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  /    /  Autoklaver och sterilisering, Steriliseringsmaterial, Steriliseringspåsar och rullar  /  Steriliseringspåsar med 2 indikatorer, mix i låda med 2000 st 90 x 203 mm

Steriliseringspåsar med 2 indikatorer, mix i låda med 2000 st 90 x 203 mm

2780 kr2960 kr

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Product description

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.

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 CE marked.

 

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