ANSI/AAMI ST58 is the standard that sets out how a health care facility selects and uses liquid chemical sterilants and high-level disinfectants (LCSs/HLDs), together with the gaseous chemical sterilizers that are cleared for that setting. It is a United States standard, written around products cleared by the U.S. Food and Drug Administration, and it does not by itself create a duty in Canada. What follows is how the chemical sterilization and high-level disinfection obligations actually land for a Canadian clinic, care home or laboratory: which devices belong in which category, the three process parameters a compliant record has to carry, how long a working solution may be reused, what ventilation and protection the chemistry demands, and the evidence that turns a cycle into a failure.
Quick facts
- ANSI/AAMI ST58:2024 is titled Chemical sterilization and high-level disinfection in health care facilities.
- Its subject is the selection and use of liquid chemical sterilants and high-level disinfectants, and of gaseous chemical sterilizers cleared for marketing by the U.S. Food and Drug Administration for use in hospitals and other health care facilities.
- In Canada, the same work is governed by provincial reprocessing guidance and the CSA Z314 series, and a disinfectant used on medical equipment or devices has to carry a Drug Identification Number (DIN) from Health Canada.
- The record for a chemical process carries three parameters at once: concentration, temperature and contact time. A record that is missing one of them does not stand as a record of that process.
- High-level disinfection is the level applied to semicritical devices; critical devices require sterilization.
What AAMI ST58 covers, and what it does not
ANSI/AAMI ST58:2024 is a recommended practice for the chemical side of reprocessing. Its scope is the selection and use of liquid chemical sterilants and high-level disinfectants, and of gaseous chemical sterilizers, where those products have been cleared for marketing by the U.S. Food and Drug Administration for use in hospitals and other health care facilities. The standard also reaches the functional and physical design criteria for the equipment and areas in which that chemistry is handled.
The important boundary is jurisdictional. AAMI ST58 is a voluntary, United States-developed standard. In Canada the enforceable expectations around reprocessing come from a different set of instruments: the provincial reprocessing guidance for health care settings, the college standards of practice that apply to a regulated profession, and the CSA Z314 series of decontamination standards. AAMI ST58 is a useful engineering reference for how a chemical process should be selected, monitored and recorded, but a Canadian facility does not satisfy its own obligations simply by following it.
Table 1 — AAMI ST58 against the Canadian instruments
| Question | AAMI ST58:2024 | Where the Canadian requirement sits |
|---|---|---|
| What it governs | Selection and use of LCSs/HLDs and gaseous chemical sterilizers, plus design criteria for the area | Provincial reprocessing guidance and the CSA Z314 decontamination series |
| Who it binds | Health care facilities as users of the process | Facilities and regulated health professionals, through provincial guidance and college standards of practice |
| Product clearance named | U.S. Food and Drug Administration marketing clearance | Drug Identification Number (DIN) for a disinfectant used on equipment or devices [CSA Z314.8] |
| Process parameters of record | Concentration, temperature and contact time | Same three parameters, carried in the reprocessing record |
| Strength in Canada | Reference and engineering detail | Guidance and standard of practice that a facility is measured against |
Where chemical sterilization and high-level disinfection sit
Reprocessing levels are set by how the device is used, not by how it looks. A device that enters sterile tissue or the bloodstream is critical and has to be sterilized. A device that contacts mucous membranes or non-intact skin is semicritical and needs, at minimum, high-level disinfection. A device that contacts only intact skin is noncritical and needs low-level disinfection.
Chemical sterilization exists because some critical and semicritical devices cannot tolerate steam. The general standard for a sterilizing agent, ISO 14937:2009, sets out the requirements for characterising the agent and for developing, validating and routinely controlling the process; ISO 14160:2020 does the same for liquid chemical sterilizing agents applied to single-use devices that contain materials of animal origin. The chemistry used on a semicritical device is the high-level disinfectant; the same chemistry used with a much longer immersion becomes the liquid chemical sterilant for a critical device.
The three parameters that make a chemical record stand
This is the part of chemical reprocessing that clinics get wrong most often, and it is the part that a review will test. A chemical process is defined by three variables acting together:
- Concentration — the strength of the active ingredient actually in the in-use solution.
- Temperature — the temperature of the solution or the chamber during contact.
- Contact time — how long the device was immersed or exposed at that strength and temperature.
The published provincial guidance states the relationship directly. Its endoscope reprocessing procedure instructs the operator to follow the manufacturer's directions on ambient temperature and exposure time, and gives 2% glutaraldehyde at 20°C for 20 minutes as the worked example. Change any one figure and the process is a different process. A logged temperature with no contact time is not a process record; a logged contact time with no concentration test is a claim the facility cannot support; a strip test with no solution temperature leaves the middle of the equation blank.
Table 2 — The three parameters, how each is verified and what gets recorded
| Parameter | What it controls | How it is verified | Record field |
|---|---|---|---|
| Concentration | Whether the in-use solution is still at effective strength | Chemical test strip used before processing, tested daily if the solution is used daily, and checked with positive and negative controls when a new bottle or package is opened | Result of each test of the disinfectant, with the date |
| Temperature | Whether the solution or chamber is within the range the label requires | Manufacturer's stated range, checked against the instrument reading | The temperature in force during the process |
| Contact time | Whether exposure matched the label for that strength and temperature | Immersion time measured against the label, for the concentration and temperature in use | Concentration and contact time of the disinfectant used in each process |
| Device identity | What was actually reprocessed | Each load or item identified before processing | Identification of the equipment or device to be disinfected |
| Result and operator | Who confirmed the outcome | Inspection result, and for endoscopes each leak test | Result of each inspection and the name of the person completing the reprocessing |
The concentration and contact time of the disinfectant used in each process, the result of each test of the disinfectant, and the identity of the device are all named as fields the processing record has to include. The provincial instrument that carries the strongest wording puts it in a use requirement: where a chemical product is used, the concentration of the active ingredient has to be verified and a logbook of daily concentration test results maintained.
Solution life, reuse and the concentration test
A high-level disinfectant is not a permanent supply. The same provincial guidance describes the mechanism plainly: a working solution loses strength through use and dilution, which is exactly why an effective-concentration test exists. Three rules follow from that.
- Test at the frequency of use. The strip test is run before processing, and daily if the solution is used daily, at a minimum following the manufacturer's instruction.
- Control the strip itself. Each time a new package or bottle of strips is opened, it has to be checked with a positive control (full-strength solution) and a negative control (tap water) so that a passing strip means something.
- A test strip is not a shelf-life extension. Test strips must not be treated as a way of using a solution past its expiry. Reuse life is bounded by the label: for a glutaraldehyde-based sterilant the published guidance notes a working life of up to 14 days once activated, after which the solution is discarded regardless of what a strip shows.
Ventilation, containment and protection
The aldehydes and oxidisers used for high-level disinfection are workplace hazards as well as process chemicals. The reprocessing area is required to have a ventilation system that removes the vapours the chemicals emit, and the vapour concentration of the disinfectant used is not permitted to exceed the allowable limit — the published guidance gives a ceiling of 0.05 ppm as the example for glutaraldehyde. In-use solutions are kept in closed, covered and labelled containers.
Because they are hazardous chemicals, the products arrive with a safety data sheet and a hazard classification under WHMIS and the globally harmonised system, which is where the required glove, eye and respiratory protection is stated. Aldehydes such as formaldehyde and glutaraldehyde are irritants and sensitisers, which is why the aldehyde profile is a standard reference for the strength of the protection needed. The controls that reduce exposure are the standard hierarchy: enclose or contain the process, ventilate the area, and use the personal protective equipment the safety data sheet specifies.
What counts as a failure
A chemical reprocessing failure is not limited to a device that is visibly dirty. Any of the following breaks the process, and the response is the same: the load does not get released and the items are reprocessed.
Table 3 — Failure signals and the required response
| Failure signal | What it means | Required response |
|---|---|---|
| Strips show the solution is below effective concentration | The in-use solution is no longer at the strength the label requires | Replace the solution before the next process; do not process into it |
| Solution past its reuse life or expiry | Reuse life is bounded by the label, not by a passing strip | Discard the solution and start a fresh one |
| Temperature or contact time off the label | The process delivered was not the validated process | Reprocess the device under the correct parameters |
| A required record field is missing | The process cannot be shown to have happened as specified | Reconstruct the record before release, or reprocess |
| No concentration log for a day the solution was used | The verification requirement was not met | Treat the day's processes as unverified and reprocess |
Where the Canadian requirements actually sit
For a Canadian facility, two instruments do most of the work. Provincial reprocessing guidance for health care settings sets out the disinfectant categories, the monitoring and auditing requirements for high-level disinfection, the DIN requirement, and the ventilation and record fields described above. College standards of practice add the profession-specific layer; the dental standard of practice in Ontario, for example, requires a biological indicator in a process challenge device for each type of cycle used on each day the sterilizer is used, requires routine loads not to be released until that result is available, and requires the sterilizer log book to be kept for at least 10 years from the last entry.
That Ontario cadence is a daily one, and it is worth stating the contrast clearly, because the confusion is common: a weekly monitoring cadence is the published national baseline in United States practice and in the U.S. standards used in that market. It is not the Ontario requirement, and it is not the requirement of the CSA Z314 series or of Health Canada, so a Canadian facility that adopts it as its own policy has adopted an interval that does not match the standard of practice it is measured against.
For facilities rebuilding the records behind this work, the sterilization compliance hub collects the standards and monitoring material in one place, the sterility assurance level explainer sets out what the assurance numbers mean, and the sterilization monitoring collection groups the indicators and readers that support the monitoring side. Teams documenting a chemical programme often start from the Class 5 chemical integrator and the Class 4 dual-indicator pouches that carry the pack-level record, can begin a monitoring programme with the biological indicator 5-pack trial, and can move to case-level ordering through a wholesale account. Reselling? become a distributor.
CliniEco Medical supplies biological indicators, incubators and sterilization monitoring consumables for Canadian care settings (MDEL #35334).
Keep the three parameters on one page. A chemical process record only stands if concentration, temperature and contact time sit beside the device identity — which is why the record is a form, not a memory exercise. The printable sterilization log sheet prints a blank sheet built on the four record groups and 20 fields that mirror the record-keeping sections of the RCDSO IPAC Self Audit Review Form (v2), and the load log and label generators turn a month of cycles into a dated page you can print or export without an account.
Have a question about your own facility? Send it in and you will get a written answer specific to your setup, with the regulation or standard it is based on cited. Ask your compliance question.
This article describes standards and guidance published by third parties and is not a substitute for the standard of practice that governs your setting, the instrument or disinfectant manufacturer's validated instructions, or the requirements of your provincial regulator.
Where to Buy Biological Indicators in Canada
CliniEco Medical supplies these from Ontario with published CAD pricing (MDEL #35334) — no quote required, and each pack ships with the lot number printed on it so your monitoring record stays traceable.
| Format | Pack size | Price (CAD) | |
|---|---|---|---|
| 24-hour self-contained | 25-pack | $84.99 | Order |
| 24-hour self-contained | 100-pack | $299.00 | Order |
| 3-hour rapid fluorescence | 50-pack | $274.99 | Order |
Round Out Your Sterilization Setup
A biological indicator is one link in the chain — these are the pieces it works with:
- Autoclave indicator tape — 3-roll set — the external chemical indicator on every pack
- Sterilization roll — 50 m pre-cut sheets for larger instruments
- Constant-heat pouch sealer — 200 °C, 12 mm seal — for consistent pouch closures
Which format does your sterilizer actually need?
Match the readout time to how fast you need the result: a 24-hour self-contained indicator works in any gravity or pre-vacuum cycle with a standard incubator, while a 3-hour fluorescence tube needs the matching reader. Running one cycle type per day, the 25-pack covers a month; busier clinics move to the 100-pack and cut the per-test cost.
How much do spore tests cost in Canada?
Published pricing runs $3.40 per test on the 25-pack down to $2.99 on the 100-pack — no distributor quote, no account needed.
Not sure which format your sterilizer needs? Generate a free sterilization log sheet first — it maps your cycles and tells you the pack size that fits. Questions about your setup? Ask a Compliance Specialist.
Related reading
- Spaulding Classification: How Critical, Semicritical and Noncritical Drive Reprocessing
- What the Spaulding Classification Means for High-Level Disinfection
- ISO 14160:2020 — Liquid Chemical Sterilants for Animal-Tissue Devices
- Endoscopy Reprocessing Supplies: High-Level Disinfection Basics
- Medical Device Reprocessing and Sterilization in Canadian Health Care Facilities
Frequently Asked Questions
Does AAMI ST58 apply in Canada?
AAMI ST58 is a United States-developed voluntary standard, written around products cleared by the U.S. Food and Drug Administration. It is a useful engineering reference, but it does not create a duty in Canada. For a Canadian facility the expectations come from provincial reprocessing guidance, the applicable college standard of practice and the CSA Z314 series.
What is the difference between chemical sterilization and high-level disinfection?
The difference is the level of microbial kill and the devices each serves. High-level disinfection eliminates all vegetative organisms, fungi, mycobacteria and non-enveloped viruses but not high numbers of bacterial spores, and is the level used for semicritical devices. Chemical sterilization kills all microbial life including spores and is used for critical devices that cannot tolerate steam, reached by a much longer immersion in the same chemistry.
Which three parameters must a chemical process record carry?
Concentration, temperature and contact time. The in-use solution has to be at effective strength, the process has to run at the temperature the label states, and the exposure has to match the label for that strength and temperature. A record missing any one of the three does not document a valid process.
How often must a high-level disinfectant solution be concentration-tested?
The in-use solution has to be tested with a chemical test strip before processing, tested daily if the solution is used daily, and in any case at the minimum frequency the manufacturer sets. Each new package of strips must itself be checked with positive and negative controls before it is relied on.
Can a test strip extend how long a disinfectant solution is used?
No. A passing strip is not a shelf-life extension. Reuse life is bounded by the product label — for a glutaraldehyde-based sterilant the published guidance notes up to 14 days once activated — and the solution is discarded at the end of that period regardless of the strip result.
What ventilation does a high-level disinfection area need?
The reprocessing area needs a ventilation system that removes the vapours the chemicals emit, sized so that the vapour concentration does not exceed the allowable limit; the published guidance gives 0.05 ppm as the example for glutaraldehyde. In-use solutions are kept in closed, covered and labelled containers, and the protection the safety data sheet states is worn.
Is weekly sterilizer monitoring acceptable in Ontario?
No. The Ontario dental standard of practice requires a biological indicator in a process challenge device for each type of cycle used on each day the sterilizer is used, and routine loads are not released until that result is available. A weekly cadence is the published national baseline in United States practice and is not the Ontario requirement.
Sources
- ANSI/AAMI ST58:2024 — Chemical sterilization and high-level disinfection in health care facilities (AAMI)
- ISO 14937:2009 — characterization of a sterilizing agent and validation of a sterilization process
- ISO 14160:2020 — liquid chemical sterilizing agents for single-use devices using animal tissues
- ISO 15883-1:2024 — washer-disinfectors, general requirements (official preview, PDF)
- Public Health Ontario — provincial guidance on cleaning, disinfection and sterilization in health care settings (PDF)
- Public Health Ontario — reprocessing of medical equipment and devices
- Royal College of Dental Surgeons of Ontario — infection prevention and control standard of practice (PDF)
- Royal College of Dental Surgeons of Ontario — infection prevention and control resources
- Health Canada — guidance on information to be provided for the reprocessing and sterilization of reusable medical devices (PDF)
- Health Canada — list of hard-surface disinfectants authorized for sale in Canada
- U.S. Food and Drug Administration — reprocessing medical devices in health care settings: validation methods and labeling
- U.S. Centers for Disease Control and Prevention — guideline for disinfection and sterilization in healthcare facilities (PDF)
- CCOHS — chemicals topic, occupational health and safety information
- CCOHS — WHMIS and the globally harmonised system of hazard classification
- CCOHS — formaldehyde chemical profile, aldehyde hazard reference
- Occupational Safety and Health Administration — glutaraldehyde exposure and sampling data
- U.S. National Institute for Occupational Safety and Health — glutaraldehyde in health care
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