Search the registry your workspace uses
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 14971
7 shown| Designation | Status | Source |
|---|---|---|
| ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices | Recognized 2019-12-23 | US · FDA 5-125 |
| ISO 14971:2019 Medical devices — Application of risk management to medical devices | Current 2019-12-10 | INTL · ISO |
| ISO 14971:2007 Medical devices — Application of risk management to medical devices Replaced by ISO 14971:2019 | Withdrawn 2007-02-28 | INTL · ISO |
| ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements Replaced by ISO 14971:2007 | Withdrawn 2003-02-19 | INTL · ISO |
| ISO 14971:2000 Medical devices — Application of risk management to medical devices Replaced by ISO 14971:2007 | Withdrawn 2000-11-30 | INTL · ISO |
| ISO 14971-1:1998 Medical devices — Risk management — Part 1: Application of risk analysis Replaced by ISO 14971:2000 | Withdrawn 1998-10-01 | INTL · ISO |
| ISO/PWI 14971-B Medical devices — Application of risk management to medical devices — Part B: In vitro diagnostic medical devices | unknown | 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.
Run it on your products
Upload PDFs, including scans, get gap reports in Excel or Word, and watch the standards you work to.