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

SS-EN-ISO-6717 - 2021 EDITION - CURRENT


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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.

To find similar documents by classification:

07.100.10 (Medical microbiology Laboratory medicine, see 11.100)

11.040.25 (Syringes, needles and catheters)

11.100 (Laboratory medicine)

11.100.01 (Laboratory medicine in general)

11.100.10 (In vitro diagnostic test systems)

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Designation Name

SS-EN ISO 6717:2021

Revision Level

2021 EDITION

Status

Current

Publication Date

Sept. 13, 2021

Language(s)

English

Page Count

24

International Equivalent

EN ISO 6717:2021(IDT); ISO 6717:2021(IDT)