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26,520 current ISO publications, 5,220 drafts and 1,738 FDA-recognized standards, with every replaced edition traced to its successor. Below the search is a sample assessment you can download.
Sample assessment
automated upper-arm blood-pressure monitor
Reusable, non-invasive, battery-powered oscillometric monitor with an inflatable arm cuff and a companion app over Bluetooth. Home and clinical use, adults. Sold in the US and EU.
EU · Regulation (EU) 2017/745 (MDR)
Class IIa (Annex VIII, Rule 10 — active device for diagnosis/monitoring)
US · 21 CFR 870.1130 — non-invasive blood pressure measurement system
Class II, 510(k)
| Standard | Title | Why it applies |
|---|---|---|
| IEC 60601-1 | Medical electrical equipment — basic safety and essential performance | Electrically powered device |
| IEC 60601-1-2 | Electromagnetic disturbances (EMC) | Electronics + Bluetooth radio |
| IEC 60601-1-11 | Home healthcare environment | Intended for home use |
| IEC 80601-2-30 | Automated non-invasive sphygmomanometers | Particular standard for this device type |
| ISO 81060-2 | Clinical investigation of intermittent automated measurement type | Clinical validation of accuracy |
| ISO 14971 | Application of risk management to medical devices | All medical devices |
| IEC 62304 | Medical device software — life cycle processes | Embedded firmware + app |
| IEC 62366-1 | Usability engineering | Lay users at home |
| ISO 10993-1 | Biological evaluation — evaluation and testing | Cuff in contact with intact skin |
| ISO 15223-1 | Symbols for labels and information | Labeling |
Sample output for an illustrative product, not advice for any real device. In a workspace the Advisor asks about your product first, shows the reason and confidence for every item, and a named reviewer signs off each decision.
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