ISO 24603, MISEV2018, and the national guideline: what each does for your COA
Three frameworks come up in exosome diligence. They do different jobs.
ISO 24603 covers cell-based extracellular vesicles for research use: biogenesis, isolation and characterization requirements for EVs derived from cultured cells. If your supplier's material is research-grade and cell-derived, ISO 24603 is the relevant production-and-characterization reference.
MISEV2018 is the International Society for Extracellular Vesicles' position paper: it defines how EV studies should be characterized — orthogonal methods for particle characterization, cargo and impurity reporting, no single-method claims. It is not a product standard — it defines how a credible COA reports its methods.
National measurement guidelines — in China, the Guide to Exosome Particle Size and Concentration Measurement (2026 No. 17; TONGNIAN is a drafting organization) anchors the release testing itself: how size and concentration are measured for batch release.
The practical map for buyers: production reference (ISO 24603), characterization language (MISEV2018), release testing (national guideline). A COA that cites all three anchors can be compared line-for-line across suppliers.
TONGNIAN COAs name methods against all three anchors — request a sample COA.
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