EN ISO 23908:2013

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) EN ISO 23908:2013

Publication date:   Mar 19, 2013

General information

60.60 Standard published   Feb 6, 2013

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 23908:2011

NOW

PUBLISHED
EN ISO 23908:2013
60.60 Standard published
Feb 6, 2013

REVISED BY

IN_DEVELOPMENT
FprEN ISO 23908

Relations

Adopted from ISO 23908:2011 IDENTICAL