The Benchmark
Eight criteria. One score out of 100. Use it to evaluate any honey-based medical product on the market — Manuka, peroxide-active or polyphenol-rich. Built from regulatory practice (MDR, FDA 510(k), TGA), monofloral standards (MPI for Manuka, equivalent process controls for non-Manuka), and the wound-care evidence base.
At a glance
| # | Criterion | Weight |
|---|---|---|
| 01 | Verified botanical identity | 15 |
| 02 | Quantified activity with stability data | 15 |
| 03 | Validated sterilisation | 15 |
| 04 | Documented bioburden specification | 10 |
| 05 | Regulatory route on file | 15 |
| 06 | Quality system | 10 |
| 07 | Claims discipline | 10 |
| 08 | Independent clinical evidence | 10 |
| Total | 100 / 100 |
The detail
01
Weight 15
Documented monofloral or controlled-floral source — DNA, pollen, marker chemistry or greenhouse process — so the activity driver is known.
02
Weight 15
A declared, batch-tested activity marker appropriate to the honey — MGO (mg/kg) for Leptospermum; NPA / phenol-equivalent or H₂O₂ release for peroxide-active honeys; total phenolic content for polyphenol-driven honeys — with a documented stability curve over shelf life.
03
Weight 15
Gamma or e-beam at a dose validated against pre-sterilisation bioburden — heat-pasteurised honey is not medical grade.
04
Weight 10
Pre-sterilisation bioburden limit appropriate to route of administration.
05
Weight 15
A live regulatory pathway for the intended use — not a food licence repurposed.
06
Weight 10
Manufacture under a recognised medical-device QMS.
07
Weight 10
On-pack claims map to debridement, moist healing, malodour and pH; antimicrobial language confined to off-pack literature.
08
Weight 10
Peer-reviewed studies — ideally RCTs or systematic reviews — covering the indication on the label.
Scoring
Scoring scheme
Sum across all eight criteria for a 0–100 score. We classify ≥ 80 Reference Grade, 60–79 Compliant, 40–59 Marginal, < 40 Not Medical Grade.
Interpretation
The Benchmark is intentionally strict on regulatory and sterilisation criteria — that is where most products fail despite high . A 900+ MGO honey pasteurised under a food licence still scores below an MGO 400 dressing manufactured under with and a CE file.
Independently maintained. Updated as the regulatory and evidence base evolves.
Cite this rubric
MedicalGradeHoney.com (2026). The Medical Grade Honey Benchmark — an 8-criteria scorecard. medicalgradehoney.com/benchmark