ISO 6717:2021 PDF

In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood

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Title (English):

ISO 6717:2021

In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 14
Publication date:: August 26, 2021
Edition:: ISO IS 6717 edition 1 version 1
ICS:: 11.100.10

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Description (English):

This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations. Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples. Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs. NOTE Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710. This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.

Technical details

Technical committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
SKU: ISO 6717:2021

Abstract

Overview

ISO 6717:2021 - In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood - specifies requirements and test methods for specialized single-use evacuated and non-evacuated specimen containers (excluding blood). The standard covers primary containment and preservation of human-derived specimens for in vitro diagnostic (IVD) examination (e.g., CSF, urine, saliva, sputum, faeces, tissue samples, infected bodily fluids). It excludes forensic specimen containers, cryo‑preservation devices, samples for nucleic acid testing, swabs and auxiliary devices.

Key topics and technical requirements

Scope and definitions: Clear terms for container, receptacle, closure, evacuated container, draw volume, filling capacity, additive, etc.
Materials: Receptacle transparency when visual inspection is required; manufacturers must disclose potential elemental/substance interferences.
Filling capacity / draw volume:
- Non‑evacuated containers: water added must be within ±10% of the filling capacity (Annex A).
- Evacuated containers: water added must be within ±10% of the draw volume (Annex B); manufacturers must ensure accuracy throughout shelf life.
Graduation lines: Graduation accuracy must be between 90% and 110% of indicated volume (Annex A).
Design and construction:
- Closures must resist loosening and leakage (leak tests in Annex C).
- Containers intended for centrifugation must withstand 3 000 g or the manufacturer‑specified RCF without breaking or leaking (Annex D).
- Label durability, compatibility with automation/transport, and safe removal of closures are required.
Sterility and microbiological state: Sterilization is mandatory when the device contacts a patient fluid pathway, is intended for culture, or contains culture media; validated processes required.
Additives: Manufacturers must validate additive choice, efficacy, form and concentration; containers with additives require provisions for mixing.
Marking and labelling: Visibility of specimen, stability of labels across stated temperature ranges, and use of symbols (see ISO 15223-1) are addressed.

Applications and who uses this standard

ISO 6717:2021 is used by:

Manufacturers of single‑use specimen containers (design, production, labeling, test methods)
Regulatory and quality teams for compliance and technical documentation
Clinical laboratories and hospital procurement assessing container suitability for specific specimen types
Test laboratories performing conformity testing against Annex A–D methods
Device designers integrating containers with automation and transportation systems

Practical use cases include validating container draw/fill volumes, specifying closure performance, ensuring centrifuge compatibility, and documenting additive and sterility claims.

Related standards

ISO 6710 - requirements for single‑use human venous blood specimen containers
ISO 15223-1 - symbols for medical device labeling

Keywords: ISO 6717:2021, in vitro diagnostic medical devices, specimen containers, evacuated containers, non-evacuated containers, filling capacity, draw volume, additives, sterility, centrifugation, medical device labeling.

Related standards

Other ISO standards

Abstract

Overview

Key topics and technical requirements

Scope and definitions: Clear terms for container, receptacle, closure, evacuated container, draw volume, filling capacity, additive, etc.
Materials: Receptacle transparency when visual inspection is required; manufacturers must disclose potential elemental/substance interferences.
Filling capacity / draw volume:
- Non‑evacuated containers: water added must be within ±10% of the filling capacity (Annex A).
- Evacuated containers: water added must be within ±10% of the draw volume (Annex B); manufacturers must ensure accuracy throughout shelf life.
Graduation lines: Graduation accuracy must be between 90% and 110% of indicated volume (Annex A).
Design and construction:
- Closures must resist loosening and leakage (leak tests in Annex C).
- Containers intended for centrifugation must withstand 3 000 g or the manufacturer‑specified RCF without breaking or leaking (Annex D).
- Label durability, compatibility with automation/transport, and safe removal of closures are required.
Sterility and microbiological state: Sterilization is mandatory when the device contacts a patient fluid pathway, is intended for culture, or contains culture media; validated processes required.
Additives: Manufacturers must validate additive choice, efficacy, form and concentration; containers with additives require provisions for mixing.
Marking and labelling: Visibility of specimen, stability of labels across stated temperature ranges, and use of symbols (see ISO 15223-1) are addressed.

Applications and who uses this standard

ISO 6717:2021 is used by:

Manufacturers of single‑use specimen containers (design, production, labeling, test methods)
Regulatory and quality teams for compliance and technical documentation
Clinical laboratories and hospital procurement assessing container suitability for specific specimen types
Test laboratories performing conformity testing against Annex A–D methods
Device designers integrating containers with automation and transportation systems

Practical use cases include validating container draw/fill volumes, specifying closure performance, ensuring centrifuge compatibility, and documenting additive and sterility claims.

Related standards

ISO 6710 - requirements for single‑use human venous blood specimen containers
ISO 15223-1 - symbols for medical device labeling

ISO 6717:2021 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

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