Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
|Publication Date:||11 June 2011|
|ICS Code (Other medical equipment):||11.040.99|
|ICS Code (Syringes, needles and catheters):||11.040.25|
This International Standard 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.