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CEN
EN ISO 6710:2017

EN ISO 6710:2017

Current

Current

The latest, up-to-date edition.

Single-use containers for human venous blood specimen collection (ISO 6710:2017)

Published date

06-09-2017

Publisher

Comite Europeen de Normalisation

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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

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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