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Conformity evaluation for medical devices

„Test certificates for sterile barrier systems and sterilization packaging materials“

Based on the medical device directive (MDD) 93/42/EEC (last amendment by the directive 2007/47/EC), the ISO 11607-1 sets requirements for materials, sterile barrier systems and packaging systems for packaging for terminally sterilized medical devices.

For

  • plain, adhesive coated and creped sterilization paper
  • nonwoven sterilization wrap
  • nonwoven materials of polyolefines (uncoated and coated)
  • preformed sterile barrier systems (sterilization pouches / reels, paper pouches, blister packaging)

we can state the conformity of your products with section

  • 5.1.6 a) microbial barrier
  • 5.1.6 c) physical and chemical properties
  • 5.1.6 d) compatibility with respect to forming and sealing processes
  • 5.1.6 e) compatibility with respect to the intended sterilization process(es)

of the ISO 11607-1 in a test certificate.

 

„Test certificates for permanent paper“

The conformity of your products with the standards

  • DIN 6738 – Paper and board – Lifespan classes
  • DIN EN ISO 9706 – Paper for documents – Requirements for permanence
  • NEN 2728 –Permanent paper for archives – Requirements and test methods

can be stated in a test certificate.

 

 

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