Status: frozen
36 of 86 tracked instruments.
This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.
Status unknown 6 frozen 36 (active — select again to clear) draft 3 final 31 in-force 10
Ordered by the lifecycle the values themselves name.
Jurisdiction International 21 EU 5 US 5 UK 1 Australia 1 Brazil 1 Japan 1 Switzerland 1
Ordered by count, then alphabetically.
Subject (as stated) no self-stated subject 16 artificial intelligence 3 software 4 medical devices 3 security 4 computerised systems 3 manufacturing 1 risk management 1
+5 more
data integrity 1 information security 3 quality management 2 trustworthiness 2 good manufacturing practice 1Values match by containment: a document stating "information security" appears under "security", because one string contains the other and no mapping between words is applied.
Class (as stated) no self-stated class 17 consensus standard 14 authority guidance 5
The words a document uses about itself. One that uses none is filed under "no self-stated class" — a fact about the reading, not a kind of document.
Two facets compose at a time.
Showing 36 of 86 instruments. Clear all filters
| Instrument | Authority | Jurisdiction | Status | Last verified | Last changed | Source |
|---|---|---|---|---|---|---|
| ANVISA | Agência Nacional de Vigilância Sanitária | Brazil | not yet verified frozen listing only | — | — | link (opens in new tab) |
| ASTM E2537 | ASTM International | International | final tool-read paywalled — progression tracked | 2026-07-31 | — | link (opens in new tab) · retrieved |
| CEN/CLC JTC 21 | CEN/CENELEC | EU | not yet verified frozen not a document | — | — | link (opens in new tab) |
| DI revision concept paper | European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
| FDA AI device list | US Food and Drug Administration | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| FDA ETP | US Food and Drug Administration | US | not yet verified frozen not a document | — | — | link (opens in new tab) |
| FDA guidance agenda | US Food and Drug Administration | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| GAMP 5 2nd Ed | ISPE | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| GAMP AI Guide | ISPE | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| IEC 62304 | ISO/IEC | International | final tool-read paywalled — progression tracked | 2026-07-31 | — | link (opens in new tab) · retrieved |
| IEC 62443 | IEC / ISA | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| IMDRF AI/ML WG | International Medical Device Regulators Forum | International | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| IMDRF SaMD | International Medical Device Regulators Forum | International | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| ISO 13485 | ISO/IEC | International | final tool-read paywalled — progression tracked | 2026-07-31 | — | link (opens in new tab) · retrieved |
| ISO 14971 | ISO/IEC | International | final tool-read paywalled — progression tracked | 2026-07-31 | — | link (opens in new tab) · retrieved |
| ISO/IEC 27001 | ISO/IEC | International | final verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| ISO/IEC 27002 | ISO/IEC | International | final verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| ISO/IEC 27017 | ISO/IEC | International | withdrawn verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| ISO/IEC 27018 | ISO/IEC | International | withdrawn verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| ISO/IEC SC 42 | ISO/IEC | International | not yet verified frozen not a document | 2026-07-31 | — | link (opens in new tab) · retrieved |
| ISPE Pharma 4.0 | International Society for Pharmaceutical Engineering | International | not yet verified frozen not a document | — | — | link (opens in new tab) |
| MHRA AI Airlock | Medicines and Healthcare products Regulatory Agency | UK | not yet verified frozen not a document | 2026-07-31 | — | link (opens in new tab) · retrieved |
| NIST agent standards | US National Institute of Standards and Technology | US | not yet verified frozen not a document | — | — | link (opens in new tab) |
| NIST AI RMF Playbook | US National Institute of Standards and Technology | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| PIC/S Annex 11 | Pharmaceutical Inspection Co-operation Scheme | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
| PIC/S GMP Guide | Pharmaceutical Inspection Co-operation Scheme | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| PIC/S PI 041 | Pharmaceutical Inspection Co-operation Scheme | International | final verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| PMDA AI | Pharmaceuticals and Medical Devices Agency | Japan | not yet verified frozen listing only | — | — | link (opens in new tab) |
| prEN 18229-1 | CEN/CENELEC JTC 21 | EU | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| prEN 18229-2 | CEN/CENELEC JTC 21 | EU | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| prEN 18281 | CEN/CENELEC JTC 21 | EU | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| prEN 18282 | CEN/CENELEC JTC 21 | EU | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| Swissmedic | Swissmedic | Switzerland | not yet verified frozen listing only | — | — | link (opens in new tab) |
| TGA SaMD | Therapeutic Goods Administration | Australia | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| WHO computerised systems | World Health Organization | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
| WHO data management | World Health Organization | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
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