Free guide · ISO 20658
Pre-analytical phase · EN ISO 20658:2023

Achieve compliance ISO 20658

Up to 68,2% of laboratory errors occur in the pre-analytical phase. Our practical guide shows you how to standardize sample collection and transport to the standard EN ISO 20658 — identification, labeling and traceability — without disrupting your lab's processes.

68,2%of errors in the pre-analytical phase
< 2 weeksup and running in the lab
100%sample traceability
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SynlabRocheBeckman CoulterLabor BerlinKBC RijekaHaemalab FreisingHospital de Olot

68.2% of errors start before the lab

Problems start at order entry, in sample non-conformities, in transport delays and in the lack of cold-chain control. Most are discovered only after analysis — too late to avoid repeats, clinical delays and extra costs.

The standard ISO 20658:2023 defines requirements and good practice for sample collection and transport. S4DX covers them end-to-end, from collection to receipt.
68,2%Pre-analytical phase
collection, transport, order entry
23%Post-analytical phase
reporting
9%Analytical phase
analyzer, reagents

From collection to receipt, a single tracked flow

Every sample has a digital fingerprint: S4DX follows it end-to-end, generating the data ISO 20658 requires at every step.

01

Pre-collection

Unambiguous patient/sample identification and pre-analytical guidance, right from the request.

02

Collection

Record operator, date and time; the SmartTube starts monitoring temperature and shocks.

03

Transport

Temperature and times monitored in transit; alerts if integrity is compromised.

04

Receipt

Automatic receipt, acceptance/rejection flags and end-to-end traceability through to the report.

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An expert shows you how to reach ISO 20658 compliance with S4DX — step by step, no commitment.

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Pre-analytical compliance, without the complexity

End-to-end traceability

From collection to delivery in the lab, every sample is recorded, monitored and verified in real time. Full chain of custody.

ISO 20658 requirements covered

A complete, auditable trail for every sample, from collection to transport, compliant with EN ISO 20658:2023.

More predictable TAT

Fewer repeats and fewer hours spent chasing samples. A measurable, defensible turnaround time, backed by data.

Patient safety

Every clinical decision rests on a sample whose quality is verifiable from the first second. No ghost samples.

The ISO 20658:2023 requirements S4DX covers

ISO 20658 defines sample collection and transport for laboratory examinations. S4DX generates the data and traceability required across every area.

Identification

Patient identification

Correct patient identification and an unambiguous link to the sample.

S4DX: an unambiguous patient/sample link right from the request.
Collection

Sample collection

Collection procedures, correct containers, order, and recording of operator, date and time.

S4DX: records who, when and how, with conditions (temperature, shocks) from the very first moment.
Labeling

Labeling and handling

Unambiguous labeling and sample handling that preserves integrity.

S4DX: every sample has a traceable digital identity, verifiable at every step.
Transport

Transport and traceability

Controlled transport conditions and times, with traceability across the whole chain.

S4DX: monitors temperature and times in transit and flags if integrity is compromised.

Certified quality and security

Made in Germany & Made in Europe
Made in Germany & Europe — hardware and software built and supported in the EU
DIN EN ISO 9001:2015 — quality management system
DIN ISO/IEC 27001:2022 — information security
Data encrypted on EU servers — compliant with ISO 20658 and GDPR requirements
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With the S4DX sample tracking system we save up to 6 hours a day of administrative work in our laboratory.

Jürgen Weghofer
COO, Synlab Austria