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.