ISO 23908:2011 PDF

Scope: This International Standard gives reduirements 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. lt does not give requirements for the storage and handling of the sharps protection before its intended use, Or forthe medical device itself.

ISO 23908:2011 Referenced Document

ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
ISO 16269-6 Statistical interpretation of data - Part 6: Determination of statistical tolerance intervals*， 2014-01-01 Update

2011 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