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.
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.
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
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.