ISO 20184-2-2018 PDF

Full title and description

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins. This international standard provides guidance and requirements for the handling, documentation, storage and processing of frozen tissue specimens when the intended downstream molecular examination targets isolated proteins.

Abstract

ISO 20184-2:2018 specifies requirements and gives recommendations for the pre‑examination phase for frozen tissue samples intended for protein analysis. It addresses chain of custody, specimen collection and transport, freezing and storage conditions, sample reception and tracking, procedures for isolation of protein analytes, assessment of protein quality/quantity, labelling and archiving, and validation/verification activities relevant to molecular in vitro diagnostic examinations that evaluate proteins isolated from frozen tissue.

General information

• Status: Published (International Standard, confirmed)
• Publication date: November 2018 (first edition published in early November 2018)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.100.10 — In vitro diagnostic test systems
• Edition / version: 1st edition (2018)
• Number of pages: 17

Scope

Applies to the pre‑examination phase for frozen tissue specimens destined for molecular IVD procedures that analyze isolated proteins. The standard covers the steps from sample collection and transport through laboratory reception, freezing, protein isolation, quality assessment and storage of both tissue and isolated protein analytes. It is intended for medical laboratories, molecular pathology laboratories, biobanks, IVD developers and manufacturers, research organizations and regulatory authorities. Specimens that have undergone chemical stabilization prior to freezing are outside the scope.

Key topics and requirements

• Specimen identification, traceability and documentation requirements for frozen tissue intended for protein analysis.
• Requirements and recommendations for transport and handling prior to freezing (containers, temperature control, timing).
• Freezing and storage conditions to preserve protein integrity (cold ischemia considerations, preferred freezing approaches).
• Procedures for reception, logging and acceptance/rejection criteria at the laboratory.
• Guidance on isolation of proteins from frozen tissue and recommended controls for process integrity.
• Methods for assessing protein quality and quantity and criteria for suitability for downstream molecular assays.
• Requirements for labelling, aliquoting, archiving and long‑term biobank storage of tissue and isolated proteins.
• Validation and verification activities for pre‑examination procedures, equipment and workflows.
• Recommendations on risk management, contamination avoidance and personnel competence.

Typical use and users

Used by clinical and molecular pathology laboratories performing protein‑based molecular diagnostics, hospital pathology services, diagnostic test developers and manufacturers, biobanks that store frozen tissue for proteomic analysis, contract research organizations, and regulatory bodies assessing preanalytical quality. Also referenced by laboratory quality managers when writing procedures and training for pre‑analytical workflows.

Related standards

ISO 20184-2 is part of the ISO 20184 series for frozen tissue pre‑examination processes (see ISO 20184-1:2018 — Part 1: Isolated RNA; ISO 20184-3:2021 — Part 3: Isolated DNA). It aligns with general laboratory quality and preanalytical requirements such as ISO 15189 (medical laboratory quality and competence) and with related ISO 20186 series documents addressing venous whole blood pre‑examination processes. Earlier technical specifications such as CEN/TS 16826-2:2015 were superseded by this publication in some regions.

Keywords

pre‑examination; preanalytical; frozen tissue; isolated proteins; molecular in vitro diagnostic; biobank; specimen transport; freezing; protein isolation; validation; ISO/TC 212

FAQ

Q: What is this standard?

A: ISO 20184-2:2018 is an international standard that specifies requirements and gives recommendations for pre‑examination processes for frozen tissue samples when the analyte of interest is isolated protein.

Q: What does it cover?

A: It covers specimen collection and transport to freezing, freezing and storage conditions, laboratory reception and tracking, procedures for isolating protein analytes, quality/quantity assessment of proteins, archiving, labelling and the validation/verification of pre‑analytical workflows.

Q: Who typically uses it?

A: Clinical laboratories, molecular pathology services, biobanks, IVD test developers and manufacturers, research institutions, contract labs and regulatory authorities involved in protein‑based molecular diagnostics.

Q: Is it current or superseded?

A: ISO 20184-2:2018 is a current published international standard (first edition, published November 2018). Users should check national/adopted versions or later revisions for any updates applicable in their jurisdiction.

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 20184 series for frozen tissue pre‑examination processes. Companion parts include ISO 20184-1 (Isolated RNA) and ISO 20184-3 (Isolated DNA); related series include ISO 20186 for venous whole blood pre‑examination.

Q: What are the key keywords?

A: Pre‑examination, frozen tissue, isolated proteins, preanalytical, molecular diagnostics, biobanking, specimen transport, freezing, protein quality, ISO 20184.