Papersheet,crepe,ster.pack. /PAC-250/252

GENERAL DESCRIPTION
Crepe paper sheets, for sterilization packing, pack of 250/252.

INTENDED USE
Paper sheets intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

TECHNICAL SPECIFICATIONS
Good permeability to steam.
Low permeability to air.
Good microbiological barrier.
Cellulose based.
Grammage: 58 - 62 g/m²
Porosity: 50µm maximum.
Water repellence time: at least 20 seconds.
Tensile strength and drapeability in accordance with EN 868-2
Non-sterile and single use.
Size of the individual sheets: 0.9 x 0.9 m
Permits safe sterilization and storage of sterile medical devices for a maximum of 15 days.

SUPPLIED WITH
Instructions for use in English.

ITEMS REQUIRED, BUT NOT SUPPLIED
S0558100, Indicator,TST control spot/PAC-300
S0845176, Masking tape, type 1 steam indicator

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).
The crepe paper sheet is for single use only.
Check the integrity of each unit before use, and do not use if damaged.

SHELF LIFE
Between 24 and 36 months from date of manufacture.

ENVIRONMENTAL CONDITIONS
Storage conditions: 15 - 30°C / 35 - 50% RH.

WEIGHT AND VOLUME (Packaged)
Weight: 13.2 kg.
Volume: 66.30 dm³.

COMPONENT OF A KIT
S9901030 - IEHK2017,kit,suppl.3-renewable

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDR 2017/745 as Class I device.

SAFETY AND PRODUCT STANDARDS
- EN 868-2 : 2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods.
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems.

NOMENCLATURE
GMDN Code: 13735