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STANDARD

Current

ÖNORM EN ISO 6717

Issue date: 2021 12 15

In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

This document specifies requirements and test methods for specialized single-use evacuated and nonevacuated 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. This documnt does not specify requirements for auxiliary devices used in conjunction with specimen containers.

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General information on ÖNORM EN ISO 6717

Format

Digital | 19 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 6717 from 2004 til today.

• ÖNORM EN ISO 6717

  2021 12 15 Standard ÖNORM EN ISO 6717, Edition: 2021 12 15

  In vitro diagnostic medical devices - Single-use containers for the collection of specimens from hum...
• ÖNORM EN 14254

  2004 09 01 Standard ÖNORM EN 14254, Edition: 2004 09 01

  In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other ...

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Frequently Asked Questions about ÖNORM EN ISO 6717

What is a "Single-User Licence"?

When you purchase a standard from the Austrian Standards webshop (e.g. ÖNORM, ISO), a single-user licence is included as standard. This entitles a single person to use the standard. A multi-user licence is required if several employees need access. It enables company-wide, legally compliant use and sharing of standards.

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How can I get involved in the further development of this standard?

Standardization thrives on expertise and participation. Anyone interested can play an active role in its further development – for example, by joining the relevant committee or a working group. In this way, you can help shape the content and contribute to advancing the state of the art.

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 15223-1:2021	Titel Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (Corrected version 2021-07)	Ausgabedatum 2021 07 06	Art Standard	Zur Produktseite

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