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 |