ISO 11140-3 class 2 chemical indicators for Bowie-Dick tests: What Canadian Clinics Should Verify Before Ordering
What is ISO 11140-3 used for?
ISO 11140-3 is the part of the ISO 11140 series that covers class 2 chemical indicators for the Bowie and Dick-type steam penetration test. It applies to pre-vacuum sterilizers, where the test exists to fail if the chamber retains air. The indicator is read once per test, on an otherwise empty chamber, at the start of a day the sterilizer is used.
Our own monitoring line: CliniEco Bowie-Dick Test Pack - ISO 11140-5 Type 2, 6-Pack, CliniEco Steam Chemical Integrator - Class 5, 100-Pack and CliniEco Autoclave Indicator Tape - 3-Roll Set, all listed in the sterilization monitoring collection.
Which part of ISO 11140 applies to a Bowie-Dick test pack?
This is where most purchasing mistakes start. Three parts of the same series cover class 2 indicators, and a pack should name the one it was made to.
| Part | What it covers | Where you meet it |
|---|---|---|
| ISO 11140-3 | Class 2 indicator systems for the Bowie and Dick-type steam penetration test | The classic test sheet read inside a standard test pack |
| ISO 11140-4 | Class 2 indicators used as an alternative to the Bowie and Dick-type test | Alternative air-removal devices |
| ISO 11140-5 | Class 2 indicators for Bowie and Dick-type air removal tests | The designation printed on many commercially supplied test packs |
If a quotation describes a pack only as "Bowie-Dick type" and never names the part, the specification is incomplete.
How do you read a class 2 indicator after a cycle?
Read the indicator against the reference printed on it, and record the result. A uniform colour change across the sheet means the steam penetrated the pack; a patch, a paler centre or an uneven edge means air was retained and the load must not be released. Because the result is only meaningful on an empty chamber, a failed test is a sterilizer fault to investigate rather than a reason to re-run the same load.
What should a Canadian clinic verify before ordering Bowie-Dick packs?
Check the standard named on the pack, the sterilizer type the pack is intended for, the lot number for the daily log, and the quantity against the days the sterilizer is used. A clinic running a pre-vacuum unit five days a week uses roughly one pack per day of use, plus a margin for re-tests after a repair. Gravity displacement sterilizers do not take this test at all, which is the most common source of unnecessary ordering.
Work in dentistry? See the consumables listed in our dental practice supplies and the monitoring log sheets in the compliance log centre.
Buying for a clinic, lab or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers. Reselling? become a distributor.
References
- ISO 11140-3:2007 - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (checked 14 October 2026)
- ISO 11140-5:2007 - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests (checked 14 October 2026)
- Public Health Ontario - Reprocessing of medical equipment in health care settings (checked 14 October 2026)
Not sure how this applies to your own setup? Ask a sterilization compliance specialist — you’ll get a written answer specific to your equipment and province, with the regulation or standard cited.
Related Reading
- Bowie-Dick Test Packs: What Canadian Clinics Should Check Before Buying
- Bowie-Dick Test Packs: ISO 11140-5 Type 2 and Daily Vacuum Checks
- ISO 11140-1 Indicator Classes: The Type Tests Behind Every Strip and Tape
Frequently Asked Questions
What is ISO 11140-3?
It is part of the ISO 11140 series on chemical indicators for sterilization. Part 3 specifies the class 2 indicator systems used in the Bowie and Dick-type steam penetration test, meaning the indicator sheet or pack read after an air-removal cycle on a pre-vacuum sterilizer.
Is ISO 11140-3 the same as ISO 11140-4 and ISO 11140-5?
No. Part 3 covers the class 2 indicator used in the classic Bowie and Dick-type steam penetration test, Part 4 covers class 2 indicators offered as an alternative to that test, and Part 5 covers class 2 indicators for Bowie and Dick-type air removal tests. All three are class 2 documents and none replaces the others.
Is a class 2 indicator the same thing as autoclave tape?
No. Autoclave tape is a class 1 process indicator: it shows that a package went through a cycle. A class 2 indicator is a test indicator built for one defined test, and on a pre-vacuum sterilizer that test is air removal.
What should a clinic check on a Bowie-Dick pack before ordering?
The standard named on the pack, the sterilizer type it is intended for, the lot number you will record on the daily log, and a pack count that matches the number of days the unit is used.
Last updated: October 2026. CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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