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)

Overview

EN ISO 21171:2006 - Medical gloves - Determination of removable surface powder (ISO 21171:2006) specifies laboratory test methods to quantify readily removable, water‑insoluble powder on the surface of medical gloves. The standard defines three procedures: Method A for powdered gloves and Methods B and C for powder‑free gloves. The test is a physicochemical method (wash, filtration, drying, weighing) and does not set safety limits or address clinical safety implications. Applicability to non‑rubber medical gloves has not been established.

Key Topics

• Principle: Surfaces of gloves are washed with distilled/deionized water; the water‑insoluble powder is collected by suction filtration, dried and weighed to determine removable powder mass.
• Sampling: Random selection from a lot. Typical sample sizes:
  • Powdered gloves: 2 gloves
  • Powder‑free gloves: 5 gloves (surgeon’s gloves: 6)
• Apparatus & reagents:
  • Balance accurate to 0.1 mg
  • Mechanical shaker (≥ 1.7 Hz)
  • Drying oven (100 °C ± 5 °C)
  • Glass microfiber filters (90 mm and 47 mm, 2.7 µm pore size)
  • Distilled or deionized water
• Procedures:
  • Method A: multiple rinses of each glove (four fresh water rinses per glove), filtration on 90 mm filter; calculation of average mg powder per glove.
  • Methods B/C: similar approach for powder‑free gloves using 47 mm filter, pooled rinses, and blank runs because amounts are small.
• Calculation & Precision: The standard gives formulas to convert mass differences to mg of powder per glove and includes precision information and requirements for test reporting.
• Limitations: The standard is a test method only - it does not prescribe acceptable powder limits or safety criteria.

Applications

• Quality control for manufacturers of medical gloves to quantify removable surface powder during production and batch release.
• Incoming inspection by healthcare procurement and sterile supply units to verify supplier claims (powdered vs. powder‑free).
• Regulatory & conformity evidence when documenting product characteristics; the EN version includes relationship notes to EU medical device directives (informative).
• Laboratory and R&D use for comparative studies, process optimization, and material evaluation.

Who uses this standard

• Glove manufacturers and process engineers
• Independent testing laboratories and QC analysts
• Hospital sterile services and procurement officers
• Regulatory affairs specialists preparing technical files

Related Standards

• ISO 21171:2006 is based on ASTM D6124‑01 (Standard Test Method for Residual Powder on Medical Gloves).
• The EN version includes informative references to EU Directive 93/42/EEC (medical devices) for conformity context.

Keywords: EN ISO 21171:2006, medical gloves, removable surface powder, powdered gloves, powder‑free gloves, test method, filtration, weighing, quality control, regulatory compliance.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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.
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, 7, 8, 9, 10, 11 ISO 21171 is a test method and does not contain requirements for medical
gloves. Hence it cannot of itself support any essential requirement of
Directive 93/42/EEC but, in conjunction with a device specification, it
addresses ER 1, 2, 7.1, 7.2 and 7.3.
WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this International standard.

INTERNATIONAL ISO
STANDARD 21171
First edition
2006-05-01
Medical gloves — Determination
of removable surface powder
Gants à usage médical — Détermination de la poudre de surface
amovible
Reference number
ISO 21171:2006(E)
©
ISO 2006
ISO 21171:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 21171:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Principle. 1
3 Terms and definitions. 1
4 Apparatus. 2
5 Reagents. 2
6 Sampling. 2
7 Method A — Procedure for powdered gloves. 2
8 Calculation of the result (method A). 3
9 Methods B and C — Procedure for “powder-free” gloves . 3
10 Precision. 6
11 Test report. 8
Bibliography . 9

ISO 21171:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 21171 was prepared by Technical Committee ISO/TC 45, Rubber and rubber products, Subcommittee
SC 3, Raw materials (including latex) for use in the rubber industry.
This International Standard is based on ASTM D 6124-01, Standard Test Method for Residual Powder on
Medical Gloves, copyright ASTM, used with permission of ASTM.
For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council
Directives has been removed.
iv © ISO 2006 – All rights reserved

ISO 21171:2006(E)
Introduction
Depending on their method of manufacture, some medical gloves can have on their surface a small amount of
powder, normally modified corn-starch, which is intended to assist donning. Current thinking is that the
presence of excessive amounts of such powder can present a health hazard. The methods for the
determination of removable surface powder in this International Standard are based on those given in
ASTM D 6124-01, from which they differ in the method for determining removable powder from powder-free
surgeon's gloves and in the precision data.

INTERNATIONAL STANDARD ISO 21171:2006(E)

Medical gloves — Determination of removable surface powder
WARNING — Persons using this International Standard should be familiar with normal laboratory
practice. This standard does not purport to address all of the safety problems, if any, associated with
its use. It is the responsibility of the user to establish appropriate safety and health practices and to
ensure compliance with any national regulatory conditions.
1 Scope
This International Standard 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.
2 Principle
The surfaces of a glove are washed with water to remove the water-insoluble powder which is then
determined by filtration followed by weighing. The number of gloves used for the procedure depends on
whether the gloves are nominally powder-free or powdered.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
powder
all water-insoluble material on the surface of a glove that is removed by washing under the conditions of the
test
3.2
powdered gloves
gloves for which a powder has been used as a part of the manufacturing process, generally to facilitate
donning, and described by the manufacturer as “powdered”
3.3
powder-free gloves
gloves which are described by the manufacturer as “powder-free”
NOTE Gloves should always be clearly labelled as to whether they are powdered or powder-free (unlabelled gloves
would normally be unacceptable to consumers). Nevertheless, if a sample of gloves does not carry the designation
“powdered” or “powder-free”, the gloves should be analysed as if they were powdered.
ISO 21171:2006(E)
4 Apparatus
Normal laboratory glassware and tweezers, together with the following:
4.1 Balance, accurate to 0,1 mg.
4.2 Mechanical shaker, capable of a minimum oscillation frequency of 1,7 Hz (102 cycles/min).
4.3 Drying oven, capable of maintaining 100 °C ± 5 °C.
4.4 Filters, 90 mm and 47 mm glass microfibre filters of 2,7 µm pore size, together with suction filtration
apparatus.
4.5 Desiccator.
5 Reagents
5.1 Wherever water is called for, distilled or deionized water shall be used.
6 Sampling
Randomly select an appropriate number of gloves from each lot to be evaluated. For determinations on
powdered gloves, use two gloves and for determinations on powder-free gloves use five gloves except in the
case of surgeon's gloves for which use three pairs (i.e. six gloves).
7 Method A — Procedure for powdered gloves
7.1 Before use, rinse all glassware and tweezers with water.
7.2 The test shall be carried out at 25 °C ± 5 °C on two gloves randomly selected.
7.3 Take a 90 mm, 2,7 µm pore size filter and place it in the desiccator for not less than 30 min. Remove
the filter and immediately weigh it on the balance, determining the mass to the nearest 0,1 mg. Record the
mass in grams (m ).
NOTE The use of a PTFE (polytetrafluoroethylene) base is suggested if experience shows that there is a risk of
tearing the filter on removal from a glass surface.
7.4 Place the filter in the suction apparatus.
7.5 Carefully remove a glove from its packaging and insert it into a 1 l capacity conical flask, or other
suitable container, containing 500 cm of water so that 1 cm to 3 cm of the cuff projects out round the rim of
the flask. Pour approximately 250 cm of water into the glove while holding a small portion of the cuff away
from the rim of the flask to allow air to be vented from the flask. While pouring the water into the glove ensure
that the projecting part of the cuff is rinsed. Tightly seal the flask with a rubber stopper covered by a small
piece of polypropylene sheet so that the flask does not leak. Place the sealed flask in the mechanical shaker
and oscillate for 30 s at a speed of not less than 1,7 Hz. Ensure that all the surfaces of the glove are well
washed.
7.6 Take the flask
...