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

Publisher

National Standards Authority of Ireland

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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	I.S. EN 14820:2004

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

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I.S. EN ISO 6710:2017

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

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

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