## 3 Demonstration of the Steps Based on the hypACT Inject Auto Device  
### Technological Steps  
1. The intended use of the medical device: The device was developed to accomplish point of care therapy for knee osteoarthritis. It is suitable to draw blood from a patient, and after a physical separation, a concentrated growth factor containing autologous serum (serum from platelet-rich fibrin, SPRF) is isolated aseptically in a closed system. In cases when the physician intends to use SPRF, this serum fraction can be isolated in an aseptic way by the device and injected to the knee of the patient immediately. 2. The user needs were collected and used to create the functional requirement specifications. The user needs were found to be the following: * Device can be used in medical facilities. * The device can be used in autologous therapy. * The plunger can be pulled by one or two fingers. * The device has to withstand drawing and injecting therapeutically useful amounts of blood. * The clotted serum fraction can be separated from the red blood cells. * The device has to fit in a centrifuge bucket where a 50 mL conical centrifuge tube fits. * Needles or butterfly needles can be attached to the syringe. * The device shall not leak. \begin{table}
\begin{tabular}{c l} \hline \multicolumn{1}{c}{**Standard**} & \multicolumn{1}{c}{**Regarding Subject**} \\ \hline ISO 10993-4:2017 & Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood \\ \hline ISO 10993-5:2009 & Tests for in vitro cytotoxicity \\ \hline ISO 10993-9:2009 & Framework for identification and quantification of potential degradation products \\ \hline ISO 10993-10:2010 & Tests for irritation and skin sensitisation \\ \hline ISO 10993-11:2017 & Tests for system toxicity \\ \hline ISO 10993-13:2010 & Identification and quantification of degradation products for polymeric medical devices \\ \hline ISO 1135-4:2015 & Transfusion equipment for medical use—Part 4: Transfusion Sets for Single Use \\ \hline EN 1041:2008+A1:2013 & Information supplied by the manufacturer of Medical Devices \\ \hline ISO 15223-1:2016 & Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements \\ \hline EN 1422:2014 & Sterilisers for medical purposes—Ethylene oxide sterilisers — Requirements and test methods \\ \hline ISO 7886-1:2017 & Sterile hypodermic syringes for single use—Part 1: Syringes for manual use \\ \hline ISO 7886-4:2018 & Sterile hypodermic syringes for single use—Part 4: Syringes with re-use prevention feature \\ \hline ISO 11135:2014 & Sterilisation of health care products—Ethylene oxide—Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices \\ \hline ISO 11138-2:2017 & Sterilisation of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilisation processes \\ \hline ISO 11737-1:2018 & Sterilisation of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products \\ \hline ISO 11737-2:2009 & Sterilisation of medical devices—Microbiological methods—Part 2: Tests for sterility performed in the definition, validation and maintenance of a sterilisation process \\ \hline ISO 14937:2009 & Sterilisation of health care products—General requirements for characterisation of a sterilisation agent and the development, validation and routine control of a sterilisation process for medical devices \\ \hline ISO 2233:2000 & Packaging—Complete, filled transport packages and unit loads—Conditioning for testing \\ \hline ISO 14155:2011 & Clinical investigation of medical devices for human subjects—Good clinical practice \\ \hline \end{tabular}
\end{table} 
Table 2: Cont. The device shall be used to draw blood from human patients and the contents of the syringe are compatible to be used therapeutically. * The device can be stored prior to use without any changes occurring. * Can be centrifuged at high speed for a short period of time.