ISO 23907-2:2019

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 23907-2:2019(E)
©
ISO 2019

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ISO 23907-2:2019(E)

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© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
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ISO 23907-2:2019(E)

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
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ISO 23907-2:2019(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 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.
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ISO 23907-2:2019(E)

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.
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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)
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ISO 23907-2:2019(E)

3.4
decontamination
use of physical, chemical or thermal means to remove, soiling, and inactivate or destroy pathogens
where to the point they are no longer capable of transmitting infectious disease and the container is
rendered safe for handling and use
Note 1 to entry: Refer to 4.5.
3.5
fill line
mark, indicator or feature on the container that represents the fill volume (3.6)
3.6
fill volume
usable volume determined by the manufacturer and indicated by the fill line (3.5) on the container
3.7
handle
appendage, protrusion, flange or recess intended for lifting the container
3.8
integrally attached
tethered or joined to the container by a permanent means
3.9
leak-resistance
ability of a container to prevent escape of fluid
Note 1 to entry: Refer to 6.4.2.2.
3.10
lifespan
maximum number of uses and/or processing cycles as validated by the manufacturer
3.11
manufacturer's allowable gross mass
maximum mass of the container and contents as recommended by the manufacturer for safe handling
and operation
Note 1 to entry: Mass shall be measured in kilograms (kg).
3.12
needle disconnection feature
feature allowing single-handed sharps (3.21) disconnection
3.13
penetration
movement of a needle through the test specimen (3.25) until the point of the needle exits on the side
opposite the point of entry
3.14
penetration force
amount of force applied to a hypodermic needle to achieve penetration (3.13)
Note 1 to entry: The penetration force is expressed in newtons.
3.15
permanent closure
closure feature (3.3), integrally attached (3.8) to the container, which once activated cannot be re-
opened manually
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ISO 23907-2:2019(E)

3.16
pocket collectors
sharps container that has a fill volume (3.6) equal to or less than 0,6 l
Note 1 to entry: The primary design considerations for pocket collectors are to prevent penetration of the
sharp(s) through the container while providing a compact size that can be carried on the person, such as in the
user’s pocket. In order to achieve portability and a low profile, these devices have been excluded from certain
aspects of the requirements of this document.
3.17
representative sharps
representative quantities of unused 1 ml to 60 ml syringes-needles in the ratio of 70 % safety devices
with safety mechanism activated and 30 % syringe-needles with no safety device
3.18
processing
validated methods used to render a reusable sharps container, which has been previously used, safe for
handling and a subsequent use
3.19
reusable sharps container
container designed or intended by the manufacturer to be suitable for use, emptying, processing (3.18)
and subsequent reuse
3.20
secondary stabilizer
attachment or design feature intended to provide extra stability and prevent the device from
toppling over
3.21
sharps
objects capable of cutting or penetrating skin
EXAMPLE Needles of various types, syringes, scalpels, broken glass, culture slides, culture dishes, broken
capillary tubes, broken rigid plastic, exposed ends of dental wires.
3.22
sharps containment area
surface that directly encloses sharps (3.21) for the purposes of container puncture protection while in
use and in the final closed configuration
3.23
lifespan simulation
conditioning of the reusable container by repeated exposure to cycles of representative transport and
decontamination (3.4) process conditions to represent the lifespan (3.10) of the container, as specified
by the manufacturer
3.24
temporary closure
closure feature (3.3) integrally attached (3.8) to the container which, once activated for closure, can be
re-opened, without being damaged
3.25
test specimen
portion of the container obtained
Note 1 to entry: Refer to 6.3.2.1.
3.26
total volume of the container
entire air space in the closed container
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ISO 23907-2:2019(E)

4 Requirements and recommendations
4.1 General
The principles of risk assessment, as well as human factors to avoid any inappropriate use such as
incorrect assembly and overfilling, shall be considered in the design process of sharps containers.
NOTE ISO 14971 is relevant where containers are classified as a medical device.
The base dominant colour should be yellow unless local regulations state otherwise.
Fill level visibility shall be a design requirement for the containers.
When evaluated in accordance with Clause 6, the container shall show no rupture, leakage, or
deterioration that could adversely affect its safe use or functionality.
4.2 Design and construction
4.2.1 General
The materials used in the construction of reusable sharps containers shall be designed and
manufactured in a manner that enables full function, safety, and preservation of aesthetics for the
expected lifespan of the product.
4.2.2 Container stability
The container shall not topple over when tested in accordance with 6.1.
The requirement applies to containers intended for use on a horizontal surface. Sharps containers
intended to be used with a secondary stabilizer shall be tested in conjunction with the secondary
stabilizer.
Sharps containers equipped with a needle disconnection feature shall have a means whereby the
disconnection procedure is achieved with one hand.
Pocket collectors are not required to have needle disconnection feature.
4.2.3 Strength of handles
All sharps containers shall be provided with one or several handles. Where handle(s) is/are included in
the design, it shall meet the requirements of 4.2.3.
Pocket collectors are not required to have handle(s).
When tested in accordance with 6.2, the handle/carrying feature shall not break or detach during
testing. The position of the handle(s), finger recesses, protrusions or flanges shall not interfere with the
normal use of the container.
Finger recesses, if present, shall be sited above the fill line.
4.2.4 Aperture and closure
4.2.4.1 General
Reusable sharps containers shall be provided with closure features that are integrally attached. The
aperture shall be designed to minimize the potential for accidental sharps injuries during placement
of sharps into the container. There shall be an indicator or mechanism (preferably visual) to clearly
differentiate the permanent and temporary closure engagements.
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ISO 23907-2:2019(E)

Requirements regarding the attachment of the closure device do not apply to pocket collectors intended
for a single device
4.2.4.2 Requirements and recommendations for the aperture
It shall be possible to place sharps into the sharps container without using a second hand to manipulate
the aperture. The aperture of containers intended to be placed in public access areas should be designed
to restrict hand entry and removal of contents from the container.
The aperture should be designed to prevent the risk of overfilling.
4.2.4.3 Requirements and recommendations for the closure feature
Closure features shall be capable of being closed without the risk of sharps injury to the user.
The permanent closure, once activated, shall be resistant to manual opening. All containers, including
pocket collectors, shall be equipped with a temporary closure and a permanent closure.
The temporary closure, once activated for closure, shall be capable of being re-opened with one hand
without risk and without the need to grasp the body of the container.
Re-opening the temporary closure may require the use of a secondary stabilizer to reduce risk.
4.2.5 Resistance to penetration
When tested in accordance with 6.3, the force needed to penetrate test specimens shall be a minimum
of 20 N or greater.
4.2.6 Resistance to damage or leakage after dropping
When tested in accordance with 6.4, there shall be no evidence of leakage and no breach of the sharps
containment area.
Minimum five minutes after every drop, the following points shall be visually checked:
— there shall be no damage compromising safe use;
— the container’s permanent closure shall remain intact;
— handles, if present, shall remain functional.
4.2.7 Resistance to damage or leakage after toppling
When tested in accordance with 6.5, there shall be no evidence of breach of the sharps containment area.
Minimum five minutes after every topple, the following points shall be visually checked:
— there shall be no evidence that the performance or function of the container has been compromised;
— the container’s temporary closure shall remain intact.
4.2.8 Fill line
The fill line shall be determined by the design of the container, taking into account the risk of sharps
extending above the fill line, and shall be at a level no greater than 85 % of the total volume of the
container.
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ISO 23907-2:2019(E)

It shall be possible to ensure that the sharps are not above the fill line. This can be achieved either
visually or mechanically.
NOTE The container fill line feature helps prevent overfilling and is a critical safety feature of a sharps
container.
4.3 Closure device
Reusable sharps containers that have been permanently closed (e.g. locked) shall be openable only
through the use of a non-manual mechanism.
4.4 Monitoring of reuses
Each reusable container shall have a product identifier as a means of monitoring the number of reuses,
e.g. a batch number, bar code or UPC serial number.
No reusable container shall be released into the market once it has reached its lifespan, unless it is
retested according to this document.
4.5 Cleaning and decontamination
4.5.1 Cleaning and decontamination process
The cleaning and decontamination process shall be as follows:
a) designed to render the containers clean, i.e. aesthetic and visually free of soil, debris and organic
matter, and decontaminated to a level that renders them safe for handling and reuse;
NOTE Effective decontamination can commonly be achieved with the use of physical, chemical or
thermal means either singularly or in combination.
b) automated with, no manual opening, emptying, or cleaning of containers until the decontamination
process is completed;
c) capable of processing all types and sizes of each model of reusable container supplied by the
manufacturer;
d) microbiologically validated prior to commissioning, by a competent third party to confirm no
4
organisms are recovered from areas where a 10 /ml challenge-suspension of representative
pathogens in whole blood has been applied and dried. See example protocol in Annex A;
e) parametrically and continuously monitored to confirm that each container has been subjected to
the decontamination parameters stipulated by the validation process;
f) designed such that the operator is alerted (e.g. alarm, machine stop, etc.) if the process does not
meet the parameters validated prior to commissioning of the machine (see 4.5.2);
g) designed to protect operators and handlers against injury from sharps and exposure to
hazardous wastes;
h) accompanied by a post-wash quality assurance program to ensure each container:
1) is fully functional as per the manufacturer’s original specifications,
2) is aesthetically acceptable, i.e. visually clean and free from overt scuffs and scratches and
offensive odours, and
3) has intact and legible labels including the label/mechanism for determining the number of
container uses.
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ISO 23907-2:2019(E)

4.5.2 Microbiological validation
Microbiological validation of the decontamination process and establishment of the decontamination
parameters prior to commissioning of the machine is considered desirable by users of reusable sharps
containers.
The validation shall
a) establish the parameters required to achieve the decontamination level stipulated in 4.5.1, d),
b) suspend the representative pathogens in soil (e.g. blood) to simulate worst-case scenarios,
c) air-dry the applied suspension for 30 min to decrease ease of removal,
d) confirm that, after 30 min, the air-dried suspension has a viable organism count equal to that a
4
freshly applied 10 /ml challenge-suspension,
e) use sampling sites within containers that are commonly soiled, and/or most difficult to clean, and
f) be repeated if any operating parameter are changed (e.g. machine design, chemicals/time/
temperature).
NOTE See Annex A for an example protocol for suspension preparation and microbiological validation.
5 Lifespan simulation prior to testing
5.1 General
Lifespan simulation shall be conducted on a sufficient number of reusable sharps containers to meet
the requirements of Clause 6.
NOTE Lifespan simulation, i.e. tumbling (see 5.3), transport (see 5.4), and processing (see 5.5), is designed
to simulate the stresses of lifespan usage on closures and container surfaces and materials and, following
completion, these same containers are subjected to the tests in Clause 6.
5.2 Conditioning
Prior to lifespan simulations specified in 5.3 and 5.4, reusable sharps containers shall be conditioned at
an ambient room temperature of (23 ± 2) °C for a minimum of 2 h.
If processing simulations are interrupted for more than 4 h, conditioning at (23 ± 2) °C for a minimum
of 2 h shall occur prior to commencing the next simulation session.
5.3 Tumbling with sharps simulation
The lifespan tumbling simulation shall be conducted as follows.
a) Fill the containers to their fill capacity with representative sharps.
b) Activate the permanent closure of the sharps container.
c) Affix the containers in a suitable apparatus and rotate the containers over their longest axis at a
revolution rate of 60 r/min for 5 min for containers intended for up to 100 uses by the manufacturer
and for 5 additional minutes for every 100 (or part thereof) additional reuses intended by the
manufacturer.
d) Proceed to transport simulations in 5.4.
The sharps used in 5.3 and 5.4 pose an injury risk to handlers and shall be handled and disposed of
accordingly.
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ISO 23907-2:2019(E)

5.4 Transport simulations
The lifespan transport simulations shall be conducted as follows.
a) Use the filled containers from 5.3.
b) Place the containers on a vibrating platform that has a vertical or rotary double-amplitude (peak-
to-peak displacement) of 25,4 mm (1,0 inch). Constrain the containers horizontally to prevent them
from falling off the platform, but leave them free to move vertically, bounce, and rotate.
c) The vibration shall be performed at a frequency that causes the containers to be raised from the
vibrating platform to such a degree that a piece of material of approximately 1,6 mm (0,063 inch)
thickness (such as steel strapping or paperboard) can be passed between the bottom of any package
and the platform.
d) Vibrate the containers for 1 h for containers intended for up to 100 uses by the manufa
...