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NS EN 14254 : 1ED 2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

09-18-2021

Published date

01-12-2013

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.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Superseded
SupersededBy

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

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