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
For instance, according to the TNO final pack test method, validating the materials & the folding technique, STERISHEET 363 SMS exhibits a BARRIER PROTECTION > 99,99%
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 conform with the standards below:
EN ISO 11607-1:2017
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 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 product ID.
● SECONDARY TRANSPORT PACKAGING
Secondary packaging is a neutral brown color cardboard box providing transportation stress resistance.
Product traceability is fully insured through labelling according regulations on each transport packaging.
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 bedone 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 inhealth care facilities” recommendations in chapters 8.3 Package configurations and preparation subchapter8.3.1 General considerations: “Before use, packaging materials should be held at room temperature (20°C to23°C) and at a relative humidity ranging from 30% to 60% for a minimum of 2 hours shall be followed as agood practice for optimum use performances.
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
Oil derived product, renewable content 0%.
Disposal as per local regulations after use.