2018 Professional manufacturer steam sterilization reader

Product Description
2018 Professional manufacturer steam sterilization reader
EO or Steam Sterilization Biological Indicators1Product NameSelf-contained Biological Indicator2UsageMonitoring EO or Steam Sterilization Processes3Applicable RegulationsEN ISO 11138-1:2007 and EN ISO 11138-2:2009;
IRAM 37102-1:1999 and IRAM 37102-2:1999.4Product ClassificationClass 15Authorized byDesign under Quality Controls integrated systems
EN ISO 9001:2008 and EN ISO 13485:2012.6Product CharacteristicsPolypropylene random copolymer tube: 44.0 mm
high x 7.0 mm diameter. Wall thickness: 0.5 mm. PP plastic cap: 10.5 mm diameter, 13.0 mm high.
Wall thickness: 1.0 mm.Glass ampoule: 35.0 – 38.0 mm high.
Internal diameter: 5.7 – 5.9 mm.
External diameter: 6.8 mm.
Wall thickness: 0.2 – 0.3 mm.Culture medium: 0.5 – 0.7 ml, blue color.Cap paper: medical grade paper, 60 g/m2, 16.0 mm diameter.Filter Paper: 8.0 mm diameter, 160 g/m2.106 Bacillus atrophaeus ATCC 9372 spores per vial.Positive results: 48 hours (maximum). Culture medium turns to yellow, incubation at 37ºC.D-Value: EO: Not lower than 2.5 minutes, conditions:
600 ± 30 mg/l EO, 60 ± 10% RH, 54 ± 1ºC. Steam: Not lower than 1.5 minutes at 121ºC. Another D-value is estimated at 128ºC and/or 134ºC for the calculation of Z-Value
Z-Value: Not lower than 6ºC.7Environmental conditions during
manufactureRoom temperature 15-30ºC, RH 30-80%. Sterility conditions are necessary only during the
inoculation process performed in laminar flow.8Storage conditionsT=15-30ºC, RH 35-60%, keep in a dark place.9Transportation ConditionsStorage conditions should be strictly followed.
The products should be transported in closed and strengthened boxes in order to avoid damages.
Product transportation does not represent any risk
for human health.10Shelf-life24 months11PackingPacking information: Code, product description,
process in which is used, presentation (30 units or 100 units per box), classification according to regulation, batch number, expiration date and manufacturer information.12LabellingOn the product: 17.0 mm x 33.0 mm Polyester or
paper label. Printed in black. 1.5 mm chemical indicator line, printed with EO reactive ink (Color change to green), Steam reactive ink (Color change: pink to brown).
On the product’s box: batch number and expiration date.13Possible target marketsHealthcare and Industry14Other important information (optional)It is advisable to incubate at 37ºC(EO) , 60ºC(Steam) in BIonOVA INCUBATOR.
Read product’s directions for use thoroughly before use.
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