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Sudemed Tıbbi Ürünler
Sudemed Tıbbi Ürünler

Relevant Standards

Sudemed Tıbbi Urunler | Relevant Standards
TS EN 868-2
Title: Packaging Materials and Systems - For Medical Devices To Be Sterilized;
Section 2: Sterilization Packaging - Properties and Test Methods
Scope of the Standard: This part of the EN 868 series defines the specific requirements and test methods for the sterilization wrap suitable for use in medical devices to be sterilized. This chapter does not impose additional requirements on the general requirements of Chapter 1, but provides guidance based on various elements of previous, relevant national standards.
 
TS EN 868-3
Title: Packaging Materials and Systems - For Medical Devices To Be Sterilized,
Part 3: Paper Bag (EN 868-4) Production and Paper Used in Bag and Roll (EN 868-5) Production - Properties and Test Methods
Standard Scope: This part of the EN 868 series provides samples for special requirements and test methods used in the manufacture of paper bags and bags (specified in EN 868-4) and rolls (specified in EN 868-5). This chapter does not impose additional requirements on the general requirements of Chapter 1, but provides guidance based on various elements of previous, relevant national standards. The paper specified in this section defines the material to be used as packaging for medical devices to be sterilized.
 

 

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