"Sample" is for measurement, "specimen" is for collection. "Primary sample" is misleading.

ISO/TC 212 WG1 started the activity “13.3 Harmonization of terminology across ISO TC212”

CLSI changed all titles related to collection from “primary samples” to “specimen”.

ISO/DIS 15189 has 6.3.5 “Specimen collection facilities”

ISO 6717:2021 has: “3.17 specimen… [SOURCE: ISO 15189:2012, 3.16, modified – the preferred term 'primary sample' has been deleted.]”

ISO 20916:2019 3.47 specimen … [SOURCE:ISO 18113-1:2009, 3.54, modified — “Specimen” is the first preferred terms,

The International Medical Device Regulators Forum (IMDRF) uses the term specimen. ¹ WHO uses the term “specimen”. ² CLSI in many documents uses the term “specimen”. ³ ILAC uses the term “specimen” in G18 and G26. ⁴

CDC uses the term “specimen”.⁵ ISO itself in several documents uses the term specimen even in the title.⁶

Therefore, "specimen” is the standard term in collection activities. “primary sample” is little more than a form of "slang"and can cause confusion with other terms.

“sample” retains its value for statistical and measurement activities.

1Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. Authoring Group: IMDRF IVD Working Group. Date: 21 January 2021 Common Data Elements for Medical Device Identification. Authoring Group: IMDRF RPS Working Group. Date: 24 March 2016 GHTF SG5 Clinical Performance Studies for IVD Medical Devices

GHTF SG1 - Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices - 17 March 2011

GHTF SG1 - Principles of Safety and Performance of Medical Devices - May 2005

Glossary and Definitions of Terms Used in GHTF Documents

GHTF SG1 Definition of the Terms Medical Device' and In Vitro Diagnostics' Medical Device's

2World Health Organization. Regional Office for the Eastern Mediterranean. (‎1995)‎. Specimen collection and transport for microbiological investigation. https://apps.who.int/iris/handle/10665/119529 WHO Procedures for collection of clinical specimens (blood sample) during field investigation of suspected outbreaks. https://www.who.int/csr/resources/publications/ebola/blood-collect-en.pdf WHO/CDS/CSR/EDC/2000.4 Guidelines for the collection of clinical specimens during field investigation of outbreaks. https://apps.who.int/iris/bitstream/handle/10665/66348/WHO_CDS_CSR_EDC_2000.4.pdf?sequence=1

3EP35 Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline AUTO01-A Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard

AUTO02-A2 Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard—Second Edition

AUTO07-A Laboratory Automation: Data Content for Specimen Identification; Approved Standard

AUTO12-A Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard

GP23-Ed2 Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes, Second Edition

GP34-A Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline

GP39-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition

GP41-Ed7 Collection of Diagnostic Venous Blood Specimens, Seventh Edition

GP42-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard—Sixth Edition

GP44-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline—Fourth Edition

H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition

M54-A Principles and Procedures for Detection of Fungi in Clinical Specimens—Direct Examination and Culture; Approved Guideline

MM13-A Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline

4ILAC G26:11/2018 Guidance for the Implementation of a Medical Accreditation Scheme ILAC G18:04/2010 Guideline for the Formulation of Scopes of Accreditation for Laboratories

5CDC. Specimen Collection Guidelines. https://www.cdc.gov/urdo/downloads/speccollectionguidelines.pdf CDC. Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing. Updated Feb. 26, 2021. https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html Submitting Specimens to CDC. https://www.cdc.gov/laboratory/specimen-submission/list.html

6ISO (revised)

ISO 20916, In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

ISO/DIS 4307 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA (14 recurrences)

ISO 6710:2017 Single-use containers for human venous blood specimen collection

ISO/FDIS 6717 In Vitro Diagnostic Medical Devices — Single-Use Containers For The Collection Of Specimens From Humans Other Than Blood

ISO 14971:2019 Medical devices — Application of risk management to medical devices. 3.7 3.10

ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards. 3.9 3.12

ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. Scope, 3.21

ISO 17822:2020 In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide. 3.30, 3.22,

ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements. 3.2

ISO 23640:2011 In Vitro Diagnostic Medical Devices — Evaluation Of Stability Of In Vitro Diagnostic Reagents. Scope, 3.6

ISO 21474-1:2020 In Vitro Diagnostic Medical Devices — Multiplex Molecular Testing For Nucleic Acids — Part 1: Terminology And General Requirements For Nucleic Acid Quality Evaluation. Introduction, 3.39

ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards. 3.10, 3.13,

ISO 20184-1:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 1: Isolated RNA. Introduction, 3.12

ISO 20184-2:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 2: Isolated proteins. Introduction, 1 Scope, 3.8

ISO 20186-2:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA. Introduction, 3.18 Note1 and Note 2.

ISO 20186-3:2019 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 3: Isolated circulating cell free DNA from plasma. Introduction, 3.21.

ISO 20166-1:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA. Introduction, 1 Scope, 3.13, 3.14.

ISO 20166-2:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins. Introduction, 1 Scope, 3.10,

ISO 20166-3:2018 Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA. Introduction, 3.12.

ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

ISO 22367:2020 Medical laboratories — Application of risk management to medical laboratories. 3.10,

ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents. 1 Scope, 3.6,  

CEN

FprCEN/TS 17742:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma. 1 Scope

FprCEN/TS 17747:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - DNA, RNA and proteins. "specimen" 50 recurrences

HL7

HL7 FHIR (Fast Healthcare Interoperability Resources). 10.7 Resource Specimen - Content. http://www.hl7.org/fhir/specimen.html