Identity
Preserve patient, container, aliquot, rack, instrument and result linkage.
Real-work map · 12
Laboratory automation
Evaluate sample identity, contamination control, assay timing, exception handling and result release—not motion alone.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
12
FUURAA thesis
Laboratory robotics creates value when every sample remains attributable and every exception is recoverable.
Engineering map
Turn the title into engineering objects that can be observed, measured and reviewed.
Each layer states the boundary to establish and the evidence needed for the next decision.
Process
Control volume, timing, temperature, mixing, carryover and contamination.
Exception
Quarantine ambiguity, preserve evidence and require authorised disposition.
Verification questions
Write the questions first, then decide whether a demo, test, pilot or operating record can answer them.
Each question needs an object, conditions, denominator, threshold and accountable decision owner.
- 01
Can every result trace to the original sample?
- 02
How are partial failures quarantined?
- 03
What prevents silent carryover?
- 04
Who releases recovered results?
Evidence to preserve
Enable the next reader to reconstruct conditions, results, failures and the decision.
A conclusion alone loses reviewability; raw records, configuration and exclusions matter too.
- 01
Evidence package 1
Chain-of-custody and process map
- 02
Evidence package 2
Carryover, contamination and timing validation
- 03
Evidence package 3
Exception and result-release record
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Robotic throughput does not establish analytical validity, clinical validity or result integrity.
- 02
This is an engineering reading and decision framework; it does not replace application-specific risk assessment, conformity work, procurement acceptance or professional advice.
Sources and evidence status
Read standards scope, measurement evidence and application conclusions separately.
Source dates and review status remain visible; external sources open in a new tab.
01
ISO · Published 2016-03 · confirmed 2025
↗02ISO 13485:2016 — Medical-device quality management systems
Sets quality-system requirements for organisations involved in design, production, installation and servicing of medical devices.
ISO · Published 2019-12 · current edition verified 2026-08-15
↗03ISO 14971:2019 — Medical-device risk management
Specifies a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk and monitoring control effectiveness.
Beijing Medical Products Administration · Published 2025-04-03
↗2025 inspection guide for surgical-robot manufacturing quality management
Details expectations spanning design, algorithms, assembly, software installation, inspection, supplier control, maintenance and after-sales capability.