Papersheet,crepe,for ster. pack/PAC-100

General Description
Papersheet, crepe, for sterilization pack, pack of 100.
Crepe paper sheet for packing (wrapping) medical devices for sterilization with steam. Provides steam penetration and fluids regulation, with optimal protection of the sterile products. Permits safe sterilization and storage of sterile medical devices.

Technical specifications:
The following attributes are compliant with EN ISO 11607-1&2 (EN 868-1 &2)
·Medical grade paper, creped, cellulose based, with 58-62 g/m2.
·Controlled porosity.
·Bacterial barrier.
·Tensile strength
·Drapability.

Paper sheet size: 0.9-1.1 x 0.9-1.1 m
Single-use.
Non sterile.

Storage and transportation:
Avoid storage at high temperatures and humidity levels, Store in a clean and safe environment: avoid dust, risk of punctures or other environmental risk of damage.

Packaging and labeling:
Primary packaging:
One hundred (100) paper sheets in a plastic bag.
Labelling on the primary packaging:
Name and/or trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics. If the packaging is not transparent, it must bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the
product in the packaging.
Lot number prefixed by the word "LOT" (or equivalent harmonised symbol) (if applicable).
Expiry date by year and month, prefixed by the word "EXP" (or equivalent harmonised symbol) (if applicable).
The words "for single use" (or equivalent harmonised symbol).
The words "destroy after use" (if space allows).
Number of units per primary packaging (if applicable).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Manufacturer's instruction for use.
Alternatively, the instruction for use can be indicated on a separate insert.
Over packaging: Packaging unit
.
Instructions for use
Crepe paper sheets to be used for packing (wrapping) medical devices for sterilization with steam (e.g. surgical instruments, medical linen).
Note: Steam sterilization activities shall be performed by qualified staff only, meaning trained staff on related procedures and equipment.
Paper crepe packing (wrapping) for sterilization with steam:
It requires double layer to make double wrap (see steps below):
- Wrap the medical devices in the first layer, folding the corners of the paper sheet (for easy unwrapping).
- Put this pack on the second layer, and wrap it following the same method (folding corners for easy unwrapping).
- Place the TST control spot indicator (item number below) inside the second layer.
- Close the last corner of the second layer with the masking tape (item number below).
- Write on the masking tape: the pack content and the date of sterilization.
Note: NEVER write on the paper crepe (risk of perforation).
Necessary items for steam sterilization packs shall be available on site:
- 0167100 Papersheet, crepe,for sterilization pack
- 0558100 Indicator, TST control spot/PAC-300
- 0167110 Masking tape,for sterilization pack

Safety process
The crepe paper sheet is for single use only.
Check the integrity of each unit before use.
Do not use if damaged.

Weight and volume:
Estimated weight: 7kg
Estimated volume: 0.022CDM