ISO 11193-1:2002

Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution

ISO 11193-1 specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves with smooth surfaces or with textured surfaces over part or all of the glove. This standard is intended as a reference for the performance and safety of rubber examination gloves. The safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures are outside the scope of this standard.

Gants en caoutchouc pour examen, non réutilisables — Partie 1: Spécifications pour gants fabriqués à partir de latex de caoutchouc ou d'une solution de caoutchouc

General Information

• Status: Withdrawn
• Publication Date: 24-Oct-2002
• Withdrawal Date: 24-Oct-2002
• ICS: 11.140 - Hospital equipment
• ICS: 83.140.99 - Other rubber and plastics products
• Technical Committee: ISO/TC 45/SC 4 - Products (other than hoses)
• Drafting Committee: ISO/TC 45/SC 4/WG 5 - Gloves and other latex products
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 26-Aug-2008

Relations

• Parent: ISO 11193-1:2002/Amd 1:2007 - Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution — Amendment 1
• Effective Date: 15-Apr-2008
• Revised: ISO 11193-1:2008 - Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution
• Effective Date: 15-Apr-2008
• Revises: ISO 11193:1994 - Single-use rubber examination gloves — Specification
• Effective Date: 15-Apr-2008
• Amended By: ISO 11193-1:2002/Amd 1:2007 - Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution — Amendment 1
• Effective Date: 06-Jun-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 11193-1
First edition
2002-11-01
Single-use medical examination gloves —
Part 1:
Specification for gloves made from rubber
latex or rubber solution
Gants en caoutchouc pour examen, non réutilisables —
Partie 1: Spécifications pour gants fabriqués à partir de latex de caoutchouc
ou d'une solution de caoutchouc

Reference number
ISO 11193-1:2002(E)
© ISO 2002

---------------------- Page: 1 ----------------------
ISO 11193-1:2002(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be
edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file,
parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters
were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event
that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2002
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's
member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.ch
Printed in Switzerland
©
ii ISO 2002 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 11193-1:2002(E)
Contents Page
1 Scope . 1
2 Normative references . 1
3 Classification . 1
4 Materials . 2
5 Sampling and selection of test pieces . 2
6 Requirements . 3
7 Packaging . 6
8 Marking . 6
Annex
A Test for watertightness . 8
©
ISO 2002 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 11193-1:2002(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 3.
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 part of ISO 11193 may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 11193-1 was prepared by Technical Committee ISO/TC 45, Rubber and rubber products,
Subcommittee SC 4, Products (other than hoses).
This part of ISO 11193 cancels and replaces ISO 11193:1994, which has been technically revised.
ISO 11193 consists of the following parts, under the general title Single-use medical examination gloves:
— Part 1: Specification for gloves made from rubber latex or rubber solution
— Part 2: Specification for gloves made from poly(vinyl chloride)
Annex A forms a normative part of this part of ISO 11193.
©
iv ISO 2002 – All rights reserved

---------------------- Page: 4 ----------------------
INTERNATIONAL STANDARD ISO 11193-1:2002(E)
Single-use medical examination gloves —
Part 1:
Specification for gloves made from rubber latex or rubber solution
1 Scope
This part of ISO 11193 specifies requirements for packaged sterile, or bulked non-sterile, rubber gloves intended for
use in medical examinations and diagnostic or therapeutic procedures to protect the patient and the user from cross-
contamination. It also covers rubber gloves intended for use in handling contaminated medical materials and gloves
with smooth surfaces or with textured surfaces over part or all of the glove.
This part of ISO 11193 is intended as a reference for the performance and safety of rubber examination gloves. The
safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and
storage procedures are outside the scope of this part of ISO 11193.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 11193. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 11193 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated references,
the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of
currently valid International Standards.
ISO 37:1994, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 188:1998, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2859-1:1999, Sampling procedures for inspection by attributes — Part1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 4648:1991, Rubber, vulcanized or thermoplastic — Determination of dimensions of test pieces and products for
test purposes
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
3 Classification
3.1 General
Gloves are classified by type and finish, as given in 3.2 and 3.3.
©
ISO 2002 – All rights reserved 1

---------------------- Page: 5 ----------------------
ISO 11193-1:2002(E)
3.2 Type
Two types are classified:
a) Type 1: gloves made primarily from natural rubber latex;
b) Type 2: gloves made primarily from nitrile rubber latex, polychloroprene rubber latex, styrene-butadiene rubber
solution, styrene-butadiene rubber emulsion or thermoplastic elastomer solution.
3.3 Finish
Four finishes are classified:
a) textured surface over part or all of the gloves;
b) smooth surface;
c) powdered surface;
d) powder-free surface.
NOTE 1 Powdered gloves are gloves where a powder has been applied on the gloves as a part of the manufacturing process,
generally to facilitate donning. Powder-free gloves are gloves which have been manufactured without the deliberate application of
powdered materials. Powder-free is also referred to as “powderless”, “no powder” or “non-powdered”, or other words to that effect.
NOTE 2 The cuff termination of the glove may be cut or in the form of a rolled rim.
4Materials
Gloves shall be manufactured from compounded natural rubber or nitrile rubber or polychloroprene rubber latex, or
compounded styrene-butadiene rubber or thermoplastic elastomer solution, or compounded styrene-butadiene
rubber emulsion. To facilitate donning the gloves, any surface treatment, lubricant, powder or polymer coating may be
used subject to compliance with ISO 10993.
Any pigment used shall be non-toxic. It is essential that substances used for surface treatment which are capable of
being transferred are bio-absorbable.
Gloves as supplied to the user shall comply with the relevant part(s) of ISO 10993. The manufacturer shall make
available to the purchaser, on request, data to support compliance with these requirements.
NOTE 1 Other suitable polymeric materials may be included in future parts of ISO 11193.
NOTE 2 It is recognized that some individuals may, over a period of time, become sensitized to a particular rubber compound
(allergic reaction) and require gloves of an alternative formulation.
NOTE 3 Limits of extractable proteins, allergenic proteins, residual chemicals, endotoxins and residual powder in gloves may b
...