SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2013

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 Test methods
6 Information supplied by the manufacturer
Annex A (informative) - Guidance on simulated user studies
Annex B (informative) - Method for testing access to the
        sharp in safe mode
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements
         of EU Directive 93/42/EEC on Medical Devices
Bibliography

Provides requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling.

DocumentType	Standard
Pages	25
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 23908:2011

Standards	Relationship
EN ISO 23908:2013	Identical
ISO 23908:2011	Identical

IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 16269-6:2014	Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

View more information

US$36.18

Excluding Tax where applicable

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 23908:2013

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription