STERISHEET STERILIZATION WRAPS

STERISHEET DUOTM RANGE

DESCRIPTION

Sterisheet sterilization wraps are best in class Sterile Barrier Systems for CSSDs in hospitals and clinics. Sterisheet SMS products are available as interleaved, sealed or single sheets.

STERISHET DUO™

by Sterisheet® is patented, unique combination of two thermally sealed products. Designed as sealed combination of SMS and high quality cellulose based product to ensure the best bacterial barrier and wet pack prevention.

Double non-sequential wrapping with Sterisheet DUO™ is performed in one single step, saves time during wrapping and unwrapping.

COMPOSITION

The selected combination of SMS and cellulose based product:

  • Crepe
  • Reinforced
  • Non Woven

Combo of two different colors (green & blue) for effective and easy defects detection. 3 grades for different strength level (100 gsm, 115 gsm, 120 gsm).

SUITABLE FOR STERILIZATION METHODS

  • Steam
  • EO

APPLICATION

For small, medium-size and heavy trays depending on the grade selected.

SIZES AVAILABLE

Choose standard sizes to optimize your costs.

Product STANDARD SIZES (cm)
90×90 100×100 120×120 137×137
STERISHEETTM DUO 1
STERISHEETTM DUO 2
STERISHEETTM DUO 3
STERISHEETTM DUO 4

Other sizes are also available upon request.

COLORS

PERFORMANCES

Mechanical and bacterial barrier properties are internally tested on a routine basis according to the regulatory requirements of all of our products. Combining them with random tests conducted by external and accredited laboratories lead Sterimed to secure the best performances on Sterisheet products.

Mechanical Properties

Preservation of pack integrity from closure until the point of use depends on the materials resistance to tearing, puncturing and breaching stresses generated all along the distribution with the hospital. Any mechanical weaknesses will increase the risks of event-related ingression of microorganisms into the pack. Excellent mechanical properties will provide you additional safety while using our materials. Optimal strength and resistance provided in every sheet.

Higher the number used in products’ name (from Duo 1 to Duo 3) higher the total grammage of the product and stronger the wrap.

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

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 SMS products conform to the standards below:

EN ISO 11607-1:2017

EN 868-2:2017

OUR WRAPS MANUFACTURING CERTIFICATION

ISO 13485 standard

PACKAGING PRIOR TO USE

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

  • PRIMARY TRANSPORT PACKAGING

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

  • SECONDARY TRANSPORT PACKAGING

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

LABELING

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

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, hold packaging materials at room temperature (20°C to 23°C) and a relative humidity ranging from 30% to 60% for a minimum of 2 hours is a good practice for optimum use performances.

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

Combination of cellulose based product with renewable content rate up to 97-100% and oil derived product, renewable content 0%

Disposal as per local regulations after use.