Mixed pouch for sterilisation self-adhesive with 2 indicators, steam and ethylene oxide.
Available in several sizes, comes in boxes of 2000 units.
The self-adhesive band permits to close it without a heat sealer.
- Pouch made of two materials, one side made of paper with controlled permeability and the other side is made of polypropylene polyester.
- Heat sealed longitudinally and transversely with fluted seal, opens without tearing and without detachment in any of the two surfaces.
- With indicator inks which change colour in steam and ethylene oxide procedures, free from toxic residues in order to identify the process easily.
- Opening direction is indicated.
- Easy RESEALABLE system that allows the sealing of the pouch without heat-sealing machine.
- With print on the paper in the sealing area which totally prevents possible migration of the inks to the packaged materials.
Composition of raw materials:
|MEDICAL GRADE PAPER|
|Pure bleached cellulose high tear resistant – Controlled permeability and water resistant – Free of toxic chemicals – Resistant to sterilisation. – Effective biological barrier|
|Formed by two simple sheets.- Polyester – Polypropylene. – Approved by the F.D.A. – With high tear resistant polypropylene – With coloured film to visualise the sealing quality|
|Steam and ethylene oxide. Free of toxic residues comply with the ISO 11140-1 standard for process controls (Class 1 )|
- For individual packaging of materials to be sterilised with steam and ethylene oxide, etc.
- After steam sterilisation process, the indicator changes from PINK to BROWN.
- After ethylene oxide sterilisation, the indicator changes from BLUE to GREEN.
- The pouch must be intact after processing.
The pouches comply with the following regulations:
- DIN 58953 p. 4 (Germany)
- BS 6871 (United Kingdom).
- UNE – EN 868-5 (European Union).
- The mixed self-adhesive pouches are considered as medical devices Class 1 under R.D. 1591/2009.
Tests and regulations:
|TEST||TEST STANDARD||VALUE||PERGUT AVERAGE VALUE|
|Paper quality||EN 868-3||Pure cellulose||Complies|
|Film delamination||EN 868-5 Annex A||Exempt||Exempt|
|Micropores in the film||EN 868-5 Annex B||None||Complies|
|Film imperfections||EN 868-5||None||None|
|Resistance to film tear||ASTM 882 Method A||>20N / 15mm.||32|
|Overall width||EN 868-5 Annex C||> 6mm.||9-10|
|Process indicator||ISO 11140-1||>100mm2||400|
|Adjustment steam indicator Class-A||ISO 11140-1 (8.2)||134º C /2min.||134ºC / 2.5 min.|
|Adjustment O.E. indicator (600mg/l) Class A||ISO 11140-1 (8.4)||54ºC / 20 min.||54ºC / 30 min.|
|Chloride content||ISO 9197-1||< 0.05%||0%|
|Sulphate content||ISO 9198||< 0.25%||0.07%|
|pH of aqueous extract||ISO 6588||from 4.5 to 8||6.6|
|Tensile strength dry||ISO 1924-2||> 1.5 N/15mm.||3.25|
|Tensile strength wet||ISO 1924-2||> 1.2 N/15mm.||2.65|
|Peel test||EN 868-5 Annex C||<10 mm.||3|
|Opening direction||EN 868-5 Annex E||Indicated||Indicated|
|Resistance to sterilisation||EN 868-5 Annex A||No tear||No tear|
|Dimensions and tolerances (L , A )||EN 868-5 Annex E||– 0 ; +/- 3mm.||-0 /+2|
* The mixed self-adhesive pouches comply with the standard UNE-EN ISO 11607 parts 1 and 2 ,UNE-EN 868-5
Medical device Class 1 under R.D. 1591/2009 and CE marked.