• There are no items in your cart

I.S. EN ISO 6710:2017

Current
Current

The latest, up-to-date edition.

SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Preview

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.

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 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

View more information
US$36.18
Excluding Tax where applicable

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.