ISO 23908-2011 pdf free download.Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling. 4 Requirements 4.1 General 4.1.1 Where the requirements do not specify forces for activation of the safety feature, the appropriate force shall be determined by using a risk-based approach in accordance with ISO 14971, supported by simulated user studies that mimic actual clinical use by using patient substitutes (e.g. instructional models) rather than actual patients. The study design should be based on statistical considerations and should have clear acceptance criteria. Guidance on conducting simulated user studies is outlined in Annex A. 4.1.2 Once in safe mode, the safety feature(s) of the device shall provide protection against accidental sharps injury until safe disposal of the sharp under expected conditions of use. 4.1.3 It shall be apparent to the user as to when the device is in safe mode. Activation/safe mode shall be communicated to the user in a clear and unmistakeable manner by either visual,tactile and/or audible means. If the manufacturer determines that the user environment requires a permanent indication of safe mode, then a visual indication shall be included. 4.1.4 Activation of the sharps protection feature shall permit the user’s hand(s) to remain behind the exposed contaminated sharp. Safety features may be operated either actively or passively. If active operation is required, one-handed operation is recommended. 4.1.5 The safety result shall ⎯ not negatively affect the intended performance characteristics or proper disposal of the device, ⎯ not impede or adversely affect the intended clinical performance of the device, ⎯ resist inadvertent activation under expected conditions of use. 4.1.6 The performance of the safety feature as described in 4.1.2 to 4.1.5 shall be demonstrated through appropriate simulated or clinical use studies for the specified conditions indicated under the conditions of use. NOTE 1 Appropriate simulated or clinical use studies may be helpful in establishing specifications to meet the requirements of Clause 5. NOTE 2 Annex A contains guidance for simulated or clinical use studies. NOTE 3 IEC 62366 covers the application of usability engineering to medical devices.ISO 23908 pdf download.
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