ISO 10282:2014
(Main)Single-use sterile rubber surgical gloves — Specification
Single-use sterile rubber surgical gloves — Specification
ISO 10282:2014 specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded. It does not apply to examination or procedure gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole glove. ISO 10282:2014 is intended as a reference for the performance and safety of rubber surgical gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent handling, packaging, and storage procedures are outside the scope of ISO 10282:2014.
Gants en caoutchouc à usage chirurgical, stériles, non réutilisables — Spécifications
General Information
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 10282
Third edition
2014-02-01
Single-use sterile rubber surgical
gloves — Specification
Gants en caoutchouc à usage chirurgical, stériles, non réutilisables —
Spécifications
Reference number
ISO 10282:2014(E)
©
ISO 2014
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ISO 10282:2014(E)
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ii © ISO 2014 – All rights reserved
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ISO 10282:2014(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Classification . 1
3.1 General . 1
3.2 Type . 1
3.3 Design . 2
3.4 Finish . 2
4 Materials . 2
5 Sampling and selection of test pieces . 2
5.1 Sampling . 2
5.2 Selection of test pieces . 3
6 Requirements . 3
6.1 Dimensions . 3
6.2 Watertightness . 6
6.3 Tensile properties . 6
6.4 Sterility . 7
7 Packaging . 7
8 Marking . 7
8.1 General . 7
8.2 Inner package . 8
8.3 Unit package . 8
8.4 Multi-unit package . 8
Annex A (normative) Test for watertightness . 9
© ISO 2014 – All rights reserved iii
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ISO 10282:2014(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 45, Rubber and rubber products, Subcommittee
SC 4, Products (other than hoses).
This third edition cancels and replaces the second edition (ISO 10282:2002), of which it constitutes
a minor revision. It also incorporates the Technical Corrigendum ISO 10282:2002/Cor.1:2005 and the
following changes:
— addition of isoprene rubber latex as material for type 2 glove;
— only two finishes remain for classification, whereby powdered or powder-free finishes were deleted
and introduced in the note;
— addition on the applicability of the warning note to the unit package on the removal of surface-
dusting material prior to undertaking operative procedures.
iv © ISO 2014 – All rights reserved
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INTERNATIONAL STANDARD ISO 10282:2014(E)
Single-use sterile rubber surgical gloves — Specification
1 Scope
This International Standard specifies requirements for packaged sterile rubber gloves intended for use
in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to
single-use gloves that are worn once and then discarded. It does not apply to examination or procedure
gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole
glove.
This International Standard is intended as a reference for the performance and safety of rubber surgical
gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent
handling, packaging, and storage procedures are outside the scope of this International Standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 37, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied
ISO 23529, Rubber — General procedures for preparing and conditioning test pieces for physical test methods
3 Classification
3.1 General
Gloves are classified by type, design, and finish, as given in 3.2 to 3.4.
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, isoprene rubber latex, polychloroprene
rubber latex, styrene-butadiene rubber solution, styrene-butadiene rubber emulsion or
thermoplastic elastomer solution.
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ISO 10282:2014(E)
3.3 Design
Two designs are classified:
a) gloves with straight fingers;
b) gloves with fingers curved in the palmar direction.
The glove shall be anatomically correct, with the thumb positioned towards the palmar surface of
the index finger rather than lying flat. The fingers and thumb can be straight or curved in the palmar
direction.
3.4 Finish
Two finishes are classified:
a) textured surface over part or all of the glove;
b) smooth surface.
NOTE 1 Gloves can be powdered or powder-free. Powdered gloves
...
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