Medical device classification in GOST R 50444-92

GOST R 50444-92 is the most critical standard for medical devices in Russian regulation. The most critical points are:

  • it is most usable standard despite of scope of this standard, by fact it is applied for all medical devices except of X-Rays, eyeglass optics and eye protection devices,
  • this standard is quiet old and contains special requirements for medical device (in labeling, packaging and so on),
  • national standard which has no generic international standards,
  • contains additional classification rules for medical devices.

Let’s discuss this classification in details:

GOST R 50444 contains 3 classification scheme for medical devices (MD):

1. By the consequences of failure:

A (In Russian – А) – Failure of these MDs leads dangers for patient’s life;

B (Б) – Failure of these MDs doesn’t lead direct risk for patient’s life, but cause harm it’s health;

С (В) – Failure of these MDs leads decrease effectiveness of treatment or elongates this;

D (Г) – Failure of these MDs doesn’t lead any consequences for patient;

2. By movability:

1 – Stationary;

2 – Wearable, portable and movable devices, NOT INTENDED for working during the transportation in hospital;

3 – Wearable, portable and movable devices, INTENDED for working during the transportation in hospital;

4 – Transportable and permanently installed on movable medical platforms, NOT INTENDED for working during transportations;

5 – Transportable and permanently installed on movable medical platforms, INTENDED for working during transportations.

III. Per safety requirements (electrical safety) according to GOST 30324.0/GOST R 50267.0

This classification is provided here – GOST 30324.0/GOST R 50267.0, IEC 601-1-88 (current – IEC 60601 group of standards in action).

IV. Climatic zone classification. Critical point for storage, operation and transportation conditions for medical devices – quite different from international rules – detailed information by link.