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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.
Results for 13485
4 shown| Designation | Status | Source |
|---|---|---|
| ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes | Current 2016-02-25 | INTL · ISO |
| ISO 13485:2003/Cor 1:2009 Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1 Replaced by ISO 13485:2016 | Withdrawn 2009-07-17 | INTL · ISO |
| ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes Replaced by ISO 13485:2016 | Withdrawn 2003-07-03 | INTL · ISO |
| ISO 13485:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9001 Replaced by ISO 13485:2003 | Withdrawn 1996-12-26 | INTL · ISO |
In a workspace, one click adds any of these to your watchlist. Contains ISO Open Data, licensed under ODC-By 1.0 (iso.org/open-data).
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.
| 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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