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

Status
Published
Publication Date
23-Jan-2014
Current Stage
6060 - International Standard published
Start Date
18-Dec-2013
Completion Date
24-Jan-2014
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ISO 10282:2014 - Single-use sterile rubber surgical gloves -- Specification
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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)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
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Tel. + 41 22 749 01 11
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Published in Switzerland
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.
© ISO 2014 – All rights reserved 1
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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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