Indicator,TST control spot/PAC-300

GENERAL DESCRIPTION
Indicator TST control spot for steam sterilization process, pack of 300.

INTENDED USE
A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or 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)
Weight: 45 gr.
Volume: 0.1 dm³.

RELATED PRODUCTS
S0845176, Masking tape, type 1 steam indicator
S0845177, Papersheet,crepe,for ster. pack/PAC-250

COMPONENT OF A KIT
S9901030, IEHK2017,kit,suppl.3-renewable
S9908200, Sterilization, kit C

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDR 2017/745 as Class I device.

SAFETY AND PRODUCT STANDARDS
- ISO 11140-1:2014, Class 6: Sterilization of health care products — Chemical indicators — Part 1: General requirements.

NOMENCLATURE
GMDN Code: 35362

INSTRUCTIONS FOR USE
The use of TST control spot gives an immediate indication to the person in charge on successful sterilisation cycle or not.
TST control spot must be used systematically for each steam sterilization cycle.
TST control spot must be attached to the lid of drum (or 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 or fail, remedial action taken to remedy failed cycles.
If the TST control spot has changed from YELLOW to BLUE, items in the drum (or other steam sterilizing container) can be used.
If the TST control spot has NOT changed to BLUE, items in the drum (or other steam sterilizing container) MUST NOT BE USED, they must be re-sterilized, using a new TST control spot.