Material: |
Nonwoven fabric (cellulose/polyester) and polyethylene
Nonwoven fabric, made of synthetic fibres |
Description: |
- Two or three layers, nonwoven fabric |
|
- Top layer (1st) highly absorbent nonwoven fabric |
|
- Second (2sd) or intermediate layer, impermeable material (e.g., polyethylene) to form a 100% germ-barrier against bacterial migration and soaking. |
|
- Bottom layer (3rd) absorbent tissue; to soak up patient’s sweat. |
|
- Supple, easy to drape. |
|
- Traction resistant: difficult to tear. |
|
- With or without a slit or hole. |
|
- Colour: blue or green, uniformly green for OT |
|
- Different sizes: |
MMREDSURD0506H |
50 x 60cm |
Hole Ø 5-6cm, centrally placed, minimum 2 layers |
MMREDSURD0709 |
75 x 90cm |
Plain drape, minimum 2 layers |
MMREDSURD0709A |
75 x 90cm |
Plain drape with adhesive strips |
MMREDSURD0915 |
90 x 150cm |
Plain drape, minimum 2 layers, 3 preferable |
MMREDSURD1524 |
150 x 240cm |
Plain drape , minimum 2 layers, 3 preferable |
MMREDSURDCM |
l 145-150 x w 80cm |
Instrument table cover, pillow case type, waterproof |
|
|
Unit presentation: |
1 drape in double packaging, peel pack, sterile, single-use |
Packaging and labelling: |
Primary packaging: |
|
Unit presentation: Multilingual product description (English, French and Spanish, others when available), size, "sterile" and sterilization method, lot number, expiry date by year and month, "for single use", CE mark and reference number of notifying body, and manufacturer’s name and address. |
|
Secondary packaging: Protected unit; labelling is the same as that of the unit presentation. |
|
Additional required information: Number of units per secondary packaging, information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.) |
Over packaging: |
Packaging unit: Strong carton |
Other requirements: |
Must comply with Medical Device Directive 93/42/EEC |
Meet standards: |
EN 13795-2:2004: Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. Test methods |