DIN EN ISO 6717 2021-12 PDF

Full title and description

STB DIN EN ISO 6717:2021-12 — In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood. This designation refers to the DIN (German) / EN adoption (December 2021) of ISO 6717:2021 and the corresponding national/adopted texts used for conformity and procurement in Europe.

Abstract

This standard specifies requirements and test methods for specialised single‑use evacuated and non‑evacuated specimen containers intended as the primary containment and for preservation of human specimens other than blood for in vitro diagnostic examination. It gives examples of covered specimen types (for example cerebrospinal fluid, faeces, infected body fluids, saliva, sputum, urine, tissue samples) and lists specific exclusions (for example containers for cryopreservation, samples for nucleic acid testing and swabs). It does not cover forensic specimen containers or auxiliary devices used with specimen containers. The DIN/EN adoption (DIN EN ISO 6717:2021-12) implements the international ISO text for use in national/regional applications.

General information

• Status: Published / Current (national adoption of ISO 6717:2021).
• Publication date: DIN EN ISO adoption: 1 December 2021 (ISO original publication: 26 August 2021).
• Publisher: ISO (original); adopted and published nationally as DIN EN ISO 6717 by Deutsches Institut für Normung (DIN) / CEN adoption channels.
• ICS / categories: 11.100.10 — In vitro diagnostic systems.
• Edition / version: Edition 1 (ISO 6717:2021) — DIN EN ISO 6717:2021-12 (national adoption, December 2021).
• Number of pages: Typically 14 pages for the ISO original; the DIN/EN adopted German-language publication is commonly issued as 22 pages (formatting and national front matter may vary).

Scope

The standard applies to specialised single‑use containers (evacuated and non‑evacuated) intended by manufacturers for primary containment and preservation of human specimens other than blood for in vitro diagnostic (IVD) testing. It defines essential requirements, performance and safety-related tests for those containers, clarifies specimens and device types explicitly excluded, and aligns terminology and test methods with related IVD container standards. It is intended for manufacturers, conformity assessment bodies and laboratories involved in IVD specimen collection, packaging and transportation.

Key topics and requirements

• Definitions and classification of single‑use specimen containers (evacuated vs non‑evacuated).
• Essential design and material requirements to ensure primary containment and specimen integrity for IVD use.
• Performance test methods (e.g., leak tightness, closure integrity, vacuum stability for evacuated systems, dimensional and labeling requirements as applicable).
• Requirements for preservation and compatibility with common specimen types (CSF, urine, sputum, faeces, saliva, tissue, etc.).
• Specified exclusions (containers for cryopreservation, nucleic acid testing sample containers, and swabs are excluded).
• Marking, labelling and documentation expectations to support traceability and safe handling.
• Normative references and alignment with other ISO/CEN documents for blood-collection containers (see related standards).

Typical use and users

Used by manufacturers of single‑use specimen containers, medical device designers, regulatory and conformity-assessment bodies, clinical and diagnostic laboratories, hospital procurement departments, and quality managers responsible for specimen collection and transport. The standard guides product design, conformity demonstration, test laboratories performing performance verification, and purchasers specifying container requirements for IVD specimen workflows.

Related standards

Relevant related documents include ISO 6710 (requirements for single‑use human venous blood specimen collection containers), the replaced DIN EN 14254:2004-09 (superseded by this adoption), and other ISO/CEN standards and guidance covering labelling, transport of biological samples, and IVD device risk/safety requirements. National EN adoptions (for example DIN EN ISO 6717, BS EN ISO 6717, ÖNORM EN ISO 6717, STN EN ISO 6717) provide language- and market-specific publications.

Keywords

single-use containers, specimen containers, in vitro diagnostic (IVD), evacuated container, non-evacuated container, specimen preservation, containment, ISO 6717, DIN EN ISO 6717, specimen collection, laboratory consumables.

FAQ

Q: What is this standard?

A: ISO 6717:2021 (published as national/adopted texts such as DIN EN ISO 6717:2021-12) is an international standard that specifies requirements and test methods for specialised single‑use containers used to collect and preserve human specimens other than blood for in vitro diagnostic testing.

Q: What does it cover?

A: It covers design, material and performance requirements and associated test methods for evacuated and non‑evacuated single‑use specimen containers intended as the primary containment for specimens such as CSF, urine, sputum, faeces, saliva and tissue samples. It explicitly excludes certain device types (for example cryopreservation containers, samples intended specifically for nucleic acid testing, and swabs) and does not address forensic containers or many auxiliary devices.

Q: Who typically uses it?

A: Manufacturers of specimen containers and diagnostic consumables, test laboratories performing verification, regulatory and conformity-assessment bodies, hospital and clinical laboratory procurement and quality teams, and designers of IVD specimen-collection systems.

Q: Is it current or superseded?

A: This edition (ISO 6717:2021) was published in 2021 and adopted in national/EN texts in late 2021 (for example DIN EN ISO 6717:2021-12 published 1 December 2021). It replaced earlier national standards such as DIN EN 14254:2004-09 for the covered subject matter. As of 24 February 2026 there is no widely published revision superseding ISO 6717:2021; users should check their national standards body catalogue for any amendments or withdrawals applicable to their market.

Q: Is it part of a series?

A: It is related to a family of standards dealing with specimen collection and in vitro diagnostic devices — for example ISO 6710 (blood specimen containers) and other ISO/CEN documents on labelling and medical device requirements. National and regional EN adoptions create harmonised publications for specific markets.

Q: What are the key keywords?

A: single-use containers, specimen containers, in vitro diagnostic, evacuated container, non-evacuated container, specimen preservation, containment, ISO 6717, DIN EN ISO 6717.