Call Us Today!

Class 5: Dental Sterilization Steam Indicator Strips Class V, 200 pcs/Box Autoclave Test Strips

Short Description:

INTEGRATING CHEMICAL INDICATORS FOR STEAM STERILIZATION CONTROL (CLASS / TYPE 5)
GENERAL INFORMATION
The instruction applies to 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 5 of ISO 11140-1-2014 in steam sterilizer chambers with all method for removing air from sterilization chamber.

INDICATIONS FOR USE
Indicators should be used for routine and periodic monitoring sterilization of medical devices in sterilization departments of medical preventive organizations are intended for use by personnel of organizations, institutions and services that operate and control sterilization equipment.


Product Detail

Product Tags

CONTRAINDICATIONS FOR USE
DO NOT use indicators that have expired.
DO NOT use damaged indicators.
DO NOT use indicators with wet or wet sterilized products.
It is not allowed to place the indicator on the wall / door of the sterilization chamber.

POSSIBLE SIDE EFFECTS WHEN USING
If used correctly, stored and transported in accordance with these instructions, there are no side effects.

PURPOSE AND SCOPE OF THE MEDICAL DEVICE
Integrating sterilization control indicators, chemical disposable MEDIWISH, are designed for operational visual control of compliance with critical variables of the steam sterilization process - sterilization temperature, sterilization holding time and the presence of saturated water vapor, inside sterilized medical devices and sterilization packages with products during their sterilization under any permitted sterilization modes in steam sterilizers of any type.

MAIN TECHNICAL CHARACTERISTICS
The indicators correspond to class 5 (integrating indicators) according to the ISO11140-1 classification.
Indicators are rectangular paper strips with two color marks applied on one side (indicator and violet comparison element). The initial color of the indicator mark irreversibly changes depending on the achieved values ​​of the critical sterilization parameters during the steam sterilization cycle. The violet comparison element shows the final color of the indicator mark if the required values ​​of the critical parameters are met.
Indicators can also be manufactured with a sticky layer on the back of the indicator, covered with protective paper, separated by a notch for easy fixing of the indicator and its documentation.
The indicator is applicable in steam sterilizers of any type and in any modes of steam sterilization in the range from 110 ° C to 135 ° C. The control values ​​of the indicators are shown in Table 1.

Guaranteed conditions for the sterilization indicator to reach the final state under regulatory conditions

Indicator name

Indicator dot color (before/after sterilization)

Product code

Control stated value(s) for the indicator (SV)

Temperature (C)

Time

(min)

Integrating sterilization indicator MEDIWISH, class 5

Yellow-blue

50.100

121

126

132

135

18

11

5.5

4

To the attention of professional consumers!

3.4 Dry heat test. Sensitive thermal indicator composition of indicators for control steam sterilization process, in accordance with the requirements of clause 13.4. ISO 11140-1-2014 tested at reference values of temperature140 °C ± 2 °C and time for 30 min ± 1 min, and not reach the end point. The dry heat test is intended to ensure that simulators for the control of sterilization processes reach their end point only in steam.

4. 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*

 

  • The chemical reaction which causes the color transition is a steam specific reaction and is irreversible.

5. PERFORMANCE CHARACTERISTICS

Result Availability Color change to signal after reaching sterilization parameters

Unexposed*

Exposed to Steam 134°C, 3.5 minutes*

 image2

 image3
ico2

NOTES:

The blue shades of the sterilization indicator comparison item of different batches may have slight differences within the printing error.
2. Depending on the characteristics of lighting (illumination, natural or artificial, type of lamps, etc.) the final blue color of the indicator mark can have various shades of blue.

6. CONTRAINDICATIONS FOR USE.
Contraindications to the use of indicators of the sterilization process are:
6.1. Non-compliance of indicators with the requirement stated in clause 3.4. of this manual;
6.2. The use of indicators to control the sterilization of liquid medicines and other products in sealed vessels;
6.3. Use of indicators by personnel who have not been instructed in this manual.
7. PREPARING INDICATORS FOR WORK.
7.1. Before placing the indicator and the product to be sterilized inside the sterilization package, inspect the package, check the appearance, integrity, compatibility of the material of the pouches, package, sterilization container (box)
7.2. Clean, dry products to be sterilized, previously subjected to sterilization cleaning, are placed in sterilization pouches, packaging, sterilization containers (boxes).
8. PROCEDURE FOR WORKING WITH THE INDICATOR.
8.1. The quantity of sterilization indicators (5-13 pieces) placed inside the packages depends on the volume of the sterilization chamber, the number of sterilization containers (boxes), sterilization pouches, packages with sterilized products.
At least one indicator is put into each sterilization pouch.
9. ORDER OF APPLICATION OF INDICATORS
Indicators are used with every sterilization cycle. Indicators are used to control the parameters of the sterilization cycle in the sterilizer chamber, placing both inside the sterilized packages with products and outside the sterilized packages.
9.1. The procedure for using indicators when monitoring the parameters of the sterilization cycle (laying outside the packages by control points). The number of indicators installed in the sterilizer depends on the volume of the sterilizer chamber (Table 2, Fig. 1).
Table 2 - The number of indicators placed in the sterilizer, depending on the volume of the sterilizer chamber

Steam sterilizer chamber volume, liters

The number of points to which indicators are laid

up to 100 inclusive

5

over 100 - up to 750 inclusive

11

over 750

13

image5

Indicators are placed at all test points in the sterilization chamber on the outside of the packages or sterilization boxes. Indicators are numbered in accordance with the numbering of control points (Fig. 1) and placed in the sterilizer chamber, adhering to the location of the control points (Fig. 1). At least one indicator is placed at each point, fixing it with an adhesive layer. To do this, the indicator is bent along the notch, the sticky layer is released by removing one half of the protective paper, and glued to the control point.
Fixing the indicators to carry out:
- when using combined packages (transparent synthetic film with paper) - on the film;
- when using gusset paper pouch - on the sealing valve of the pouch;
- when using sheet paper wrapping materials - on the corner of the paper that remains free after wrapping;
- when using sterilization containers (boxes) - on the container tag.
At the end of the sterilization cycle, assess the color change of the indicator mark of each indicator. If the color of the indicator mark on all indicators changed to the final color corresponding to the color of the comparison element, or became darker (up to black), then the required values ​​of the critical variables of the sterilization process were observed. If the indicator mark of at least one indicator is lighter than the color of the comparison element or has a different color, then the required sterilization conditions in the sterilizer chamber have not been met. Consequently, all load items are considered non-sterile and must be re-sterilized. In this case, the observance of the rules for loading the sterilizer and the correct setting of the sterilization mode parameters are checked, the products are repackaged in a new package, the indicators are replaced, and the products are re-sterilized.

ico2

NOTES:

1. During the sterilization cycle, slight deformation of the indicators is possible, which does not affect the control results. If the indicator mark of at least one indicator has completely or partially retained the yellow color, easily distinguishable from the color of the comparison element, then the conditions for effective sterilization were not met, all medical devices from this load are considered non-sterile.
If unsatisfactory control results are repeated, the operation of the sterilizer is stopped and its technical serviceability is checked. Operation of the sterilizer is resumed after elimination of the causes and positive results of the sterilization chamber tightness control using a vacuum test, the microbiological sterilization efficiency using biological indicators, and vapor permeability control using a Mediwish Bowie-Dick test pack or Mediwish Helix test, chamber tightness using a vacuum test according to EN 285.
Placement of indicators inside the packages.
Indicators are placed in hard-to-sterilize places of sterilized products:
in products with a uniform porous load (sheets, clothing, gauze, etc.) - in the middle of the porous product;
in products with internal cavities (vessels, tubular products, gloves, etc.) - inside the cavities;
in products made of vapor-proof materials (polymer films, oilcloth, etc.)
- between folds or layers of products.

image6

Fig. 2. Top view of the sterilization container. The layout of the indicators in the sterilization container (box) with specific and purposeful insertions (a), with sectoral insertion (b) of medical devices.
At least one indicator is placed in individual packaging with products that are difficult to sterilize (disposable sterilization pouches and sterilization rolls).
At least three indicators are placed in the sterilization container (box) with a specific and purposeful placement of products that are difficult to sterilize: one in the middle of the product in the center of the sterilization container (box) and two in the middle of the products located at the walls (Fig. 2, a), and at least one in each sector in the middle of a difficult-to-sterilize product with a sectoral laying of products (Fig. 2, b).
Removal of the indicator from packages and sterilized products, accounting, interpretation of control results and documentation is carried out by personnel who open the packaging and prepare sterilized products for use. The conclusion about the intended use of products is carried out after removing the indicators and comparing the color of the indicator mark with the color of the comparison element.
Upon receipt of unsatisfactory control results, the information is immediately communicated to the senior personnel of the sterilization department. In this case, the observance of the rules for loading the sterilizer and the correctness of setting the parameters of the sterilization mode are checked.
If unsatisfactory control results are repeated, the operation of the sterilizer is stopped and its technical serviceability is checked. Operation of the sterilizer is resumed after elimination of the causes and positive results of the sterilization chamber tightness control using a vacuum test, the microbiological sterilization efficiency using biological indicators, and vapor permeability control using a Mediwish Bowie-Dick test pack or Mediwish Helix test, chamber tightness using a vacuum test according to EN 285.
10. STORAGE, DOCUMENTATION AND DISPOSAL.
The consumer box packaging of the indicators contains the following: product name; a short designation of the sterilization cycles for which the indicator is intended; the logo of the manufacturer or importer; framed inscription with the word "STEAM"; date of manufacture; LOT number; number of indicators;
The indicators should be stored in the manufacturer's packaging at temperatures from +5 ° C to +40 ° C and relative humidity not higher than 80% at 25 ° C, in a place protected from sunlight. Avoid moisture and direct sunlight on packaging and indicator label.
11. SHELF LIFE.
The guaranteed shelf life, subject to storage conditions, is 5 years.

ico2

NOTES:

Keep away from sterilants. Do not used damaged Indicators or Indicators which have change initial color. Do not use after expiration date
The documentation of the results of the chemical control of sterilization must be registered in the Sterilizer Operation Control Log with a record in the appropriate columns of information for each sterilization cycle. Indicators confirming the control results are glued to the appropriate column of chemical control and stored as an archive document for at least 24 months.

image7

Indicators, including used ones, do not have a harmful effect on humans and the environment, do not require special safety measures and can be disposed of as class “A” safe medical waste.

image8

12. MANUFACTURER’S WARRANTY.

12.1. The warranty period for the indicators is 5 years from the date of manufacture.
12.2. The indicators do not emit substances that are hazardous to the health of personnel or that violate the properties of the substances to be sterilized before, during and / or / after sterilization. Non-toxic, do not contain compounds of lead and other heavy metals (Mercury, Lead, Arsenic, Cadmium, Bismuth, Copper, Nickel, Antimony, Thali, Cobalt, Manganese, Chromium, etc.) and their sulfides
12.3. The final states of indicators exposed to sterilizing agents during sterilization cycles are retained when stored as an archival document for at least 24 months from the date of sterilization.
13. Compliance
ISO 11140-1:2014 Sterilization of health care products – Chemical indicators - Part 1: General requirements
14. PRODUCT CODE FOR ORDERING:
Product code Indicator name Indicator dot color (before/after sterilization)
50.100 Integrating sterilization indicator MEDIWISH, class 5 Yellow-blue
Upon request the possible variety:
laminated adhesive backside: (the letter “A” is added to the product code, for example 50.100A)

15. MANUFACTURING ORGANIZATION, SERVICE CONSULTING CENTERS:
MEDIWISH CO.,LTD
TIANHE ROAD 336, LUYANG INDUSTRIAL ZONE, HEFEI, ANHUI, CHINA
| T 0551.6555.70.89 | E info@mediwish.com | www.mediwish.com
SUNGO Europe B.V.
Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

This IFU (Instruction for use) contains information in an amount sufficient for the effective and safe use of sterilization indicators by the staff of the medical institutions for which it is intended.


  • Previous:
  • Next:

  • Write your message here and send it to us