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01/564180 DC : DRAFT OCT 2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN 14254 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
Superseded date

06-07-2004

Published date

23-11-2012

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Nominal capacity
6 Marks on the container
   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
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
Annex C (normative) Tests for draw volume and minimum free space
        for evacuated receptacles
Annex D (normative) Test for leakage from the closure of a
        receptacle
Annex E (normative) Test for the robustness of a receptacle
        that is intended for centrifugation
Annex ZA (normative) Clauses of this European Standard addressing
         essential requirements or other provisions of EU
         Directives
Bibliography

BS EN 14254

Committee
CH/29
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
PREN 14254 : DRAFT 2001 Identical

EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 4788:2005 Laboratory glassware Graduated measuring cylinders
ISO 6710:2017 Single-use containers for human venous blood specimen collection
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
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 980:2008 Symbols for use in the labelling of medical devices
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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