THE AME STANDARD —
EIGHT DOMAINS. ONE FRAMEWORK. ANY DEVICE.
AME defines what it means for a medical device to be truly fit for purpose in a low- or middle-income setting. Not fit for a catalogue. Not fit for a high-income hospital. Fit for the facility where it will actually be used — evaluated independently, rigorously, and transparently across eight domains.
91
individual evaluation criteria
8
core assessment domains
1
independent unbiased standard
11
biomedical engineers and global health professionals
The evaluation framework
WHAT WE TEST
01 //
Maintenance
Can it be kept running by the people who will use it?
Internal design, PPM requirements, parts availability, tools, skills, diagnostics, and end-of-life planning — testing manufacturer claims against field reality.
02 //
Durability
Will it survive the environment where it is deployed?
Temperature, humidity, dust, voltage fluctuations, chemical exposure, and physical handling — tested against real LMIC conditions, not laboratory standards alone.
03 //
Usability
Can the right people use it correctly, without specialist training?
Interface clarity, language accessibility, error warnings, and setup without guidance — assessed with the actual users in mind, not those assumed by the device designer.
04 //
Infrastructure
Does it fit the facility — not just physically, but operationally?
Power demand, water, oxygen or suction dependencies, and installation — evaluated against the baseline infrastructure of a median district hospital in a target LMIC.
05 //
Cost
Is it affordable to buy, run, and maintain over its full lifetime?
Capital cost, consumables, spare parts, and total cost of ownership — benchmarked against realistic hospital budgets, not high-income procurement norms.
06 //
Compliance
Does it meet the standards that matter — and the right ones?
ISO 13485, IMDRF, CE, WHO prequalification, and equivalents — recognising that CE or FDA approval alone does not guarantee fitness for an LMIC regulatory environment.
07 //
Learning
Can users and maintainers access the knowledge they need?
Quick start guides, multilingual manuals, training videos — assessed for accessibility, clarity, and availability without additional cost to the facility.
08 //
Access
Can it actually be procured, delivered, and supported where needed?
Local distribution, importation expertise, legal barriers, service capacity, and response times — because a device that cannot be reliably supported is not a solution.
For procurement officers
8 QUESTIONS TO ASK
BEFORE YOU PROCURE
01 //
Can your team maintain it — without the manufacturer?
Ask for the maintenance manual. Ask whether generic spare parts are approved. Ask for a PPM kit and a clear procedure. If none of these exist, the device is not independently maintainable.
02 //
Will it survive your facility's power supply?
Surges, blackouts, brownouts, voltage variation, lack of grounding. Request test data — not just a voltage specification on a data sheet.
03 //
Can an untrained user set it up correctly?
The device should be interpretable without a manual. If it cannot be set up by a new staff member on a busy ward, it will not be used correctly under pressure.
04 //
What infrastructure does it require — and do you have it?
Piped oxygen, walled suction, cold chain, distilled water, site preparation. If any are uncommon in your facilities, confirm independence from them upfront.
05 //
What will it actually cost over its full lifetime?
Ask for a total cost of ownership estimate — consumables, spare parts, maintenance, and disposal — not just the purchase price on the proforma invoice.
06 //
Is it certified for use in your country — not just in Europe or the US?
CE and FDA clearance do not guarantee national regulatory approval. Confirm the device has or can obtain approval in your jurisdiction before procurement.
07 //
Are training materials freely accessible — in the right language?
Manuals only in English, locked behind registration, or requiring paid re-training are operational risks. Confirm accessibility before the order is placed.
08 //
Can you actually reach someone if something goes wrong?
Test the contact form. Ask for the local distributor. Request a reference from another facility in your region. Responsiveness before purchase predicts responsiveness after.
For procurement professionals
Download the full procurement checklist
A structured, field-ready checklist covering all 91 AME criteria across the eight domains — with evidence guidance and assessment instructions for independent use.
Download PDF →For manufacturers
Submit your device for AME evaluation
An AME label is an independent, evidence-based signal that your device is fit for LMIC deployment — recognised by procurement bodies, ministries of health, and international organisations.
Start the process →