Preview

NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2012

Publisher

National Standards Authority of Ireland

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.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Sampling
6 Pre-conditioning of needles
7 Standard atmosphere and apparatus for tests
8 Determination of dislocation of measuring point at
   patient end
9 Bond between hub and needle tube
10 Packaging
11 Test method for validating the compatibility of needles
   and injector systems
12 Information supplied by the manufacturer
Annex A (normative) - Determination of flow rate through
        needle
Bibliography

Describes requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.

DocumentType	Standard
Pages	31
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 11608-2:2001

Standards	Relationship
EN ISO 11608-2:2012	Identical
UNE-EN ISO 11608-2:2012	Identical
NBN EN ISO 11608-2 : 2012	Identical
DIN EN ISO 11608-2:2012-12	Identical
UNI EN ISO 11608-2 : 2012	Identical
SN EN ISO 11608-2 : 2012	Identical
NEN EN ISO 11608-2 : 2012	Identical
NF EN ISO 11608-2 : 2012	Identical
ISO 11608-2:2012	Identical
BS EN ISO 11608-2:2012	Identical
NS EN ISO 11608-2 : 2012	Identical
ONORM EN ISO 11608-2 : 2012	Identical
DIN EN ISO 11608-2 E : 2012	Identical

ISO 15510:2014	Stainless steels Chemical composition
ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO/IEC Guide 98-1:2009	Uncertainty of measurement — Part 1: Introduction to the expression of uncertainty in measurement
ISO 11608-1:2014	Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
ISO 11608-3:2012	Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
EN 10088-1:2014	Stainless steels - Part 1: List of stainless steels
IEC 60068-2-30:2005	Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)

View more information

£54.00

Excluding VAT

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

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.

Learn more on subscription solutions

Get in touch with us

Log into your Account

I.S. EN ISO 11608-2:2012

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription