COMPRESSION STOCKING, class II, single patient, pair, XXL

STD EPHYCSTO2S2X

Valid Article

Single patient multiple use A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

COMPRESSION STOCKING

Definition

A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns); it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-person-use device.

Specifications

4 classes based on their pressure value

  • Class 1 : 18-21 mm Hg / 2.4-2.8 kPa; Light pressure with a superficial drainage system of moisture and waste. This class applies for/to people with:
    • heavy and tired legs,
    • a light form of varicose veins,
    • preventive wear during pregnancy,
    • a slight tendency to oedema
  • Class 2 : 23-32 mm Hg / 3.1-4.3 kPa. Moderate pressure with a superficial drainage system of moisture and waste. This class applies for/to people with:
    • varicose veins,
    • swollen legs during pregnancy,
    • operations of varicose veins,
    • a treatment of vein problems,
    • a slight tendency to oedema
  • Class 3 : Strong pressure with a superficial and deep drainage system of moisture and waste. This class applies for/to people with:
    • varicose veins due to damaged deep veins,
    • chronic venous insufficiency,
    • early stage lymphoedema,
    • a strong tendency to oedema
  • Class 4 : Very strong pressure with a superficial and deep drainage system of moisture and waste. This class applies for/to people with:
    • very severe venous diseases,
    • advanced lymphoedema.
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Quality Standards Comment

For a neutral and reproducible testing method in Europe for medical compression stockings, couple of standards have been developed like in Germany RAL-GZG standard, in France AFNOR and in Great Britain BSI. These standards include exactly defined procedures how to classify a medical compression stocking. Preliminary ENV 12718 was created as a mutual European standard, but in the end it was refused by the majority of the members of the standardization committee after 13 years. Only the German standard RAL-GZG took over the reasonable requirements of the ENV 12718.

Technical specifications

Length: Tigh high (AG): 64-75 cm

Circumference measurements: unit cm

SizeSMLXLXXL
CB18-2121-2423-2626-3030-33
Cb123-2625-3029-3332-3635-39
CC30-3433-3837-4039-4342-46
CD28-3332-3635-3938-4241-45
CE32-3534-3837-4140-4544-49
CF40-4342-4746-5049-5342-56
CG46-5049-5554-5958-6061-64
CT75-9085-10095-110100-115105-120

Dimensions


Instructions for use

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MSF requirements

Indicated in patients at risk for venothromboembolism who have contra-indications to chemical thromboprophylaixs with heparin or low molecular weight heparin (LMWH) e.g. due to bleeding risks.

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