécurité
    11
  • Bibliographie
    12
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