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BS EN 14254:2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Hardcopy , PDF

Superseded date

08-09-2021

Language(s)

English

Published date

07-07-2004

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Nominal liquid capacity
6 Graduation and fill lines
   6.1 Graduation lines
   6.2 Minimum fill line
   6.3 Maximum fill line
7 Design
8 Construction
9 Sterility and special microbiological states
10 Additives
11 Information supplied by the manufacturer
Annex A (normative) Tests for nominal capacity, graduation
                    lines and minimum free space for
                    non-evacuated specimen receptacles up
                    to and including 30 ml nominal capacity
   A.1 Reagents and apparatus
   A.2 Test Conditions
   A.3 Test procedure
Annex B (normative) Tests for nominal capacity, graduation
                    lines and minimum free space, for
                    non-evacuated specimen receptacles of
                    greater than 30 ml nominal capacity
   B.1 Reagents and apparatus
   B.2 Test conditions
   B.3 Test procedures
Annex C (normative) Tests for draw volume and minimum free
                    space for evacuated receptacles
   C.1 Reagents and apparatus
   C.2 Test conditions
   C.3 Test procedure
Annex D (normative) Test for leakage from the closure of
                    a receptacle
   D.1 Reagents and apparatus
   D.2 Test procedure for non-evacuated receptacles intended
       for storage above 0 degree C
   D.3 Test procedure for non-evacuated receptacles intended
       for storage at 0 degree C or below
   D.4 Test procedure for evacuated receptacles
Annex E (normative) Test for the robustness of a receptacle
                    that is intended for centrifugation
   E.1 Reagents and apparatus
   E.2 Test conditions
   E.3 Test procedure
Annex ZA (informative) Relationship between this European
                       Standard and the Essential
                       Requirements of EU Directive 98/79/EC
Bibliography

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.

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

Committee
CH/212
DevelopmentNote
Supersedes 01/564180 DC. (07/2004)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 14254:2004 Identical
I.S. EN 14254:2004 Identical
NF EN 14254 : 2004 Identical
NS EN 14254 : 1ED 2004 Identical
UNI EN 14254 : 2004 Identical
SN EN 14254 : 2004 Identical
NEN EN 14254 : 2004 Identical
NBN EN 14254 : 2004 Identical
UNE-EN 14254:2004 Identical
ONORM EN 14254 : 2004 Identical
DIN EN 14254 E : 2004 Identical
DIN EN 14254:2004-09 Identical

EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 4788:2005 Laboratory glassware Graduated measuring cylinders
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
EN 829 : 1996 IN VITRO DIAGNOSTIC SYSTEMS - TRANSPORT PACKAGES FOR MEDICAL AND BIOLOGICAL SPECIMENS - REQUIREMENTS, TESTS
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 980:2008 Symbols for use in the labelling of medical devices
EN 14820:2004 Single-use containers for human venous blood specimen collection
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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