I.S. EN ISO 6710:2017
Current
The latest, up-to-date edition.
SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017)
Hardcopy , PDF
English
01-01-2017
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.
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National Foreword
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
Defines requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers.
| DevelopmentNote |
Supersedes I.S. EN 14820. (10/2017)
|
| DocumentType |
Standard
|
| Pages |
34
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 6710:2017 | Identical |
| 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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