EN ISO 6710:2017
Current
The latest, up-to-date edition.
Single-use containers for human venous blood specimen collection (ISO 6710:2017)
09-06-2017
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Draw volume
6 Design
7 Construction
8 Sterility and special microbiological states
9 Additives
10 Marking and labelling
11 Container identification
Annex A (normative) - Draw volume test for
non-evacuated containers
Annex B (normative) - Draw volume test for
evacuated containers
Annex C (normative) - Test for leakage of container
Annex D (normative) - Test for robustness of the container
Annex E (normative) - Concentrations of additives
and volume of liquid additives
Annex F (informative) - Recommended colour
codes for identifying additives and accessories
Bibliography
Annex ZA (informative) - Relationship between this
European standard and the essential
requirements of Directive 98/79/EC
[OJ L 331] aimed to be covered
ISO 6710:2017 specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers.It does not specify requirements for blood collection needles, needle holders, blood culture receptacles or "arterial" blood gas collection devices that can be used for venous blood.
| Committee |
CEN/TC 140
|
| DevelopmentNote |
Supersedes EN 14820. (09/2017)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| ISO 6710:2017 | Identical |
| UNE-EN ISO 6710:2018 | Identical |
| PN EN ISO 6710 : 2018 | Identical |
| SS-EN ISO 6710:2017 | Identical |
| BS EN ISO 6710:2017 | Identical |
| NEN EN ISO 6710 : 2017 | Identical |
| ONORM EN ISO 6710 : 2018 | Identical |
| UNI EN ISO 6710 : 2018 | Identical |
| DIN EN ISO 6710:2017-12 | Identical |
| SN EN ISO 6710 : 2018 | Identical |
| I.S. EN ISO 6710:2017 | Identical |
| NS EN ISO 6710 : 2017 | Identical |
| NF EN ISO 6710 : 2017 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN 556-2:2015 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| EN 14820:2004 | Single-use containers for human venous blood specimen collection |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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