Single-use medical examination gloves

This document 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 all or part of the glove. This document is intended as a reference for the performance and safety of rubber examination gloves. It does not cover the safe and proper usage of examination gloves and sterilization procedures with subsequent handling, packaging and storage procedures.

Gants en caoutchouc pour examen, non réutilisables

General Information

Status
Published
Publication Date
05-Aug-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
04-Jul-2020
Completion Date
03-Jul-2020
Ref Project

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INTERNATIONAL ISO
STANDARD 11193-1
Third edition
2020-08
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 11193-1:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 11193-1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 11193-1:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Classification ............................................................................................................................................................................................................ 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Type .................................................................................................................................................................................................................. 2

4.3 Finish ............................................................................................................................................................................................................... 2

5 Materials ....................................................................................................................................................................................................................... 2

6 Sampling and selection of test pieces ............................................................................................................................................. 3

6.1 Sampling ....................................................................................................................................................................................................... 3

6.2 Selection of test pieces ..................................................................................................................................................................... 3

7 Requirements .......................................................................................................................................................................................................... 3

7.1 Dimensions ................................................................................................................................................................................................. 3

7.2 Water tightness ....................................................................................................................................................................................... 5

7.3 Tensile properties ................................................................................................................................................................................. 5

7.3.1 General...................................................................................................................................................................................... 5

7.3.2 Force at break and elongation at break before accelerated ageing ...................................... 5

7.3.3 Force at break and elongation at break after accelerated ageing .......................................... 5

7.4 Sterility .......................................................................................................................................................................................................... 5

8 Packaging ..................................................................................................................................................................................................................... 5

9 Marking .......................................................................................................................................................................................................................... 6

9.1 General ........................................................................................................................................................................................................... 6

9.2 Unit package .............................................................................................................................................................................................. 6

9.2.1 Sterile package ................................................................................................................................................................... 6

9.2.2 Non-sterile package ........................................................................................................................................... ............ 6

9.3 Multi-unit package ............................................................................................................................................................................... 7

Annex A (normative) Test method for watertightness ...................................................................................................................... 8

Bibliography .............................................................................................................................................................................................................................11

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 11193-1:2020(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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 45, Rubber and rubber products,

Subcommittee SC 4, Products (other than hoses).

This third edition cancels and replaces the second edition (ISO 11193-1:2008), which has been

technically revised. It also partially incorporates the Amendment ISO 11193-1:2008/Amd: 2012.

The main changes compared to the previous edition are as follows:
— some general and editorial changes have been made in 4.1, 4.3, and Clause 5;

— the measurement of length has been corrected from the second finger to middle finger  in 7.1,

paragraph 2;
— the NOTE has been changed to main text in 7.3.3;
— the value has been corrected in Table 3;
— some general and editorial changes have been made to Annex A;
— the limit of powdered gloves has been included;
— Figures 1 and 2 of the previous edition have been replaced with Figure 1:
— updates have been made to the powdered surface and powder-free surface;
— the statement on aging gloves over six months old has been updated.
A list of all parts in the ISO 11193 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
INTERNATIONAL STANDARD ISO 11193-1:2020(E)
Single-use medical examination gloves —
Part 1:
Specification for gloves made from rubber latex or rubber
solution

WARNING — Persons using this document should be familiar with normal laboratory practices.

This document 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 regulatory conditions.
1 Scope

This document 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 all or

part of the glove.

This document is intended as a reference for the performance and safety of rubber examination gloves.

It does not cover the safe and proper usage of examination gloves and sterilization procedures with

subsequent handling, packaging and storage procedures.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. 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 23529, Rubber — General procedures for preparing and conditioning test pieces for physical test methods

3 Terms and definitions
No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1
---------------------- Page: 5 ----------------------
ISO 11193-1:2020(E)
4 Classification
4.1 General
Gloves are classified by type and finish, as given in 4.2 and 4.3.
4.2 Type
a) Type 1: gloves made primarily from natural rubber latex.
b) Type 2: gloves mad
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 11193-1
ISO/TC 45/SC 4
Single-use medical examination
Secretariat: DSM
gloves —
Voting begins on:
2020-05-08
Part 1:
Voting terminates on:
Specification for gloves made from
2020-07-03
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
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 11193-1:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 11193-1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 11193-1:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Classification ............................................................................................................................................................................................................ 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Type .................................................................................................................................................................................................................. 2

4.3 Finish ............................................................................................................................................................................................................... 2

5 Materials ....................................................................................................................................................................................................................... 2

6 Sampling and selection of test pieces ............................................................................................................................................. 3

6.1 Sampling ....................................................................................................................................................................................................... 3

6.2 Selection of test pieces ..................................................................................................................................................................... 3

7 Requirements .......................................................................................................................................................................................................... 3

7.1 Dimensions ................................................................................................................................................................................................. 3

7.2 Water tightness ....................................................................................................................................................................................... 5

7.3 Tensile properties ................................................................................................................................................................................. 5

7.3.1 General...................................................................................................................................................................................... 5

7.3.2 Force at break and elongation at break before accelerated ageing ...................................... 5

7.3.3 Force at break and elongation at break after accelerated ageing .......................................... 5

7.4 Sterility .......................................................................................................................................................................................................... 5

8 Packaging ..................................................................................................................................................................................................................... 5

9 Marking .......................................................................................................................................................................................................................... 6

9.1 General ........................................................................................................................................................................................................... 6

9.2 Unit package .............................................................................................................................................................................................. 6

9.2.1 Sterile package ................................................................................................................................................................... 6

9.2.2 Non-sterile package ........................................................................................................................................... ............ 6

9.3 Multi-unit package ............................................................................................................................................................................... 7

Annex A (normative) Test method for watertightness ...................................................................................................................... 8

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 11193-1:2020(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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 45, Rubber and rubber products,

Subcommittee SC 4, Products (other than hoses).

This third edition cancels and replaces the second edition (ISO 11193-1:2008), which has been

technically revised. It also partially incorporates the Amendment ISO 11193-1:2008/Amd: 2012.

The main changes compared to the previous edition are as follows:
— some general and editorial changes have been made in 4.1, 4.3, and Clause 5;

— the measurement of length has been corrected from the second finger to middle finger  in 7.1,

paragraph 2;
— the NOTE has been changed to main text in 7.3.3;
— the value has been corrected in Table 3;
— some general and editorial changes have been made to Annex A;
— the limit of powdered gloves has been included;
— Figures 1 and 2 of the previous edition have been replaced with Figure 1:
— updates have been made to the powdered surface and powder-free surface;
— the statement on aging gloves over six months old has been updated.
A list of all parts in the ISO 11193 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 11193-1:2020(E)
Single-use medical examination gloves —
Part 1:
Specification for gloves made from rubber latex or rubber
solution

WARNING — Persons using this document should be familiar with normal laboratory practices.

This document 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 regulatory conditions.
1 Scope

This document 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 all or

part of the glove.

This document is intended as a reference for the performance and safety of rubber examination gloves.

It does not cover the safe and proper usage of examination gloves and sterilization procedures with

subsequent handling, packaging and storage procedures.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. 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 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied

ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information

to be supplied — Part 2: Symbol development, selection and validation

ISO 23529, Rubber — General procedures for preparing and conditioning test pieces for physical test methods

3 Terms and definit
...

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