Sterisheet Sterilization Wraps: Sterisheet 357 Wet Laid NW

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PRODUCT DATA SHEET

STERISHEET STERILIZATION WRAPS


STERISHEET 357 Wet Laid NW

STERISHEEET 160 CREPE


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DESCRIPTION
Sterisheet sterilization wraps are high quality Sterile Barrier Systems for CSSDs in hospitals and
clinics. Our production is 100% healthcare dedicated.
STERISHEET WET LAID NW offers superb combination of fluid repellency, drapeability, softness
and strength.

COMPOSITION
Belongs to family of wet laid nonwoven made of cellulose, reinforced with up
to 30% synthetic fibers and 20% synthetic binders.

SUITABLE FOR THE FOLLOWING STERILIZATION METHODS

o Steam
o EO
RECOMMENDATIONS:
o Low temperature
✓ Be sure to use 2 layers of sterilization
o Steam Formaldehyde (LTFS)
wraps
✓ Our interleaved solutions save your
Application time while wrapping and storage space
For larger trays and heavy duty packs, orthopedics sets. in your CSD
Inner wrap for reusable containers. ✓ In case of excessive humidity, the use
of Wet Laid NW should be considered
vs 100 % Polypropylene materials.
Sizes Available
The following are standard sizes available for all our customer’s
needs. Choose standard sizes to optimize your costs. Other sizes
are also available upon request.
60x60 cm 100x100 cm
75x75 cm 120x120 cm
90x90 cm 137x137 cm

Product Data Sheet - STERISHEET 357 Wet Laid NW l VERSION 1 l Edited on April 25- 2018

®
STERISHEET IS A BRAND OF

www.sterimed.fr
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PRODUCT DATA SHEET

STERISHEET STERILIZATION WRAPS


STERISHEET 357 Wet Laid NW

STERISHEEET 160 CREPE


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COLORS

PRODUCT PROPERTIES:
Why STERISHEET Wet Laid NW?
Mechanical protection and bacterial barrier properties
✓ Higher fluid repellence, drapeability
are tested carefully. Our internal laboratory provides
✓ Softness for daily work
standardized tests on all of our products. Together
✓ Strength and tear resistance
with tests conducted by external independent
improved by using synthetic fibres
laboratories we secure the best possible results on and binders
Sterisheet products.

Mechanical Properties
Preservation of pack integrity from closure till the point of use
STERISHEET 357 WET LAID NW
depends on the materials resistance to tearing, puncturing, PROPERTIES TYPICAL
breaching stresses generated all along the distribution, SUBSTANCE 57 g/m²
handling and storage with the hospital. Any mechanical THICKNESS (BULKY MATERIAL) 250 μm
TENSILE STRENGTH MD 2.50 kN/m
weaknesses will increase the risks of event related ingression
TENSILE STRENGTH CD 1.00 kN/m
of microorganism into the pack. BURST STRENGTH 190 kPa
Excellent mechanical properties will provide you additional TEARING STRENGTH MD 1 100 mN
safety while using our materials. Optimal strength and TEARING STRENGTH CD 1 550 mN

resistance provided in every sheet.

Bacterial Properties
Sterilization wraps must prevent microorganisms’ ingression inside the package.
To reach this performance, different types of testing have to be performed on the products to
reproduce both kind of ingression vehicles possible:
• Airborne ingression
• Waterborne ingression

Product Data Sheet - STERISHEET 357 Wet Laid NW l VERSION 1 l Edited on April 25- 2018

®
STERISHEET IS A BRAND OF

www.sterimed.fr
22

PRODUCT DATA SHEET

STERISHEET STERILIZATION WRAPS


STERISHEET 357 Wet Laid NW

STERISHEEET 160 CREPE


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COMPLIANCE TO STANDARDS
Sterisheet products range is classified as a Class I Medical Device according to the European Medical Device
Directive (MDD). Its CE marking illustrates the relevant compliance.
Sterisheet products are conform with standards below:
EN ISO 11607-1:2017
EN 868-2:2017

OUR WRAPS MANUFACTURING CERTIFICATION


ISO 13485 standards

PACKAGING PRIOR TO USE


Sheets presentation is optimized by adjusted folding depending on the size and type of the product. We have
tested carefully the best solution to ensure the most convenient handling for end users.

• PRIMARY TRANSPORT PACKAGING


Number of sheets is maximized and wrapped in transparent polyethylene bag with quick product ID.

• SECONDARY TRANSPORT PACKAGING


Secondary packaging is a neutral brown color cardboard box with transportation stress resistance.

LABELLING
Product traceability is fully insured through labelling according regulations on each transport packaging.

STORAGE CONDITIONS
Sterimed recommends the following storage conditions for best performance of sterilization wraps: Storage in a
cool, dry location away from direct exposure to natural light, strong artificial light & UV sources. Cardboard boxes
should never be stored in direct contact with the floor. Storage of the products shall be done in areas that are not
subject to extreme temperature changes such as in contact with heated objects, vents or cold walls.
As per AAMI ST79 “Comprehensive guide to steam sterilization and sterility assurance in health care facilities”
recommendations, before use, holding packaging materials at room temperature (20°C to 23°C) and at a relative
humidity ranging from 30% to 60% for a minimum of 2 hours is a good practice for optimum use performances.

Product Data Sheet - STERISHEET 357 Wet Laid NW l VERSION 1 l Edited on April 25- 2018

®
STERISHEET IS A BRAND OF

www.sterimed.fr
22
PRODUCT DATA SHEET

STERISHEET STERILIZATION WRAPS


STERISHEET 357 Wet Laid NW

STERISHEEET 160 CREPE


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USE BY DATE
Provided the above storage conditions are met, the upper limit of the time interval during which the performance
characteristics of the sterile barrier system are demonstrated is 5 years of the manufacturing date.
.

ENVIRONMENTAL IMPACT & WASTE MANAGEMENT


STERIMED Infection Control is committed to the protection of the environment and the
communities it belongs to.
STERISHEET 357 Wet Laid NW – renewable content and low bulkiness ratio are the
features that contributes to positive environmental scoring.

Disposal as per on local regulations after use.

Product Data Sheet - STERISHEET 357 Wet Laid NW l VERSION 1 l Edited on April 25- 2018

®
STERISHEET IS A BRAND OF

www.sterimed.fr

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