EN ISO 21171:2006

Medical gloves - Determination of removable surface powder (ISO 21171:2006)

ISO 21171:2006 specifies methods for the determination of readily removable powder on the surface of gloves for medical use. Three methods are specified: method A for powdered gloves and methods B and C for powder-free gloves. This International Standard does not address safety issues that may be associated with the presence of powder on gloves nor does it prescribe limits on the amounts that may be present. The applicability of this International Standard to medical gloves not made from rubber has not been established.

Medizinische Handschuhe - Bestimmung des entfernbaren Oberflächenpuders (ISO 21171:2006)

Diese Internationale Norm legt Verfahren für die Bestimmung von leicht zu entfernendem Puder auf der Oberfläche von Handschuhen für den medizinischen Gebrauch fest. Es werden drei Verfahren festgelegt: Verfahren A für gepuderte Handschuhe und Verfahren B und C für puderfreie Handschuhe. In dieser Internationalen Norm werden weder Fragen der Sicherheit behandelt, die mit dem Vorhandensein von Puder auf Handschuhen zusammenhängen können, noch werden die Grenzen der Mengen vorgeschrieben, die vorhanden sein dürfen. Die Anwendbarkeit dieser Internationalen Norm für medizinische Handschuhe, die nicht aus Kautschuk hergestellt sind, ist nicht nachgewiesen.

Gants à usage médical - Détermination de la poudre de surface amovible (ISO 21171:2006)

L'ISO 21171:2006 spécifie des méthodes permettant de déterminer la quantité de poudre résiduelle qui peut facilement être enlevée, présente sur la surface des gants à usage médical. Trois méthodes sont spécifiées: la méthode A pour les gants poudrés et les méthodes B et C pour les gants sans poudre. La présente Norme internationale n'aborde pas les questions de sécurité qui peuvent être liées à la présence de poudre sur les gants, et ne spécifie pas non plus les limites de quantités qui peuvent être présentes. Il n'a pas été établi que la présente Norme internationale peut s'appliquer aux gants à usage médical qui ne sont pas en caoutchouc

Medicinske rokavice - Določanje odstranljivega površinskega pudra (ISO 21171:2006)

General Information

• Status: Published
• Publication Date: 30-Apr-2006
• Withdrawal Date: 29-Nov-2006
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 3 - Medical gloves
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-May-2006
• Completion Date: 01-May-2006
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 21171:2006 - Medical gloves - Determination of removable surface powder (ISO 21171:2006)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21171:2006
01-julij-2006
0HGLFLQVNHURNDYLFH'RORþDQMHRGVWUDQOMLYHJDSRYUãLQVNHJDSXGUD,62

Medical gloves - Determination of removable surface powder (ISO 21171:2006)
Medizinische Handschuhe - Bestimmung des entfernbaren Oberflächenpuders (ISO
21171:2006)
Gants a usage médical - Détermination de la poudre de surface amovible (ISO
21171:2006)
Ta slovenski standard je istoveten z: EN ISO 21171:2006
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN ISO 21171:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 21171
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2006
ICS 11.140

English Version
Medical gloves - Determination of removable surface powder
(ISO 21171:2006)
Gants à usage médical - Détermination de la poudre de Medizinische Handschuhe - Bestimmung des entfernbaren
surface amovible (ISO 21171:2006) Oberflächenpuders (ISO 21171:2006)
This European Standard was approved by CEN on 3 April 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21171:2006: E
worldwide for CEN national Members.

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EN ISO 21171:2006 (E)





Foreword


This document (EN ISO 21171:2006) has been prepared by Technical Committee ISO/TC 45
"Rubber and rubber products" in collaboration with Technical Committee CEN/TC 205 "Non-active
medical devices", the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2006, and conflicting national
standards shall be withdrawn at the latest by November 2006.

This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 21171:2006 has been approved by CEN as EN ISO 21171:2006 without any
modifications.

2

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EN ISO 21171:2006 (E)



ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC



This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to
essential requirements of the New Approach Directive 93/42/EEC.

Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compliance with
the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of
this standard, a presumption of conformity with the corresponding essential requirements of that
Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clauses of this European Corresponding essential requirements (ERs) of
Standard
EU Directive 93/42/EEC
4, 5, 6
...