Tests & Indicators
Tests & Indicators: Helix Test, Indicator, Spore Test
Which test for which instruments — so no gap remains in the audit and you buy no more than you need.
Germany Austria Switzerland
Short answer
The rule of thumb: indicator per batch, Helix test on each working day for hollow instruments, vacuum test daily before operation and the spore test periodically. Exactly which one depends on your instrument class.
Which test for what?
Which test for which instruments?
Which test device you need depends on the risk class of your instruments. This table gives you quick guidance — so no gap remains in the audit while at the same time you buy no more than you need.
| Instruments | Recommended test device | Frequency |
|---|---|---|
| Semi-critical / simple geometry | Chemical indicator (e.g. Class 5) per batch | every load |
| Critical A (solid, critical) | Class 5 indicator in the batch | every load |
| Critical B / hollow instruments, narrow lumens | Helix test (hollow-body test device) | each working day |
| Functional test of vacuum/steam penetration | Vacuum test & Bowie-Dick/Helix check | each working day before operation |
| Periodic efficacy proof | Bioindicator / spore test | periodically & per standard |
The daily test routine — in brief
- Before the first sterile goods: run the vacuum or steam-penetration test.
- Document each batch with a process indicator and assign it to the batch.
- Regularly safeguard hollow-body instruments with a Helix test device.
- Record results in an audit-proof way — going digital with SteriTrace saves the paper filing.
Important: The test does not replace the validation. It proves the daily function; the validation demonstrates the fundamental suitability of your process.
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The most common concerns of our customers — and how we solve them.
„Which test exactly — I don't want a gap?“
The table assigns the right test device to every instrument type — with a matching starter set.
„Am I running the daily routine correctly?“
Our routine cheat sheet and the step-by-step help make the daily test watertight.
No test gap in the audit.
Helix test, indicators, spore test — the right test device for every instrument class, available immediately.
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Frequently Asked Questions
Tests & Indicators – key questions answered clearly.
Which sterilisation test is required for which instruments?
This depends on the risk class of the instruments: For unwrapped, simple instruments (semi-critical/critical A) a chemical indicator (e.g. Class 5) per batch is sufficient; for hollow bodies and narrow lumens (critical B) a Helix test is additionally required. Our table and the configurator assign the right test device to each instrument type.
Is a Helix test mandatory and when is it needed?
The Helix test is required for critical-B instruments (hollow bodies) or wrapped/semi-critical-B instruments and proves steam penetration. It does not necessarily have to be done on every cycle, but many people routinely place it in every batch. For the daily routine check on Class B autoclaves it is approved.
Do I need a spore test and can I have it carried out?
A spore test is not mandatory for autoclaves in Germany; Class 5 or Helix tests are sufficient. However, spore tests are possible and are particularly useful for critical-B instruments. Whether a periodic spore test is necessary is best clarified with our validation partner.
How and how often is the vacuum test carried out and how long does it take?
You should carry out the vacuum test yourself, once a week in the morning with a cold chamber (it will not start with a warm chamber). Switch on the device and navigate in the menu to the vacuum test. It is standardised in EN 13060 and takes approx. 15-20 minutes.
Which indicators or strips must be retained?
Indicator, batch and steriliser indicator strips (including Helix test strips) no longer have to be retained long-term (batch indicators since 2011, sterile strips since 2021). The washer-disinfector indicators also do not have to be retained. The batch release itself, however, must still be documented.
Which two indicator checks are the most important in practice?
In Germany essentially two checks are relevant: the Helix test steam indicator (for critical B or wrapped instruments) and the Class 5 steam indicator (for critical A or unwrapped instruments). The Bowie & Dick test is only needed for textiles. In addition there is indicator adhesive tape and spore tests.
Which standard is the Helix test certified to?
The Helix test device is certified to ISO 11140-1:2014 (Type 2) or EN 867-5:2001. Instructions for use for the Helix test and the other tests are available on request.
How often can a Helix test be used and how long must sterilisation take for it?
A Helix test usually contains 100, 250 or up to 400 test strips, and can be used that many times (observe the expiry date). The Helix test is standardised in EN 13060 and is autoclaved for 3.5 minutes at 134 °C; on Steri24 autoclaves the Helix programme is preset accordingly.
Which Helix test may I use for my device?
You can use any Helix test as long as it meets the standard - it does not have to be from the same manufacturer. It is advisable to stay with the test that was used at the last validation (documented in the validation report).
Why does the Helix or steam indicator strip not show a sterile result (brown instead of black)?
A frequent cause is the wrong programme: For the Helix test (hollow bodies) the hollow-body or Class B programme (several pre-vacuum steps, 134 °C, holding time, drying) must be selected, not the solid programme for unwrapped instruments. If the strip stays brown with the correct programme, the autoclave is probably defective - please contact service.
Do I additionally need a Class 5 indicator if I run a Helix test with every batch?
No. If a Helix test is in the chamber with every batch, you do not need an additional Class 5 indicator.
Is the test programme on the device enough or do I additionally need test strips?
You need test strips for the daily routine check: The test strip goes into the first cycle of the day (one pack lasts for approx. 100 steri days). The integrated test programme is only needed by the validator or service.
Do the Helix test and vacuum test replace the validation?
No. The Helix and vacuum tests only show partial aspects: The Helix test checks steam penetration into hollow bodies, the vacuum test the tightness of the system. The initial validation, by contrast, assesses the entire reprocessing process and is mandatory for users in human medicine.
Is a Class 5 indicator sufficient for unwrapped instruments?
For unwrapped instruments (semi-critical A or critical A) a Class 5 steam indicator placed in with the load is sufficient according to RKI/KRINKO. A Helix test is not required here.
Must the Helix test or end-of-day record additionally be documented if a personnel-code safeguard is used?
The Helix test documentation is required according to RKI and the Federal Dental Association independently of a personnel-code safeguard on the autoclave. An additional handwritten end-of-day protocol with a negative list, however, is no longer required since 2021 when using software with password release.
What does an error during the vacuum test (Fail 01/02) mean and what should be done?
An error during the vacuum test (Fail 01/02) usually indicates that air is flowing into the chamber and that the contact pressure of the door seal must be increased or the seal replaced. A short guide can be found on the inside of the door; if that does not help, please contact our service.
How long is a Helix test system usable?
Helix test systems have a printed expiry date that is usually several years in the future. Use the test strips only within this period; the exact date is on the packaging.
What does a used Helix test strip look like after a successful run?
With the vacuum test the device shows the result OK; with other programmes the time and temperature appear at the end. How a passed Helix test strip must look depends on the indicator and is stated on the packaging - usually a complete colour change.
What is the difference between batch control and periodic testing?
Batch control (e.g. a process indicator per batch) documents the process for each individual load. Periodic tests such as the steam-penetration test are run at set intervals and detect deviations that a single batch control does not show. The two complement each other.
What is the difference between the Helix test and the Bowie-Dick test?
The Helix test checks steam penetration in hollow bodies and narrow lumens and is the practical test for critical-B instruments. The Bowie-Dick test is a steam-penetration test for porous goods or textiles. For most practices without a textile load, the Helix test is the relevant test.
How often should the Helix test be carried out?
As a working-day routine check it is recommended to run the Helix test at least once per treatment day if hollow bodies or wrapped critical-B instruments are sterilised. For simplicity, many practices place it in every batch.
What is a process indicator and when do I need it?
A process indicator (chemical indicator, e.g. Class 5) is placed in every batch and shows by a colour change whether the sterilisation parameters were reached. It serves as a batch-related routine check and belongs in every load of unwrapped instruments.
What is a test device (PCD) in the Helix test?
The test device (Process Challenge Device) simulates a hollow-body instrument with a long, narrow lumen. The indicator strip is placed inside it; if the steam reaches the end of the strip completely, steam penetration is also proven for your hollow-body instruments.
Which test organism is used for sterilisation?
Geobacillus stearothermophilus serves as the test organism for the success of thermal sterilisation processes. This heat-resistant spore former is the basis of bioindicators or spore tests.
What is a bioindicator and how does it differ from a chemical indicator?
A bioindicator (spore test) contains living, heat-resistant spores and, after incubation, directly proves the killing of microorganisms. A chemical indicator, by contrast, only shows via a colour change whether certain physical parameters were reached. The bioindicator is the most direct proof of efficacy.
Is recurring monitoring of the cleaning performance of the washer-disinfector mandatory?
This depends on the federal state: In some federal states recurring checks of the cleaning performance of a washer-disinfector are required. A suitable standard operating procedure for critical instruments can be requested from your responsible authority.
Do you offer a prion test?
Yes, we offer steam indicators with which the killing of prions can be inferred. In addition, all our autoclaves have a prion programme. Details and ordering gladly via our consultation.
When is a prion indicator or programme relevant?
The prion programme sterilises with an extended holding time and is required above all in Switzerland and France. With a suitable steam indicator the prion cycle can additionally be monitored. Our consultation will clarify which requirements apply to you.
Where do I find templates and forms for documentation and batch release?
We provide free templates for documentation and batch release, including a handwritten batch-release form as well as a detailed knowledge document in our wiki. Alternatively, digital documentation via SteriTrace is possible.
How is the batch release documented and what must it contain?
The batch release must be documented according to RKI - by hand (e.g. with a batch-release template and a sterilisation pen) or digitally with SteriTrace. Labels or a barcode are not mandatory; handwritten marking is also permitted. For critical instruments there is a batch-tracking and labelling obligation.
Does digital documentation save the test and paper filing?
Yes. With SteriTrace, batches, indicator results and releases are recorded digitally in an audit-proof way, so that paper filing is no longer needed. The test results themselves no longer have to be retained long-term anyway; what is documented is the batch release.
Is it enough if I only run the vacuum-test programme on the device?
The vacuum-test programme only checks the tightness and air removal of the system. For the complete routine proof you additionally need the batch-related indicator check (Class 5 or Helix test). Only the two together cover functional testing and batch control.
Do I have to document the vacuum test?
The result of the vacuum test should be recorded as part of the routine tests so that in the audit the daily or weekly functional check is documented. With SteriTrace the result can be recorded digitally directly.
What does indicator adhesive tape check?
Indicator adhesive tape only shows via a colour change that a sterilisation process has been run - it distinguishes sterilised packages from untreated ones. It is a process indicator and does not replace the Class 5 or Helix test as a batch control.
What do the indicator classes mean, e.g. Class 5?
Indicators are classified into classes according to ISO 11140: process indicators only show that a process took place, while an integrating Class 5 indicator evaluates several critical parameters (time, temperature, steam) together. For batch control of unwrapped instruments, Class 5 is typically used.
Which tests do I need to start with a new autoclave?
In principle the autoclave is ready to use straight away. For cycle control we recommend, depending on the risk class, Class 5 steam indicators or Helix test strips as well as a sterilisation pen for labelling. Our configurator puts together the right starter set.
Do I get the matching tests in a set with the autoclave?
Yes. Our sets bundle the autoclave with matching accessories at a reduced price and usually contain the essentials for instrument reprocessing, depending on the set also a Helix test. Via the configurator you put together the autoclave, tests and further accessories individually.
Can I configure the autoclave and tests individually?
Yes, you can put together your basket individually - for example an autoclave plus sealing device, Helix test and sterilisation rolls - or we can create an individual package offer. The easiest way is via the configurator.
Which tests are most often a problem in the audit?
The most common stumbling block is a gap between the instrument type and the chosen test device - for example no Helix test for hollow-body instruments or an incompletely documented batch release. Our table assigns the right test device to each instrument type so that no gap remains in the audit.
What does a correct daily test routine look like?
Before the first sterile goods, run the vacuum or steam-penetration test, document each batch with a process indicator and assign it to the batch, regularly safeguard hollow-body instruments with the Helix test device and record the results in an audit-proof way - digitally with SteriTrace.
What exactly does the vacuum test check?
The vacuum test proves the tightness of the chamber system and ensures that no air enters that would disturb steam penetration. It is a functional test and does not check the load itself.
Why does the vacuum test not start?
The vacuum test only runs with a cold chamber. If the device is still warm from the last run, it will not start. Therefore run it in the morning before the first cycle when the device has cooled down.
Do beauty, tattoo and podiatry studios need the same tests as a medical practice?
This depends on the instruments used, not on the sector. If hollow-body instruments are sterilised wrapped, the Helix test applies here too; for simple, unwrapped instruments a Class 5 indicator per batch is sufficient. Our consultation will clarify this for your use case.
Do veterinary practices also have to carry out sterilisation tests?
In the veterinary field, too, functional and batch checks are useful and partly required in order to document reprocessing traceably. Which tests are specifically necessary depends on the instruments and the regional requirements - we will be happy to advise you on this.
How does the test routine differ between Class B and simpler autoclaves?
Class B autoclaves with fractionated pre-vacuum also sterilise wrapped hollow bodies and are monitored with the vacuum and Helix test. For critical-B instruments, Class B is a prerequisite; you will find the right device plus tests via the configurator.
Can the test results be transferred to my practice software?
Yes, the Premium autoclaves in particular can be connected via LAN/WLAN or a serial interface to common practice and documentation software, so that the batch and test documentation is also transferred digitally. Our technician handles the setup.
Can I carry out the batch release directly on the autoclave?
With the Premium autoclave you can carry out and document the batch release according to RKI directly on the touchscreen, including the Helix or indicator result. With the Pro, documentation is done via an integrated printer or USB.
What is the difference between a test and validation?
The test proves the daily or batch-related function (e.g. steam penetration, tightness). Validation, by contrast, demonstrates the fundamental suitability of your reprocessing process at the place of use and is mandatory for human medicine. The test does not replace the validation.
How does Steri24 help me select the right tests?
Our table assigns the right test device to each instrument type, the routine cheat sheet makes the daily test watertight, and the configurator puts together the device plus tests. If you are unsure, we advise you personally and via our on-site service in DACH.
Do I get instructions for use for the tests?
Yes, instructions for use for the Helix test and the other sterilisation tests are available on request. This ensures that you select the right programme and evaluate the results correctly.