TEST, BOWIE-DICK, ready to use pack, s.u.
STD
ESTETBOD1--
Valid Article
Account code:
60210
HS Code:
382290
Last Updated on:
07/11/2024, 17:58:06
Former
Code(s):
-X
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
Z12011385 - Cleaning, disinfection and sterilisation instruments - consumables
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
OC subscriptions: included in supply or field order tools (e.g. UniField)
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SC subscriptions: included in supply or field tools
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OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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TEST, BOWIE-DICK
Test intended for steam autoclaves equipped with a vacuum pump only!
NOT to be used with the TBM 90l or the All American autoclaves.
Definition
Chemical indicator type 2, allowing to check the steam penetration into the load and the absence of residual air or non compressible gas in the chamber of saturated steam sterilizers.
It is presented as a test pack representing a porous load -pack of cotton linen- in the centre of which a coloured chemical indicator is placed which changes of colour when in contact with steam at 134°C, 2 bars, for 3.5 minutes.
It is used to control the good working order of a steam autoclave.
Specifications
- Indicator: sheet with geometrical figure printed with thermosensitive ink, placed between two porous cardboard sheets
- Wrapping: perforated aluminium complex film
Quality standards
- ISO 11140-1, 2014, edition 3, (confirmed 2021) Sterilization of health care products – chemical indicators –Part 1: General requirements
- ISO 11140-3, 2007, edition 2, (confirmed 2021) Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
- ISO 11140-5, 2007, edition 2, (confirmed 2021) Sterilization of health care products -- Chemical indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
Technical specifications
- Ready to use test
- Chemical indicator of type 2
- Dimensions: 12.5 x 12.5 x 0.7 cm
- For single use
- Unit presentation
Packaging & Labelling
Box of 30 tests
Instructions for use
- Test intended for steam autoclaves equipped with a vacuum pump only.
- Perform the test every morning in an empty autoclave before starting the sterilization cycles.
- Never unpack the test before use. Use the test as it is without wrapping it in crepe paper.
- Place the test horizontally in the geographic middle of the autoclave.
- Run the specific cycle for Bowie-Dick: 134ºC, 2 bars during 3 min 30 sec. The duration of the temperature–pressure plateau must be strictly followed.
- Let the test cool down, unpack and read the result. The colour of the indicator must turn from purple (dark red) into green in an uniform way (reference charts are available on request)
- Write the date and the number of the cycle on the indicator sheet and archive it according to the established protocol in the field
- In case of incorrect change of colour of the test (not uniform, partial discolouring...), check the good working order of the vacuum pump on the pressure registration graph:
- If the graph is not OK, inform the logistician.
- If the graph is OK, run another Bowie-Dick cycle with a new test. If the problem test also fails, ask the logistician to check the tightness of the autoclave (closing of the door, door gasket…)
Storage
- Temperature before and after use: 0 - 30°C, Protect from sunlight - Protect from humidity
- Relative humidity between 30 – 60 %
MSF requirements
Allows controlling the good working order of the steam autoclaves with vacuum pump.
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