What is ISO 23908 - Requirements and test methods for evaluating sharps injury protection features about?
ISO 23908 is a European standard that discusses sharps injury protection. ISO 23908 outlines the 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 and are intended to prevent, or reduce the potential for, disease the transmission that could result from accidental, post-use sharps injuries.
ISO 23908 covers may be provided integral to the device or combined with the device before use to achieve sharps injury protection.
Note: ISO 23908 does not give requirements for the storage and handling of the sharp’s protection before its intended use, or for the medical device itself.
Who is ISO 23908 - Requirements and test methods for evaluating sharps injury protection features for?
ISO 23908 on the requirements and test methods for evaluating sharps injury protection features is useful for:
- Manufacturers of hypodermic needles, hollow-bore needles or hollow bore or solid-core needles used for blood sampling
- Medical laboratories
- Sharp injury protection system manufacturers
- Regulatory authorities
Why should you use ISO 23908 - Requirements and test methods for evaluating sharps injury protection features?
The sharps injury protection feature prevents accidental sharps injury. The active safety feature requires an additional step by the user to activate, separate from any action needed to perform the primary intended function of the device. The passive safety feature sharps protection does not require an additional step by the user to activate, separate from any action needed to perform the primary intended function of the device.
ISO 23908 assists you with requirements on activation of the sharps injury protection feature and security of safe mode protection in sharps injury protection systems designed to protect users of medical devices.
ISO 23908 also provides test methods like testing activation of a sharp’s injury protection feature, challenging the device in safe mode, testing access to the sharp in safe mode, and testing simulated clinical use that assists in evaluating and testing sharp injury protection feature to ensure their performance. Additionally, provides the best industry guidance on marking/labelling and instructions for sharps injury protection features.
In addition, prevent, or reduce the potential for, disease transmission which could result from accidental, post-use sharps injuries.
