Mixed sterilisation pouch self-adhesive 2 indicators 1000 units/box
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Warnings and product safety information:
Mixed pouch for sterilisation self-adhesive with 2 indicators, steam and ethylene oxide.
Available in several sizes, comes in boxes of 1000 units.
The self-adhesive band permits to close it without a heat sealer.
Description:
- 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 |
| PLASTIC FILM |
|---|
| 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 |
| VARIABLE INK |
|---|
| Steam and ethylene oxide. Free of toxic residues comply with the ISO 11140-1 standard for process controls (Class 1 ) |
Use:
- For individual packaging of materials to be sterilised with steam and ethylene oxide, etc.
Results:
- 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.
Regulations:
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 |
| Toxicity | EN 868-5 | 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 subject to CE mark.