ISO 23908-2011 pdf free download.Sharps injury protection一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 appropnate 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 andlor 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 I Appropciate simulated or dinical use studies may be helpful in establishing specifications to meet the requirements of Clause 5.
NOTE 2 Annex A contains guidance for simulated or dinical use studies.
NOTE 3 IEC 62366 covers the application of usability engineering to medical devices.
4.2 Activation of the sharps injury protection feature
Active sharps injury protection features shall be able to be activated immediately after intended use.
Passive sharps injury protection features shall enter safe mode immediately after intended use.
The sharps injury protection feature shall be able to be activated by a force appropriate for the intended users of the device (e.g. patients, health care professionals o family members). An appropriate force shall be selected that eases actuation and avoids unintended actuation.
The appropriate activation forces shall be determined using a risk-based approach in accordance with
ISO 14971. The manufacturer shall confirm that these force values are the values at which the sharps injury
protection feature can be activated. These force values shall be obtained using the methodology outlined in
Clause 5.
4.3 Security of safe mode protection
Once in safe mode, the safety feature shall
a) resist forces so as to prevent unintended exposure to the sharps, when tested in accordance with 53, and
b) minimize the risk of accidental access to the sharp, when tested in accordance with 5.4. Using a risk-based approach in accordance with ISO 14971. the manufacturer shall determine appropriate
minimum overriding forces, These force values shall be obtained using the methodology outlined in Clause 5. 5 Test methods
5.1 General
Unless otherwise specified in the relevant device standard(s), all tests and test evaluations shall be performed at the following standard atmosphere conditions:
— temperature: (23±5)°C;
— relative humidity: (50 ± 25) %.
The device with integrated sharps injury protection or stand-alone sharps injury protection device that is tested shall have been subjected to storage for at least 4 h under these conditions immediately prior to testing/evaluation.ISO 23908 pdf download.