I.S. EN 14254:2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
Hardcopy , PDF
27-09-2021
English
01-01-2004
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
Provides requirements and test methods for single-use evacuated and non-evacuated receptacles.
DocumentType |
Standard
|
Pages |
20
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Superseded
|
SupersededBy |
Standards | Relationship |
EN 14254:2004 | Identical |
NF EN 14254 : 2004 | Identical |
BS 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 14254:2004-09 | 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 |
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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