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Form Ref. ST-69100/69110 Rev.: A2Date: 14 May 2010

Wipak OyMedical Division Phone +358-(0)20-510 311 Fax +358-(0)20-510 3333E-Mail steriking@wipak.comWebsites www.wipak.com www.steriking.info

The STERIKING Crepe Paper wraps are water repellent creped medical special paper sheets

manufactured from bleached, virgin wood pulp.

The STERIKING Crepe Papers are developed for use as a wrap for sterile packs of surgicaldressings and instruments intended for steam, EO gas and irradiation sterilization. They can be usedas an inner or outer wrap as well as in combination with non-woven and textile materials. They arefor single use only.

Conformity to International Standards

The STERIKING Crepe Papers conform to theinternational product standards and norms: ISO11607-1:2006 and EN 868-2:2009.

The products are registered under Class 1 as

accessories in compliance with the EuropeanMedical Device Directive 93/42/EEC and itsamendment 2007/47/EC. To show compliance

with MDD the CE mark is printed on the label ofthe transport carton.

STERIKING sterilization packing materials aredesigned, validated and manufactured to suit

their intended purposes. They aremanufactured under ISO 9001 certification.

Technical Data

Storage Recommendations & Shelf Life

No special precautions need to be taken in respect ofstorage or transportation of STERIKING paper wraps.

However, they should not be exposed to very high humidityor to direct sunlight.

The shelf life is event-related and not time-related. If storedaccording to the instructions the shelf life of STERIKINGpaper wraps is at least 5 years from the date ofmanufacture.

STERIKING

Crepe Papers

Properties Units Standards or Methods Typical Value

Substance g/m ISO 536 60

Tensile strength MD kN/m EN ISO 1924-2 2.07

Tensile strength CD kN/m EN ISO 1924-2 1.63

Wet tensile strength MD kN/m ISO 3781 0.90

Wet tensile strength CD kN/m ISO 3781 0.63

Stretch MD % EN ISO 1924-2 12.0

Stretch CD % EN ISO 1924-2 5.8

Tearing strength MD mN EN 21974 800

Tearing strength CD mN EN 21974 1000

Burst strength kPa EN ISO 2758 160

Water repellency S EN 868-2 (app. D) 26

Bendtsen porosity (2 sheets) ml/mm ISO 5636-3 1750

PH of aqueous extract ISO 6588 7

Sulfate content % ISO 9198 0.018

Chloride content % ISO 9197-1 0.015

Microbial barrier DIN 58953-6 Conform

Fluorescence % DIN 58953-6 Nil

Pore Size m EN 868-2 (app. C) 29

Wet burst kPa ISO 3689 65

Resistivity Ohm BS 6524 1.6x10e11

Colors available White and Green

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Restrictions in Use

STERIKING Crepe Papers are not suitable for sterilization

by hot, dry air or plasma gas.

Sales and Transport Packing

STERIKING creped paper wraps are packed inrecyclable, brown hard carton cases. As an inner coveragainst moist and dust the sheets are wrapped in arecyclable polyethylene sheet.

Please refer to the local/national regulations regardingwaste disposal.

Labelling: Each case bears a label with the necessaryinformation/instructions of the content in according with ISO11607-1:2006 & EN 868-2:2009.

In Case of Complaint

In event of any complaint, the lot number and identificationcode must be provided by the complainant. For evaluationof claimed product, a defective sample (or a digital photo)and description of the defect together with an unusedspecimen must be made available to Wipak.

STERIKING is a registered trademark of Wipak Medical.

Steriking SPC Crepe Papers

This specification refers to the named product group and shall be valid until the next revision. Other product related documentsmay be available upon request.

The information contained here is to our knowledge accurate and reliable as of the date of the publication. Wipak extends nowarranties and makes no representations as to the accuracy or completeness of the information contained herein, andassumes no responsibility regarding the consequences of its use or for any printing errors. It is the customers responsibility toinspect and test our products in order to satisfy himself as to the suitability of the products for the customers particularpurpose and suitability to the actual circumstances the product is exposed to. The customer is also responsible for theappropriate, safe and legal use, processing and handling of our products especially when recommendations for safe use andstorage are given. Nothing herein shall constitute any warranty, nor is a protection from any law or patent to be inferred.

Code Size

(cm)

Sales Packing

(Sheets/Case)

SPC40 40x40 500

SPC50 50x50 500

SPC60 60x60 500

SPC75 75x75 250

SPC90 90x90 250

SPC100 100x100 250

SPC120 120x120 100

SPC140 100x140 100