Type 6 Emulating Indicator
GENERAL INFORMATION
Emulating Indicators class 6 (according ISO 11140-1) disposable chemical indicators for monitoring steam sterilization processes manufactured by Mediwish Co., Ltd, designed to ensure operational visual control of compliance with the parameters of modes and conditions of steam sterilization according to class 6 of ISO 11140-1-2014 in steam sterilizer chambers with a fore-vacuum method for removing air from sterilization chamber. Class 6 indicators are especially necessary when monitoring the sterilization of materials and medical devices on not new equipment, when using instruments during extensive operations, in particular, in transplantology, during operations in immunocompetent patients, in oncology and burn departments, in AIDS patients and others cases where absolute quality assurance of sterilization is required with a Sterility Assurance Level (SAL) of ≥10-6
They fulfill the requirements for Type 6 indicators monitoring all the critical parameters of the sterilization process at their position in the autoclave chamber and ensuring an adequate control of the effectiveness of the sterilization processes (temperature, time, steam quality). The wide range of emulators allows the selection of the most suitable indicator for the sterilization process to be controlled, since they are cycle-specific indicators.
PRODUCT DESCRIPTION
Mediwish Emulating chemical indicator, type 6 is performing very precisely for color-change in accordance with such three parameters as time, steam, and temperature covering 121ºC 15 min. 135ºC 3.5 min. up to 141º C. The color- sharp change is from yellow to blue or pink to violet. Indicator enables to estimate aseptic guarantee level: by presuming the exposure condition of saturated vapor under measurement of precise sharp color-difference. Delicate color-difference on plastic film laminated appears precisely as follows in accordance with all critical parameters. Standard version is a laminated indicator without an adhesive backside.
Class 6 indicator strips were developed with Mediwish® innovative chemical technology, 100% metals free, and tested with stringent quality standards according ISO 11140-1.
INTENDED USE
The indicator is intended for professional users-personnel of medical institutions, workers of disinfection and sanitary-epidemiological services, as well as other organizations and institutions entitled to carry out disinfection activities during operational visual control of the parameters of modes and conditions of steam sterilization in sterilizers with a fore-vacuum method for removing air from the sterilization chamber that meet the requirements EN 285 “Steam large sterilizers. General technical requirements and test methods”; EN 13060 “Small steam Sterilizers”. Indicators allow you to identify deviations from all critical variables (sterilization temperature, sterilization holding time, the presence of saturated water vapor) in the tolerances of critical variables according to class 6 of ISO11140-1-2014, caused by:
-the presence of air inside the sterilized pouches, packages;
-insufficient duration of the air removal phase, lack of tightness (air leakage) of the sterilizer in the air removal phase by evacuation;
-inhomogeneity of the parameters of the supplied steam or its discrepancy (fluid, dry, overheated);
-improper configuration or loading volume;
-an error in setting the autoclave parameters of the sterilization mode or their failure
MAIN TECHNICAL CHARACTERISTICS.
Indicators are a paper carrier with lamination and applied color thermal indicator (in the initial state) and color(signal state) marks, marking according to ISO 11140-1-2014. Until the specified conditions are reached, the color ofthe indicator mark remains the original, when the specified conditions are reached, it sharply,abruptly changes to the signal one.
The outer surface of the indicators is protected (by the separating membrane method) with a copolymer that allows the components of vapor-gas mixtures to pass through and prevents direct contact of the indicator mark with the products.
The indicator mark does not penetrate the substrate and does not leave marks on the material with which the indicator comes into contact before, during and after the respective sterilization cycle.
The principle of operation of indicators for monitoring sterilization processes is based on an irreversible contrast change in the color of the thermal indicator mark of an indicator that has undergone a steam sterilization cycle.
Advantages
• Clear instructions and easy to read results.
• Immediate and accurate verification of load exposure to correct parameters of sterilization (time, temperature and steam).
• Manufactured with Mediwish® inks,100% Heavy Toxic Metals Free.
Emulating Indicator incorporates the unique Mediwish® ink technology. Lead free and non-toxic, this ink is safe to use and environmentally friendly.
• Highly sensitive and accurate.
PHYSICAL PROPERTIES
| Process | Steam |
| Dimensions | 26 mm x 67 mm; Thickness: 0.10 mm (indicator); 0.35 mm (indicator and liner) |
| Packaging | 250 Indicators/box |
| Chemical Indicator* | Initial Color: Yellow Signal Color: Blue*
Initial Color: Pink Signal Color: Purple* |
- · The chemical reaction which causes the color transition is a steam specific reaction and is irreversible.
| PERFORMANCE CHARACTERISTICS | |
| Result Availability
|
Color change to signal after reaching sterilization parameters |
|
Unexposed* |
Exposed to Steam 134°C, 3.5 minutes* |
| Unexposed* | Exposed to Steam 134°C, 3.5 minutes* |
Sterilization - TST Class 6 Emulating Indicators
|
REF: |
Indicator name |
Indicator dot color (before/after sterilization) |
Quantity |
|
60.100 |
Emulating sterilization indicator 134°С/3.5 min//121°С/15 min, class 6 |
Yellow-blue |
250 Indicators |
|
60.110 |
Emulating sterilization indicator 134°С/3.5 min//121°С/15 min, class 6 |
Pink-violet |
250 Indicators |
|
60.101 |
Emulating sterilization indicator 134°С/4 min//121°С/20 min, class 6 |
Yellow-blue |
250 Indicators |
|
60.111 |
Emulating sterilization indicator 134°С/4 min//121°С/20 min, class 6 |
Pink-violet |
250 Indicators |
|
60.102 |
Emulating sterilization indicator 134°С/5 min, class 6 |
Yellow-blue |
250 Indicators |
|
60.112 |
Emulating sterilization indicator 134°С/5 min, class 6 |
Pink-violet |
250 Indicators |
|
60.103 |
Emulating sterilization indicator 134°С/7 min, class 6 |
Yellow-blue |
250 Indicators |
|
60.113 |
Emulating sterilization indicator 134°С/7 min, class 6 |
Pink-violet |
250 Indicators |
|
60.104 |
Emulating sterilization indicator 134°С/10 min, class 6 |
Yellow-blue |
250 Indicators |
|
60.114 |
Emulating sterilization indicator 134°С/10 min, class 6 |
Pink-violet |
250 Indicators |
|
60.105 |
Emulating sterilization indicator 134°С/18 min, class 6 for PRION cycle |
Yellow-blue |
250 Indicators |
|
60.115 |
Emulating sterilization indicator 134°С/18 min, class 6 use in PRION cycle |
Pink-violet |
250 Indicators |
Single and double strips
MEDIWISH steam sterilization process internal indicators to be used inside the sterilization package. Indicators are designed to demonstrate that the package has been exposed to Steam. They are designed for use in steam autoclaves operating at 121°C/1 bar or 134°C/2 bar.
The indicators change color from yellow to dark brown. By using steam indicators, autoclaved products can be distinguished from non-autoclaved products. These indicators can be delivered from stock. Class 1, according ISO11140-1 standard
Self-adhesive tapes have been designed to wrap and seal sterilization packages as well as to distinguish between items that have been exposed to Steam sterilization processes from those that have not.
These devices are manufactured in compliance with ISO 11140-1 Standard.
Self-adhesive tapes and labels show a color change when exposed to the sterilizing agent.CD21/CD27/CD227/CD228 are commonly placed out of the plate, package or pouch, thereby, products that were processed can be distinguished from unprocessed at a glance. These indicators ensure that the plate, package or pouch has been exposed to a certain process.
Advantages
• It can be adhered to different types of wrap like fabric, paper and plastic.
• Manufactured with high quality materials, it offers resistance to physical and chemical damage produced by sterilization processes.
• Easily removable, leaves no residues.
• Allows writing on their surface, facilitating load traceability.
• Significant color change allows straightforward differentiation between exposed packages from those unexposed.
• Manufactured with Mediwish® inks, 100% Metals Free.
Automatic record system labels are printed with Mediwish® Type 1 indicator ink, 100% metals free. CD203 are simple self-adhesive labels while CD23 and CD28 are double self-adhesive labels. Double self-adhesive technology allows easy label removal from the sterilization package for data documentation. CD23 and CD203 are to be used with Mediwish® CG3 manual labelling device, which has three printing lines, each one consisting of 12 digits and alphanumeric coding. These indicators are manufactured in compliance with ISO 11140-1 Standard.
Advantages
• Allows traceability of the sterilization process information.
• Eliminates errors in batch number record.
• Easy interpretation of results due to Type 1 indicator accurate change in color.
• Easy removal and re-adherence due to double self-adhesive technology of the Mediwish® automatic record system.
• Quick labeling when using an automatic labelling device.
• Very low-cost.
Mediwish® CD20, CD25, CD29, CD29-AD and CD202 Type 4 internal control strips as well as
CD201 cards, are multi-variable indicators that rapidly show if critical parameters of the Steam sterilization process have been reached, besides ensuring appropriate Steam penetration of the items inside the packages.
These devices are manufactured in compliance with ISO 11140-1 Standard.
Advantages
• Allows traceability of the sterilization process information.
• Eliminates errors in batch number record.
• Easy interpretation of results due to Type 1 indicator accurate change in color.
• Easy removal and re-adherence due to double self-adhesive technology of the Mediwish® automatic record system.
• Quick labeling when using an automatic labelling device.
• Very low-cost.
Mediwish® Three-level Sequential Integrating Indicators designed to react inside loads exposed to Steam sterilization processes. The Integration level consists of a blue ink developed to turn to black when a theoretical population of spores reaches its kill time, indicating that the SAFE condition is achieved.
Level 1 - Process: Exposure level, it turns to black to indicate the exposure to the process but it does not assure that the conditions indicated in the integrator have been met (UNSAFE condition).
Level 2 - Correct: Integration level, it turns to black thus indicating that conditions indicated in the integrator have been met. These conditions are calibrated with the kill time of a 106 theoretical Geobacillus stearothermophilus spore population, calculated in a BIER (Biological Indicator Evaluator Resistometer). This is called SAFE condition.
Level 3 - Extended: Over-integration level, turns to black when integration conditions indicated in the product have been overreached. This is called EXTENDED condition.
Advantages
• Allows traceability of the sterilization process information.
• Eliminates errors in batch number record.
• Easy interpretation of results due to Type 1 indicator accurate change in color.
• Easy removal and re-adherence due to double self-adhesive technology of the Mediwish® automatic record system.
• Quick labeling when using an automatic labelling device.
• Very low-cost.
Mediwish® Bowie & Dick Test Pack was developed to control air removal and steam penetration performance in vacuum-assisted steam sterilizers. Mediwish® Bowie & Dick Test Packs are single-use devices that consist of a lead-free chemical indicator, BD Test Sheet, placed between porous sheets of paper, wrapped with crepe paper, with a Steam indicator label on the top of the package. Product BD125X/1 also has a Warning Sheet which contains a circular lead- free chemical indicator, and is placed in the pack at a lower point than the BD test sheet, thus allowing an early detection of air removal failures before they appear on the central chemical indicator. If the circle does not turn to a uniform black color, this is evidence of an imminent failure in the sterilizer, indicating that maintenance should be scheduled.
A uniform and complete color change on the BD Test Sheet indicates adequate air removal and steam penetration. A failure in air removal, poor quality steam, superheated steam and/ or non-condensable gases in steam supply are evidenced as a non-uniform color change in some areas of BD Test Sheet.
Bowie & Dick Test Pack are manufactured under ISO 11140 (Parts 1, 4 and 5) International Standards and elaborated under the Quality Management Systems ISO 13485 and ISO 9001.
Useful tips
• Bowie & Dick Test Pack should be used on a daily basis, every time the sterilizer is put into operation, before the first cycle and the first load to be sterilized. Start a shortened cycle (eg. omitting the phase of post-vacuum drying) to adequately heat up the sterilizer.
• Bowie-Dick Test Packs should be used daily; after a sterilizer is installed or relocated; after a sterilizer malfunction; after sterilization process failures; and after major repairs of the sterilizer.
• Place the Bowie & Dick Test Pack horizontally with the chemical label facing up inside an empty chamber, on the bottom shelf or at the front of the sterilizer support and over the drain.
| Name: | Autoclave Sterilization indicator BD bowie dick test pack for steam sterilization |
| Model: | MZS2018 |
| Size: | 115x125 mm |
| Material: | steam penetration (air removal) barriers in the center |
| Color: | Initial color Yellow change to Brown, blue to brown |
| Packing: | 1pc/bag,50pcs/carton, 28x27x24cm |
| Features: | Bowie and dick test pack offered by us are single use test packs that allow users to successfully perform daily Bowie & Dick test in an effective & simple way. The advantages of single use test pack is that it is absolute safe in handling & reproducible in results. It consists of a series of steam penetration (air removal) barriers in the center of which is a chemical indicator sheet. Used for daily monitoring of pre-vacuum steam sterilizer. The Bowie Dick pack makes the operator a right control of the autoclave and verify possible defects during Bowie Dick's cycle. Bowie-Dick test packs should be used daily, especially after a sterilizer is installed, relocated, after sterilizer malfunction, after sterilization process failures, and after any major repairs of the sterilizer. Single use Bowie Dick pack is characterized by most reliable test such as: 1. Point out the presence of air leaks in the autoclave immediately and accurately; 2. Nontoxic ink and completely recycled materials; 3. Color Change: yellow to brown These products are CE marked and meet the requirements of EN 867 and ISO 11140-1; Operation Condition: 134℃, 3.5 minutes; 120℃, 15 minutes |
| Certificate: | CE/ISO 13485 |
"PCD Helix test MEDIWISH" is a reusable device made of a polymer tube and a plastic container with an internal cavity and includes one-time test strips for each test cycle. Used to control the serviceability of steam sterilizers with forced forvacuum removal in the test cycle: 134 C / 2 min, 121 C / 10 min in an empty sterilization chamber.
Product Features:
Indicator 2 classes (for special tests) according to ISO 11140-1; Complies with EN 13060 (Classified as a hollow product of type A) and EN 867-5; The result of the test is easily interpreted; A sticky layer on the test strip facilitates documentation; A clear color transition from the initial yellow to the final dark brown; The device is reusable, it is designed for 200 tests; Non-toxic, does not contain lead compounds, does not emit harmful and toxic components during application and storage; The warranty period is 36 months. Test of "PCD Helix test MEDIWISH" allows timely detection of unsatisfactory removal of air from the sterilization chamber, caused by such reasons as: Leakage of the sterilization chamber;
Failure of the fore-vacuum pump;
Faulty valves; Insufficient multiplicity of air evacuation from the chamber.