Boston Scientific Spec Library
Locate the fields required to request the current SKU-, market-, and revision-specific record.
Minimum retrieval key by record type
Document availability and applicability vary by device, classification, indication, and destination market.
| Record | Required lookup fields | What to verify | Revision control |
|---|---|---|---|
| Instructions for Use | Commercial name, catalog number, language, market | Intended use, contraindications, setup, handling, warnings | Revision identifier and effective date |
| Regulatory summary | SKU / device family, indication, market | 510(k) substantial equivalence, premarket approval (PMA), or CE MDR route as applicable | Current status and product scope |
| Sterilization evidence | Packaging configuration, sterilization method, load family | Sterility assurance level (SAL), ethylene oxide sterilization residuals where applicable, package integrity, shelf life | Validation protocol / report reference |
| Biological evaluation | Material, contact type, contact duration | Biocompatibility testing and ISO 10993 endpoint rationale | Material and process revision linkage |
| Service record | Model, serial, installed configuration, site | Maintenance procedure, calibrated tool, test result, release | Device master record (DMR) and firmware version |
| Recall / field action | Unique device identification (UDI), UDI-PI, lot or serial, market | Affected population, adverse event reporting (MDR), action, reconciliation | Notice version and post-market surveillance (PMS) link |
Prepare a reproducible document request
- 01
Identify the exact device
Provide commercial name, catalog number, UDI-DI or GTIN, model, and configuration. A brand or family name by itself is insufficient.
- 02
Name the market and clinical use
State destination country or region, intended procedure, user type, and care setting so regulatory and language records can be matched.
- 03
Set the evidence question
Specify whether the review concerns risk-benefit analysis, reprocessing validation, sterility assurance, biocompatibility testing, software version, service, reimbursement, or field action.
- 04
Check controlled metadata
Confirm title, document number, revision, effective date, approval status, applicable SKUs, and superseded version before relying on a file.
- 05
Reproduce the verification path
For acceptance testing, record the environment, sample or device identity, method, acceptance criterion, observed result, deviation, and reviewer.
Technical limits to keep visible
Published specifications may describe nominal or tested conditions rather than every installed condition. Sterilization data applies specifically to the validated product and package configuration. Software compatibility changes by released version. Pricing and service response depend on contract, geography, and scope. Reconcile the retrieved file against the delivered SKU and current IFU.
Request the controlled record
Include the five retrieval keys above; omit patient-identifiable information.