Which Standards Apply to HB105-S1 Dry Bath Incubator with Lid in the US vs Canada? Sizes and Sourcing

Which Standards Apply to HB105-S1 Dry Bath Incubator with Lid in the US vs Canada? Sizes and Sourcing

Which standards apply to an HB105-S1 in Canada and in the US?

A dry bath incubator does one job in a reprocessing room: it holds biological indicator vials at a steady temperature for a fixed readout window, so the result means something. The instrument is not licensed unit by unit in either country, which is why the standards that decide a purchase are the ones printed on the label, on the calibration sheet and on the distributor's paperwork. CliniEco lists the DLAB HB105-S1 dry bath incubator with lid — 20 wells, 115 V AC, and the notes below are what a Canadian buyer checks before signing against what a US buyer checks instead.

What does the 20-well block hold?

The single block holds one setpoint across all 20 wells, so a clinic that runs a steam cycle and a low-temperature cycle cannot hold the two regimes side by side: those vial sets go through as separate runs, or a second unit covers the overlap. Twenty wells covers the routine volume: a two-sterilizer practice testing every use day needs about ten wells a week, so a 20-well block carries a full week plus the control well and stays closed for the whole read period.

Which electrical standard has to appear on the label?

Canada works to CSA C22.2 No. 61010-1 and the United States works to UL 61010-1. Both are national adoptions of IEC 61010-1, so a unit built to the international text still needs the mark of the country it is sold in. The HB105-S1 carries a cTUVus mark (certificate CU 72205506 0001) that covers the Canadian and the US adoption at once, and the same certificate covers the HB105-S2, the wider variant we do not stock and have never shipped — the unit we supply and deliver is the HB105-S1 with 20 wells. A CE mark on its own does not answer either question. For electromagnetic compatibility the HB105-S1 carries FCC Part 15 Subpart B:2019 (AK 50495998 0001) for the United States and ICES-001:2006 (AK 50496013 0001) for Canada — one unit, two filings.

Does a dry bath incubator need a licence in Canada or the US?

In Canada the licence sits with the seller, not the device: a distributor must hold a Medical Device Establishment Licence, and CliniEco Medical operates under MDEL #35334. Nothing is registered per unit by the clinic. In the United States the buyer's file holds no equivalent distribution licence; what it holds is the listing mark and the temperature record. That difference in who keeps which paper is the practical answer to the question, and it is the one a purchasing officer should be able to repeat back before an order is raised.

How is block temperature verified after delivery?

With a calibrated probe, not with the display. Check three setpoints on arrival — room temperature plus five, the biological indicator incubation temperature, and one near the upper limit — then repeat a single point monthly at the incubation temperature. Write down the probe's calibration date beside each reading; a record that shows a number with no traceable instrument behind it is the first thing an auditor discards, and it costs nothing to avoid.

Which vials and consumables change with a 20-well block?

The bore fixes the vial, not the brand: an 11 mm well takes a self-contained vial with an 8 mm body and a 10 mm cap, which is the format of the CliniEco 1-hour rapid-readout biological indicator, 50-pack. A clinic still on 24-hour readout orders the 24-hour self-contained biological indicator, 50-pack and accepts the longer wait for the same wells.

Where do Canadian and US buyers place the order?

On one account, with the listing mark, the certificate number and the calibration sheet in the same request. Dental and laboratory buyers can start from the laboratory and diagnostic supplies page, which groups the monitoring lines that travel with an incubator.

Ordering 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

1. ISO 11138-1:2017 (checked 18 October 2026)
2. Infection Prevention and Control (checked 18 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

• Incubator Well Count: 6, 10 or 15 Wells — What a Canadian Clinic Should Buy
• Biological Indicator Incubation Time: 24 Hours vs 48 Hours Explained

Frequently Asked Questions

Which standards apply to an HB105-S1 dry bath incubator in Canada?

The instrument is built to IEC 61010-1 and carries a listing mark for both markets. In Canada the distributor holds a Medical Device Establishment Licence, the block temperature is verified against a traceable probe, and the biological indicator vials used in it are made to ISO 11138-1.

Does a dry bath incubator need to be licensed in the US?

No unit-by-unit licence is issued to the buyer. What a US facility keeps is the electrical listing mark on the label and the calibration record for the block, so the paperwork a buyer files is a temperature record rather than a registration number.

Why does the listing URL still say HB120-S?

Because the page previously covered the HB120-S without a lid. The unit now shipping is the HB105-S1 with a transparent lid and 20 wells, and the old address was kept so existing links and orders continue to land on the right page.

Can one incubator serve two sterilizers?

Yes, if the wells and the readout window line up. Two sterilizers tested every use day means ten vials a week, which fits comfortably in a 20-well block as long as the incubation temperature is one setting rather than two.

Last updated: October 2026. CliniEco Medical is a licensed medical device establishment (MDEL #35334).