Gas plasma sterilization indicator
PURPOSE
The plasma sterilization indicator is designed to monitor conditions in all modes (accelerated, standard, enhanced) at a temperature of 27-60 ° C. It is recommended to use indicators in every sterilization cycle. Indicators provide documentation of sterilization control with the safety of control results as an archive document for at least 12 months. The indicators are intended for use by personnel of institutions, enterprises and services that operate and control sterilization equipment, for the prevention of diseases and nosocomial infections due to the incorrect operation of sterilizers.
INDICATIONS FOR USE
The use of indicators allows timely detection of possible violations of the parameters of the sterilization cycle modes, such as:- failure of parameters of sterilization exposure,- violation of the rules and norms for loading the sterilization chamber,- poor penetration of the sterilizing agent into the packaging or the product to be sterilized,- under estimation of the concentration of hydrogen peroxide vapors in the sterilization chamber.
MAIN TECHNICAL CHARACTERISTICS
Depending on the potential risk of use, the indicators are classified as class 1 medical devices.
Indicators are rectangular shape with indicator marks applied on them, a comparison element and markings including: the manufacturer's logo; indicator name; indicator class; abbreviated designation of the sterilization method ("H2O2"); sterilization modes.
If the sterilization conditions are met, the initial color of the indicator mark irreversibly changes to the final color corresponding to the color of the comparison element. If the sterilization conditions are violated, the color of the indicator mark does not change. Plasma sterilization modes (sterilization with hydrogen peroxide vapor) for which the indicators are intended, control values, the color of the indicator comparison element are shown below:
Physical Properties
| Process | Steam |
| Dimensions | 26 mm x 67 mmThickness: 0.10 mm (indicator); 0.17 mm (indicator and liner) |
| Packaging | 250 Indicators/box |
| Chemical Indicator | Initial Color:·Magenta Signal Color:Yellow |
Intended Use
Class 4 / Type 4 plasma sterilization
Temp-50°C, Time 6 minutes, concentration of hydrogen peroxide, mg /L-2.3 mg/L
Instructions for Use
Use an indicator on each item, pack, peel pouch, or tray that will be steam sterilized. Place at a location considered most challenging for plasma gas to reach. Process packages/items as instructed in the autoclave/sterilizer validation or manual.
Placement of indicators outside the packages:- when using combined packages - on the film; when using bags - on the sealing valve of the bag;- when using sheet wrapping materials - on the corner of the paper that remains free after wrapping; when using sterilization boxes - on the box tag.
Placement of indicators inside the packages. When placing indicators in sterilization packaging, place indicators:- when using Tyvek® packs and bags inside the bag;- when using sterilization boxes - under the box lid.
If the sterilization conditions are met, the initial color of the indicator mark irreversibly changes to the final color corresponding to the color of the comparison element. If the sterilization conditions are violated, the color of the indicator mark does not change.
The chemical reaction which causes the color transition is a hydrogen peroxide vapor specific reaction and is irreversible.
| Result Availability | Color change to signal after reaching sterilization parameters |
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Unexposed* |
Exposed to Steam 134°C, 3.5 minutes* |
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olors shown are representations of printed ink initial and signal colors but may vary from actual use.
NOTES:1. Slight non-uniformity of the color of the indicator mark is allowed within the printing error.2. The color of the final state of the indicator mark may slightly differ from the color of the comparison element in hue and intensity.The indicator mark does not penetrate the substrate, does not leave traces and does not transfer to the material with which the indicator comes into contact
before, during and after the corresponding sterilization regime.
Compliance
ISO 11140-1:2014 Sterilization of health care products – Chemical indicators - Part 1: General requirements
Storage and Shelf Life
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15°C to 30°C |  |
Keep away from sunlight |
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20% to 70% relative humidity |  |
Keep dry |
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Shelf life |
5 years from the date of manufactureThe date of manufacture is based on the day the indicating ink is applied to the substrate. The remaining shelf life upon receipt will be shorter than 5 years | ||
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Keep away from sterilants. Do not used damaged Indicators or Indicators which have transitioned to yellow. Do not use after expiration date | ||
Disposal
Discard as general waste. Product code for ordering -70.100
Produced under the trademarks: MEDIWISH®, FUTURE CARE®