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Equipment in a medical laboratory covers everything from analyzers and centrifuges to incubators, cabinets and cold storage. This guide maps the main equipment classes and then covers what the US CLIA rules (42 CFR Part 493) require a laboratory to do once equipment is in use. It is written for lab managers, technicians, students and buyers who need to know what to ask for and what must be documented.
This page describes products and general use; it is not medical advice.
What counts as equipment in a medical laboratory
Equipment (also searched as “equipments” or “machines” in a medical laboratory) means the durable instruments and devices a lab uses to receive, process, test and store specimens. Consumables and reagents (tubes, tips, kits, solutions) are different: they are used up, carry expiry dates and are governed by their own labeling and storage rules, covered below.
Main equipment classes
The classes below follow the categories used in the McKesson Medical-Surgical overview “Laboratory equipment and its impact on healthcare” (a vendor overview of equipment categories). The roles are general descriptions, not selection advice.
| Class | General role | More on CASRAI |
|---|---|---|
| Analytical instruments (analyzers, hematology, PCR) | Measure or detect analytes in specimens | Covered by the manufacturer’s instructions for each analyzer |
| Sample preparation (centrifuges) | Separate specimen components before testing | How to choose a centrifuge |
| Sterilisation and cleaning (autoclaves) | Decontaminate instruments and materials | Autoclave buying guide |
| Containment (biosafety cabinets) | Protect staff and specimens during handling | Biosafety cabinet |
| Microscopy | Examine specimens visually | Specimen examination by eye |
| Incubators and cold storage (ultra-low freezers) | Hold cultures, reagents and specimens at set conditions | Biomedical equipment maintenance |
For office-level supplies rather than laboratory instruments, see medical supplies for a doctor’s office.
Machines versus consumables: why the rules differ
Under 42 CFR 493.1252, reagents, solutions, controls and supplies must be labeled with identity, storage requirements, preparation and expiration dates. Materials must not be used when they have exceeded their expiration date, have deteriorated or are of substandard quality, and components of reagent kits with different lot numbers must not be interchanged unless the manufacturer specifies otherwise (eCFR, checked 2026-11-01).
What CLIA requires once equipment is in use
Follow the manufacturer’s instructions
42 CFR 493.1252(a) requires testing to follow the manufacturer’s instructions, with results within the laboratory’s performance specifications.
Environment and storage conditions
The laboratory must define criteria for conditions essential to proper storage of reagents and specimens, accurate and reliable test system operation and test result reporting, consistent with the manufacturer’s instructions where provided. Those conditions must be monitored and documented. The rule names water quality, temperature, humidity, and protection of equipment from electrical current fluctuations and interruptions (42 CFR 493.1252(b)).
Maintenance and function checks
For unmodified manufacturer equipment, the laboratory performs and documents maintenance and function checks as defined by the manufacturer, at the manufacturer’s frequency or more often, and function checks must be within the manufacturer’s established limits before patient testing (42 CFR 493.1254(a)). For in-house, modified or unsupported equipment, the laboratory must define and document its own maintenance and function-check protocol, with checks within its own established limits before patient testing (493.1254(b)).
| Equipment status | Who defines maintenance and function checks | Rule |
|---|---|---|
| Unmodified manufacturer equipment | The manufacturer (frequency: theirs or more often) | 42 CFR 493.1254(a) |
| In-house, modified or unsupported equipment | The laboratory, documented | 42 CFR 493.1254(b) |
Calibration requirements sit in a separate section of Part 493 and are not covered on this page.
Working with medical laboratory suppliers: documents to request
The rules above imply what a laboratory must be able to document. Editorial interpretation: when talking to a supplier or distributor, ask for the items the lab will later have to show.
- The manufacturer’s instructions for use, including the maintenance and function-check schedule and the limits those checks must meet.
- The storage and environmental conditions the equipment and its reagents require (temperature, humidity, water quality, power).
- Labeling, lot and expiration information for reagents and supplies.
- Whether the equipment is unmodified manufacturer equipment, since that decides who defines the maintenance protocol.
See also medical equipment distributor.
Common mistakes
- Using reagents past expiration or mixing kit lots (493.1252(d), (e)).
- Not monitoring or recording storage temperature, humidity, water quality or power conditions (493.1252(b)).
- Running patient testing before the function checks are within limits (493.1254).
- Treating modified or in-house equipment as if the manufacturer’s schedule covered it.
FAQ
What equipment is used in a medical laboratory?
Common classes are analytical instruments, centrifuges, autoclaves, biosafety cabinets, microscopes, incubators and cold storage, as in the table above.
What are machines in a medical laboratory?
“Machines” is a common search term for laboratory instruments such as analyzers, centrifuges and autoclaves; the classes are listed in the table above.
Who decides how often equipment is maintained?
For unmodified manufacturer equipment, the manufacturer’s defined frequency or more often; for in-house or modified equipment, the laboratory defines its own documented protocol (42 CFR 493.1254).
What should I ask a medical laboratory supplier for?
Instructions for use, maintenance and function-check limits, storage conditions and labeling or expiry information, as listed above.
Sources
- eCFR, 42 CFR 493.1252, https://www.ecfr.gov/current/title-42/part-493/section-493.1252 (checked 2026-11-01).
- eCFR, 42 CFR 493.1254, https://www.ecfr.gov/current/title-42/part-493/section-493.1254 (checked 2026-11-01).
- McKesson Medical-Surgical, “Laboratory equipment and its impact on healthcare” (vendor overview of equipment categories), https://mms.mckesson.com/content/insights/laboratory-equipment-and-its-impact-on-healthcare/ (checked 2026-11-01).
