DSF/prEN ISO 6717 ( Forslag )

In vitro-diagnostisk medicinsk udstyr – Engangsbeholdere til prøveopsamling af andre humane prøver end blod


Status:
Forslag
Type:
Standard
Sprog:
Engelsk
Kategori:
Revision af:
Pris fra:
kr. 202,00
Lovgivning:

Beskrivelse

This standard specifies requirements and test methods for single-use evacuated and non-evacuated

receptacles, 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.



NOTE 1 – Requirements and test methods for evacuated and non-evacuated single-use venous blood

specimen containers are specified in EN ISO 6710.



NOTE 2 – While it is desirable that specimen receptacles should be designed to avoid spontaneous

discharge of the contents, when being opened, this standard does not specify a test procedure for this

because it has not been possible to devise an objective and reproducible test.



This standard does not specify requirements for collection needles or needle holders or other

accessories used in conjunction with specimen receptacles.


Antal sider: 20

Internationale relationer : prEN ISO 6717 IDT ISO/DIS 6717 IDT

ICS: 11.100.10 - In vitro-diagnostiske testsystemer

Varenummer: M345102


Udvalg og komiteer

Komite

  • CEN/TC 140
  • ISO/TC 76
  • ISO/TC 76/WG 1

Dansk udvalg

DS/S-260