ISO 23907-2:2019
(Main)Sharps injury protection — Requirements and test methods — Part 2: Reusable sharps containers
Sharps injury protection — Requirements and test methods — Part 2: Reusable sharps containers
This document specifies requirements for reusable sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes. This document is applicable to sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user. It is not applicable to single use sharps containers (refer to ISO 23907-1 for such containers). This document includes design functionality for user safety, lifespan simulation, cleaning and decontamination, microbiological validation, quality monitoring and performance testing.
Protection contre les blessures par perforants — Exigences et méthodes d'essai — Partie 2: Conteneurs réutilisables pour perforants
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INTERNATIONAL ISO
STANDARD 23907-2
First edition
2019-11
Sharps injury protection —
Requirements and test methods —
Part 2:
Reusable sharps containers
Protection contre les blessures par perforants — Exigences et
méthodes d'essai —
Partie 2: Conteneurs réutilisables pour perforants
Reference number
©
ISO 2019
© ISO 2019
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 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements and recommendations. 4
4.1 General . 4
4.2 Design and construction . 4
4.2.1 General. 4
4.2.2 Container stability . 4
4.2.3 Strength of handles . 4
4.2.4 Aperture and closure . 4
4.2.5 Resistance to penetration . 5
4.2.6 Resistance to damage or leakage after dropping . 5
4.2.7 Resistance to damage or leakage after toppling . 5
4.2.8 Fill line . 5
4.3 Closure device . 6
4.4 Monitoring of reuses . 6
4.5 Cleaning and decontamination . 6
4.5.1 Cleaning and decontamination process . 6
4.5.2 Microbiological validation . 7
5 Lifespan simulation prior to testing . 7
5.1 General . 7
5.2 Conditioning . 7
5.3 Tumbling with sharps simulation . 7
5.4 Transport simulations . 8
5.5 Processing simulations . 8
6 Test methods . 8
6.1 Container stability . . 8
6.2 Strength of handle(s) . 8
6.3 Resistance to penetration . 9
6.3.1 Apparatus . 9
6.3.2 Procedure . 9
6.4 Resistance to damage and leakage after dropping .10
6.4.1 Apparatus .10
6.4.2 Procedure .10
6.5 Resistance to spillage by toppling .11
6.5.1 Apparatus .11
6.5.2 Procedure .11
7 Quality monitoring: Post decontamination quality assurance .11
8 Labelling and marking and instructions for use .12
8.1 Labelling and marking .12
8.2 Instructions for use .13
Annex A (informative) Microbiological validation .14
Bibliography .17
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 84, Devices for administration of medicinal
products and catheters.
A list of all parts in the ISO 23907 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 2019 – All rights reserved
Introduction
Reusable sharps containers are designed for the containment and disposal of sharps such as scalpel
blades, trocars, hypodermic needles and syringes. They are supplied in a wide range of sizes and can
be manufactured from a variety of materials. This document does not specify the size range of the
containers or the materials selected to manufacture the containers.
Sharps containers can be either single-use or reusable. This document covers reusable sharps
containers.
INTERNATIONAL STANDARD ISO 23907-2:2019(E)
Sharps injury protection — Requirements and test
methods —
Part 2:
Reusable sharps containers
1 Scope
This document specifies requirements for reusable sharps containers intended to hold potentially
hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars,
hypodermic needles and syringes.
This document is applicable to sharps containers that are supplied complete by the manufacturer and
to those that are supplied as components intended to be assembled by the user.
It is not applicable to single use sharps containers (refer to ISO 23907-1 for such containers).
This document includes design functionality for user safety, lifespan simulation, cleaning and
decontamination, microbiological validation, quality monitoring and performance testing.
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 7864, Sterile hypodermic needles for single use — Requirements and test methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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/
3.1
aperture
opening of the sharps container through which sharps (3.21) are deposited for disposal
3.2
clean
visually free of soil, debris and organic matter
3.3
closure feature
flap, plug, lid or slide that is intended to close the aperture (3.1)
3.4
decontamination
use of physical, chemical or thermal means to remove, soiling, and inactivate or destroy pathogens
where to the poi
...
INTERNATIONAL ISO
STANDARD 23907-2
First edition
2019-11
Sharps injury protection —
Requirements and test methods —
Part 2:
Reusable sharps containers
Protection contre les blessures par perforants — Exigences et
méthodes d'essai —
Partie 2: Conteneurs réutilisables pour perforants
Reference number
©
ISO 2019
© ISO 2019
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 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements and recommendations. 4
4.1 General . 4
4.2 Design and construction . 4
4.2.1 General. 4
4.2.2 Container stability . 4
4.2.3 Strength of handles . 4
4.2.4 Aperture and closure . 4
4.2.5 Resistance to penetration . 5
4.2.6 Resistance to damage or leakage after dropping . 5
4.2.7 Resistance to damage or leakage after toppling . 5
4.2.8 Fill line . 5
4.3 Closure device . 6
4.4 Monitoring of reuses . 6
4.5 Cleaning and decontamination . 6
4.5.1 Cleaning and decontamination process . 6
4.5.2 Microbiological validation . 7
5 Lifespan simulation prior to testing . 7
5.1 General . 7
5.2 Conditioning . 7
5.3 Tumbling with sharps simulation . 7
5.4 Transport simulations . 8
5.5 Processing simulations . 8
6 Test methods . 8
6.1 Container stability . . 8
6.2 Strength of handle(s) . 8
6.3 Resistance to penetration . 9
6.3.1 Apparatus . 9
6.3.2 Procedure . 9
6.4 Resistance to damage and leakage after dropping .10
6.4.1 Apparatus .10
6.4.2 Procedure .10
6.5 Resistance to spillage by toppling .11
6.5.1 Apparatus .11
6.5.2 Procedure .11
7 Quality monitoring: Post decontamination quality assurance .11
8 Labelling and marking and instructions for use .12
8.1 Labelling and marking .12
8.2 Instructions for use .13
Annex A (informative) Microbiological validation .14
Bibliography .17
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 84, Devices for administration of medicinal
products and catheters.
A list of all parts in the ISO 23907 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 2019 – All rights reserved
Introduction
Reusable sharps containers are designed for the containment and disposal of sharps such as scalpel
blades, trocars, hypodermic needles and syringes. They are supplied in a wide range of sizes and can
be manufactured from a variety of materials. This document does not specify the size range of the
containers or the materials selected to manufacture the containers.
Sharps containers can be either single-use or reusable. This document covers reusable sharps
containers.
INTERNATIONAL STANDARD ISO 23907-2:2019(E)
Sharps injury protection — Requirements and test
methods —
Part 2:
Reusable sharps containers
1 Scope
This document specifies requirements for reusable sharps containers intended to hold potentially
hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars,
hypodermic needles and syringes.
This document is applicable to sharps containers that are supplied complete by the manufacturer and
to those that are supplied as components intended to be assembled by the user.
It is not applicable to single use sharps containers (refer to ISO 23907-1 for such containers).
This document includes design functionality for user safety, lifespan simulation, cleaning and
decontamination, microbiological validation, quality monitoring and performance testing.
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 7864, Sterile hypodermic needles for single use — Requirements and test methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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/
3.1
aperture
opening of the sharps container through which sharps (3.21) are deposited for disposal
3.2
clean
visually free of soil, debris and organic matter
3.3
closure feature
flap, plug, lid or slide that is intended to close the aperture (3.1)
3.4
decontamination
use of physical, chemical or thermal means to remove, soiling, and inactivate or destroy pathogens
where to the poi
...
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