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 PRODUKTO TECHNOLOGINĖ KORTELĖ
Gamybos linija: PERINI
Krepuotas medicininis popierius
Etaloninis pavyzdys Nr.KT-001
ĮST 110012450-42:2005
TR16
Roller |
Packaging | |||||
| Characteristic | Value | Tolerance | dimension | Roll marking | Self-adhesive label | |
| Diameter | 250 | ± 13 | mm | Bar code labeling | – | |
| Width | 730 | ± 3 | mm | Package dimensions | ||
| Nozzle diameter | 60 | – | mm | width: | 250 mm | |
| Leaf dimensions | – | – | mm | length: | 500 mm | |
| Number of sheets | 794 | ± 40 | unit | height: | 730 mm | |
| Paper length | 250 | ± 13 | m | The number of rolls of the pack | 2 unit | |
| Number of layers | 1 | – | unit | Packaging film type | bag | |
| Adhesion layers | – | Overall dimensions of the bag | 360x65x1200 mm | |||
| Indentation | – | Package labeling code |  |
|||
| Paper grammage | 55 | ± 3 | g/m² | |||
| Paper-based type | unbleached cellulose | |||||
| Perforation step | produced without perforations | |||||
| Roll weight | 10037,5 | ± 502 | g | |||
| Roll weight and nozzle | 10101,5 | ± 502 | g | |||
| Palletizing on pallets |  |
|
| The number of bags in a row | 12 unit | |
| Order on the pallet dimensions (theoretical) | ||
| length: | 1400 mm | |
| height: | 730 mm | |
| width: | 1000 mm | |
| The number of rows on the pallet | 4 | |
| The number of bags on the pallet | 48 | |
| Remarks: | ||