BS EN 14254:2004 - In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans – BSI British Standards

BS EN 14254:2004

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

Status : Current, Under review   Published : July 2004

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BS EN 14254:2004 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 14820.

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 European standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.




Standard NumberBS EN 14254:2004
TitleIn vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans
StatusCurrent, Under review
Publication Date06 July 2004
Confirm Date14 March 2019
Normative References(Required to achieve compliance to this standard)EN ISO 3696, ISO 3696:1987, ISO 4788
Informative References(Provided for Information)EN 829, 98/79/EC, EN 552, EN 375, EN 14820, EN 554, 67/548/EEC, UN 650, EN 550, EN 1041, EN 980, 93/42/EEC, ISO 15223, UN 602, ISO 7000
International RelationshipsEN 14254:2004
Draft Superseded By01/564180 DC
DescriptorsMedical inspection, Medical equipment, Diagnosis (medical), Disposable, Clinical laboratory equipment, Patients, Clinical investigation instruments, Medical specimens, Containers, Performance testing
ICS11.100
11.100.10
Title in FrenchDispositifs medicaux de diagnostic in vitro. Recipients a usage unique pour prelevement humains non sanguins
Title in GermanIn-vitro-Diagnostika. Einmalgefaesse fuer Untersuchungsgut vom Menschen mit Ausnahme von Blutproben
CommitteeCH/212
ISBN0 580 44020 6
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size425 KB
Price£130.00


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