Medical device classification in GOST R 50444-92
GOST R 50444-92 (equivalent to GOST 20790-93) is an important standard for many types of medical devices in Russia, and is particularly important for their marketing authorization procedure; however it has several specific features to be mentioned:
- Despite its vaguely described scope (which is as medical devices, medical apparatus, medical equipment and sets of medical equipment, except X-ray medical equipment as per GOST 26140, eyeglasses and related optics (corrective eyeglasses, eyeglasses frames, optical lenses for eyeglasses and contact lenses), safety eyeglasses and facial shields), it is in fact applicable for almost all medical items (except for the aforementioned and those for which particular standards are applicable, with a higher priority of requirements). In actual fact, for any particular medical item it is much easer to determine why GOST R 50444-92 shall not be applicable, but not vice versa.
- This standard is rather old and needs reviewing.
- It contains additional classification requirements for medical devices.
- It is a state standard, and some of its requirements could hardly be aligned with the requirements set forth by the standards of other countries.
Let us have a closer look at this, since classification issues are often important for the final number of marketing authorization certificates (registration certificate), as well as for the situation when the medical device concerned is associated with more than one registration certificate, and for the authorization process in general.
GOST R 50444 includes several classifications of medical devices:
I. Depending on the possible effects of in-use failure, there are four classes (A, B, C, D):
А – class are devices with critical failure effect for which the failure means immediate threat to life for the patient;
B – class are devices which, if they fail in use, will not immediately endanger the patient’s life but could result in adverse effects to his/her health;
C – class are devices which, if they fail in use, will result in less efficient or unnecessarily prolonged treatment (non-critical), or result in an increased load on medical or service personnel;
D – are devices which, if they fail in use, will not result in damage to major functions but only in changes of certain functionalities without consequences for the patient.
This classification for now is not obligatory to declare, but still recommended.
II. Depending on the mechanical loads taken, all medical devices are divided into 5 groups:
2: portable, i.e. movable and mobile, not intended for operation during transfer and transitions within the same medical facility;
3: portable, i.e. movable and mobile, intended for operation during transfer and transitions within the same medical facility;
4: transportable, including permanently mounted on mobile medical equipment, not intended for operation during transportation or transfer;
5: transportable, including permanently mounted on mobile medical equipment, intended for operation during transportation or transfer, and the mobile medical equipment itself.
This classification is important for the grouping of medical devices and for the decision on including them in the same MAC, since devices belonging to different groups usually cannot be registered under the same MAC.
III. Electrical safety (for active devices)
Depending on the safety requirements, all devices containing electrical circuits, are to be divided into classes and types according to GOST 30324.0 (equivalent to GOST 50267.0 and IEC 601-1-88). Nowadays GOST R IEC 60601-1-2010 or similar standards are used instead of the aforementioned standards. For example, GOST R IEC 60601-1-2010 includes Classes, Categories and other specific features of medical devices which may affect the grouping of a medical device, in the event when different models belong to different classifications.
IV. Classification based on the ability to withstand certain environmental conditions (Climatic zone classification)
Let us have a look at the requirements set forth in the standard concerned:
- “Devices to be operated within the human body and organs containing biological fluids such as blood, bile, urine, as well as skin and mucous membranes secretions, shall be available in 2 environmental modifications, called U and Т, as per GOST 15150, category 6, according to the requirements of GOST R 50444-92”.
In particular, this requirement is applicable to the implanted devices such as stents, embolization coils, dental implants etc. They have to me marked as T6 with regard to their environmental class, and environmental requirements for those devices shall be the same as for the T6 class.
Note. U6 and T6 class devices shall be operational under an ambient temperature range of 32 to 42°C, and the remaining requirements may be set by the manufacturer at its own discretion.
- “Devices for which all parts and components are intended for operation in the open air, have to comply with the classes UKHL4.2, U1, U1.1, U2, U3, У5, Т1, Т1.1, Т2, Т3, Т5, О4.1 and О4.2. Other modifications and categories provided in the GOST 15150 are also acceptable”.
In actual fact, requirements set forth in the first sentence of the paragraph concerned may be applied not only to devices for which “all parts or components are intended for operation in the open air”, e.g. dressings, wheelchairs, ECG devices, but also for all other devices except implants, such as examination gloves, catheters, surgical knives etc.
A statement of the exact environmental modification for those groups of medical devices manufactured abroad is not obligatory; in this case environmental requirements statements are of a higher priority. Detailed information by link. Local (Russian) manufacturers still have to indicate the environmental modification for their devices. Most often it is UKHL 4.2.