ISO 23908:2011
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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Scope
Normative references
Terms and definitions
Requirements
General
Activation of the sharps injury protection feature
Security of safe mode protection
Test methods
General
Testing activation of a sharps injury protection feature
Principle
Apparatus
Procedure
Challenging the device in safe mode
General
Principle
Apparatus
Procedure
Testing access to the sharp in safe mode
Testing simulated clinical use
Test report
Information supplied by the manufacturer
General
Marking/labelling
Instructions for use
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Related Information
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Scope
Normative references
Terms and definitions
Requirements
General
Activation of the sharps injury protection feature
Security of safe mode protection
Test methods
General
Testing activation of a sharps injury protection feature
Principle
Apparatus
Procedure
Challenging the device in safe mode
General
Principle
Apparatus
Procedure
Testing access to the sharp in safe mode
Testing simulated clinical use
Test report
Information supplied by the manufacturer
General
Marking/labelling
Instructions for use