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Indicator, TST control, spot, adhesive - 1000453

Product ID: ITM-1000453
generic
GENERAL DESCRIPTION
Indicator TST (Temperature, Steam, Time) control spot for steam sterilization process, type (class) 6 indicator, pack of 300.

INTENDED USE
A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/of physical change to one of more of the physical conditions within the chamber, to validate the sterilization process. This is a single-use device.

TECHNICAL SPECIFICATIONS
Steam cycle verification indicator; TST indicators (Time, Steam and Temperature).
Model: Type (class) 6 Emulating Indicator (cycle verification).
The indicator shall be marked with the type (class) of process it is intended for.
The indicator shall be marked with "STEAM".
The control spot should irreversibly change colour after exposure to saturated steam with a temperature of 121° Celsius for a minimum period of 15 minutes.
The indicator shall indicate the time required (15 minutes) for discoloration at 121° Celsius.
The indicator shall have an adhesive back.
Suitable for use in portable steam sterilizers of the pressure cooker type, 24 and 39 Litres.

SUPPLIED WITH
Instructions for use in English, French and Spanish.
1 x record sheet.

SHELF LIFE
4 years

ENVIRONMENTAL CONDITIONS
Storage conditions: 0 - 30°C / 30% - 60% RH.
Operating conditions: 0 - 30°C / 30% - 60% RH.
Store in a cool dark place, away from direct sunlight.
Check before use. Do not use TST spot if the colour is not YELLOW.
Monitor shelf life (batch (lot) number and expired date)
Important: It is recommended to follow Manufacturer's instructions for use.

WEIGHT AND VOLUME (Packaged) - estimated
Weight: 45 gr.
Volume: 0.1 dm³.

Instructions for use:
The use of TST control spot gives an immediate indication to the person in charge on successful sterilisation cycle of not.
TST control spot must be used systematically for each steam sterilization cycle.
TST control spot must be attached to the lid of drum (of other steam sterilizing container), TST control spot must be checked when the sterilizing cycle is finished.
TST control spots are delivered with 1 record sheet to retain 300 TST control spots and to be used to record the results of all sterilizing cycles, pass of fail, remedial action taken to remedy failed cycles.
If the TST control spot has changed from YELLOW to BLUE, items in the drum (of other steam sterilizing container) can be used.
If the TST control spot has NOT changed to BLUE, items in the drum (of other steam sterilizing container) MUST NOT BE USED, they must be re-sterilized, using a new TST control spot.

Packaging & Labelling:
Primary packaging: Unit of use.
One (1) plastic pack of 300 TST indicator spots.

Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Lot number prefixed by the word "LOT"
(of equivalent harmonised symbol) (if applicable).
Expiry date by year and month, prefixed by the word "EXP" (of equivalent harmonised symbol) (if applicable).
The words "for single use" (of equivalent harmonised symbol).
The words "destroy after use" (if space allows).
Number of units per primary packaging (if applicable).
Information for particular storage conditions
(temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
CE mark
Manufacturer's instruction for use. Alternatively, the instruction for use can be indicated on a separate insert.

Secondary packaging: Protected unit.
Fifty (50) packs in a box.
Labelling on the secondary packaging:
Labelling to be the same as primary packaging.
Extra information required:
Number of units per secondary packaging.
Over packaging: Packaging unit.
Symbols used according ISO 15223
CE mark


Pack SizeAvg. Price
Pack of 300$16.87
Pack of 1500$30.45
Pack of 1050$55.97