NF EN ISO 23908
NF EN ISO 23908

NF EN ISO 23908

September 2013
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

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.

Main informations

Collections

National standards and national normative documents

Publication date

September 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

Print number

1 - août 2013

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
NF EN ISO 23908
January 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

Standard replaced by (1)
NF EN ISO 23908
NF EN ISO 23908
August 2025
Standard Current
Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • 5 Méthodes d'essai
  • 6 Informations fournies par le fabricant
  • Annexe A (informative) Lignes directrices pour les simulations d'étude d'utilisateur
  • Annexe B (informative) Méthode d'essai pour tester l'accès au perforant en mode sécurité
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive européenne 93/42/CEE relative aux dispositifs médicaux
  • Bibliographie
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