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Materials: |
Cellulose fibre. |
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Meets requirement in EN 868-1-2 standard. |
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- Paper grammage: 60gr/m2 |
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- Porosity 50µ maximum. |
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-Water repellence, test time: minimum 20 seconds. |
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- Tensile strength and drapeability. |
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- Colour: white, green or blue. |
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- Size sheet: 90 x 90cm. |
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Unit of use: |
1 sheet non-sterile, single-use. |
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Packaging unit: |
Box of 250 sheets. |
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Labelling: |
Product name, size, reference number, lot number, expiry date, manufacturer’s name and address, and CE mark and reference number of notifying body. |
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Storage: |
Humidity between 30-60%. |
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Temperature: maximum 40°C, minimum 10°C. |
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Other requirements meets standards: |
EN ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems |
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EN 868-2 standard: Packaging materials and systems for medical devices which are to be sterilized – Part 2: Sterilization wraps - Requirements and test methods |