Medical creped paper
Medical creped paper designated for packaging of sterilized products; sterilization in gravity sterilizers. Non-sterile
Sold in rollers, width 850 mm, length 200-250 meters, wight app. 10 kg.
Creped paper class 1
Rollers are packed in polyethylene bags.
Made in Lithuania, ISO 9001 Sertificate No. 15 100 9488
COMPLIES WITH REQUIREMENTS OF: ANNEX , OF EUROPE COUNCIL DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES DIRECTIVE AND REQUIREMENTS LISTED IN LITHUANIA MEDICAL NORM MN:200 „TECHNICAL REGULATION RELATING TO THE SAFETY OF MEDICAL DEVICES“ FOR MEDICAL DEVICES.
The object of the declaration described above is in conformity with the requirements of the following documents:
|Document No.||Title||Auth. no., Date of approval|
|93/42/EEC||Europe Council Directive 93/42/EEC concerning medical devices (I Annex)||14-06-1993|
|MN 4:2009||Technical regulation relating to the safety of medical devices (I Annex)||21-03-2010|
|TD 04-2:2004||Medical creped paper (Nonsterile)||04-06-2004|
|No.||Titles of Qualitative indexes||Standard Norm||Factual indexes|
|1||Contents according to fibre, % – not whitened sulphate cellulose||100||100|
|2||Grams in square meter, g/m2||55 ± 10||53|
|3||Cessation power while pulling in mechanical direction, not less than, N||13||14,7|
|4||Lengthening until cessation while pulling in mechanical direction,not less than,%||25||48|
|5||Humidity, %||7 ± 2||7,2|
NR. KT 2001 PRODUCT TECHNOLOGY CARD
Production line: PERINI
Creped medical paper
Reference sample No.KT-001