SPEC LIBRARY
Spec Library & Compliance Index
Audited document retrieval only. Provide the exact analyzer or monitor reference before requesting IFU, manuals or controlled disclosures.
STRUCTURED RETRIEVAL TABLE
Document request fields by year of revision control.
Values illustrate the index structure used for internal document control (revision years 2022–2024). Always confirm the current revision for your market, serial configuration and UDI-DI. Throughput (tests/hour), SpO2 accuracy bands, LOD/CV fields and cleared indications live inside the IFU—not in this index summary.
| Document class | 2022 | 2023 | 2024 | Target current |
|---|---|---|---|---|
| IFU / operator manuals indexed | 412 | 448 | 486 | Market-current only |
| Assay / reagent inserts linked | 1,180 | 1,240 | 1,310 | Lot-matched |
| DICOM / HL7 / FHIR statements | 36 | 41 | 47 | Interface-validated |
| Cybersecurity packets (SBOM / MDS²) | 18 | 24 | 31 | On request |
| Service methodology packs | 12 | 14 | 16 | Tier-specific |
COMPLIANCE CHECKLIST
Confirm which signal applies to your SKU.
- ✔ FDA Establishment registration context available on controlled request
- ✔ ISO 13485:2016 quality management system certificate
- ✔ ISO 14001:2015 environmental management (where site-certified)
- ✔ ISO 50001:2018 energy management (where site-certified)
- ✔ RoHS Directive 2011/65/EU product declarations where applicable
- ✔ REACH SVHC review status for relevant materials
- ✔ WEEE take-back pathway for eligible electronic instruments
- ✔ IEC 60601 / IEC 62304 / cybersecurity documentation for networked systems
- ✔ HL7 FHIR / DICOM / LIS interface statements when the SKU is networked
- ✔ CLIA complexity and assay package inserts for IVD configurations
Checklist items are retrieval cues. They do not replace product-specific labeling, 510(k) summaries or market registrations. Selection trade-off: request core-lab IFUs when you need overnight menu breadth and QC traceability; request POCT / near-patient packets only when minute-scale TAT is the primary criterion—and never mix the two claim sets.
Download the document index CSV template
Include model, UDI-DI, market and document class so the correct controlled file can be located.
Download CSV / Request Index