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.
