01/564180 DC : DRAFT OCT 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS EN 14254 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
06-07-2004
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Superseded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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.