Why it is important to use class 2b safety devices in ReLife plasma therapy.

The danger of substituting classes of medical devices.

Using medical devices of class "2a" instead of "2b" can pose a serious threat to patient health. In regenerative medicine, and especially in ReLife plasma therapy, this is unacceptable, since the safety class determines not only the quality of the procedure but also the safety of the blood, tissues and the resulting plasma ("ReLife plasma").

What are the safety classes of medical devices.

The classification of devices by risk level is regulated by international and Eurasian standards.

  • Class 1 — minimal risk, e.g. dressings.
  • Class 2a — moderate risk: devices for short-term or superficial use (inhalers, contact lenses).
  • Class 2b — elevated risk: devices in contact with blood, tissues or internal organs, used for prolonged periods (including ReLife PRP tubes and other ReLife PRP equipment).
  • Class 3 — extremely high risk (e.g. implants or heart valves).

Differences between 2a and 2b: why it matters for ReLife.

  • Class 2a devices undergo basic certification and are designed for short-term use.
  • Class 2b devices used in ReLife PRP therapy systems have stricter requirements for biocompatibility, sterility and quality control. They undergo clinical trials and certification in accordance with the medical standards of the EAEU and Kazakhstan.

What can happen if class 2a devices are used instead of 2b.

  1. Reduced strength and reliability. Class 2a tubes and equipment components may not withstand centrifugation or prolonged contact with blood. This can lead to material failure and loss of the plasma sample.
  2. Biocompatibility problems. Class 2b ReLife PRP tubes are tested for the absence of toxicity and allergic reactions. Replacing them with 2a devices increases the risk of inflammation, infection and hemolysis.
  3. Inaccurate control and unstable results. Working with blood requires a precise balance of anticoagulant (e.g. sodium citrate). A class mismatch can change the properties of ReLife plasma and reduce the effectiveness of plasma therapy.
  4. Lack of clinical trials. Class 2a devices do not undergo the full testing cycle required for class 2b, which makes them unsafe for ReLife Medical Kazakhstan procedures.
  5. Material degradation on prolonged contact. Class 2a materials can break down or react with biological fluids, leading to plasma contamination and loss of sterility.

Examples of risks:

PRP systems. Using uncertified class 2a tubes can lead to wall rupture during centrifugation.

Implantation and injection procedures. Contact with uncertified material increases the risk of inflammation.

ReLife systems. Genuine ReLife tubes are certified as class 2b and are intended for safe ReLife plasma therapy.

Why ReLife uses only class 2b devices.

ReLife Kazakhstan and the prp.zone platform strictly comply with medical standards. All products — from ReLife PRP equipment to ReLife PRP tubes — belong to class 2b and are certified in accordance with EAEU requirements.

This ensures:

  • sterility and safety of procedures;
  • stable results when separating plasma;
  • compliance with the medical standards of Kazakhstan and international markets;
  • a solid reputation among doctors and clinics.

Using class 2b devices is a guarantee of safety and effectiveness for the patient. Substituting class 2a devices can lead to complications, lower quality of ReLife plasma and loss of trust in the procedure.

If you want to be sure of quality and certification, choose original ReLife tubes, ReLife PRP equipment and consumables only from the official supplier — prp.zone.