ISO/FDIS 23908
(Main)Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration — Requirements and test methods
Sharps injury protection — Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration — Requirements and test methods
This document provides clear methods for performance-testing for sharps-injury protection mechanisms, whether active or passive in design, for medical devices containing single-used ‘sharps’ for administration and/or extraction of body/blood fluids and/or medicinal substances. Testing will confirm usability and elimination of exposure to, and risk of accidental injury from, contaminated ‘sharps’ during the period of intended use, including the paths to final disposal.
Protection contre les blessures par perforants — Mécanismes de protection des aiguilles à usage unique, des introducteurs pour cathéters et des aiguilles utilisées pour les prélèvements, le contrôle et l’échantillonnage sanguins et l’administration de substances médicales — Exigences et méthodes d’essai
General Information
Relations
Buy Standard
Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/TC 84
Sharps injury protection — Sharps
Secretariat: DS
protection mechanisms for
Voting begins on:
single-use needles, introducers
2024-09-13
for catheters and needles used
Voting terminates on:
for blood testing, monitoring,
2024-11-08
sampling and medical substance
administration — Requirements
and test methods
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING 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.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 84
Sharps injury protection — Sharps
Secretariat: DS
protection mechanisms for
Voting begins on:
single-use needles, introducers
2024-09-13
for catheters and needles used
for blood testing, monitoring, Voting terminates on:
sampling and medical substance
2024-11-08
administration — Requirements
and test methods
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.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ii
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms. 3
5 Requirements . 4
5.1 General .4
5.2 Activation of the sharps injury protection mechanism .5
5.2.1 Active SIPM . .5
5.2.2 Passive SIPM .5
5.3 Security of safe mode protection .5
6 Test methods . 6
6.1 General .6
6.2 Test procedure and results analysis methodology .6
6.3 Testing activation of a sharps injury protection mechanism .7
6.3.1 Principle .7
6.3.2 Apparatus .7
6.3.3 Procedure .7
6.4 Challenging the SIPM in safe mode .7
6.4.1 General .7
6.4.2 Overriding or unlocking test .8
6.4.3 Resistance of the SIPM in safe mode to free fall .8
6.5 Testing access to the sharp in safe mode .9
7 Information supplied with the device . 9
7.1 General .9
7.2 Marking/labelling .10
7.3 Instructions for use .10
Annex A (normative) Methods for testing access to the sharp in safe mode .11
Annex B (informative) Example of apparatus for performing the free fall test .13
Annex ZA (informative) Relationship between this European Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 14
Bibliography . 17
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 23908:2011), which has been technically
revised.
The main changes are as follows:
— the Scope has been expanded to cover single-use needles, introducers for catheters and needles used for
blood testing, monitoring, sampling and medical substance administration;
— reference has been made to medical devices standards ISO 14971, IEC 62366-1, ISO 11608-1, ISO 20417;
— a falling test has been added, with as a pass/fail the non-access to the sharps, in order to cover a frequent
misuse situation and avoid a potential increase of the risk of sharp injury;
— updates on the test methods Gauge R&R requirements for destructive testing (threshold becoming no
greater than 30 % of the specification interval for destructive test, instead of 20 % for any other given
measurement);
— a new requirement for A-SIPM, to include misuse situations (obvious or non-obvious) in the risk assess-
ment and to mitigate them as far as possible by product design has been introduced;
— a new requirement to apply a force of min. 5 N for challenging the access to the sharp has been added;
— normative Annex A has been revised to include the methods for testing the access to the sharp in safe
mode and after free fall;
iv
— recovery of the device and the SIPM has been added, only as a possibility, and can be included in the
device life cycle.
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.
v
Introduction
This document addresses sharps injury protection mechanism designed to protect users and others who can
incidentally be exposed to such devices post-use. These sharps injury protection mechanisms are intended
to prevent, or reduce the potential risk for, disease transmission which can result from accidental, post-use
sharps injuries.
This document addresses devices primarily intended for human use, of a wide range of product types,
including but not limited to hollow-bore needles for injection or infusion of therapeutics into the body, or
sampling of fluids from the body, and hollow-bore or solid-core needles used for blood sampling (e.g. lancing
devices).
Given the broad variation in product design, categories of device, and sharps protection technologies,
and in order to avoid unnecessarily restricting innovation, this document has been developed to provide
general design, testing and labelling requirements, rather than specific physical and prescriptive design
requirements. It therefore differs from documents which list specific maximum forces, detailed test fixture
designs, test systems to be used or detailed test measures, as such prescriptive details cannot cover the
variety of designs and devices. Including such details can impede continuing innovation in new products,
mechanisms a
...
2024-05-27
ISO/DISFDIS 23908:2023(E)
ISO/TC 84/WG 8
Secretariat: DS
Date: 2024-09-10
Sharps injury protection — Sharps protection mechanisms for single-
use needles, introducers for catheters and needles used for blood
testing, monitoring, sampling and medical substance administration
— Requirements and test methods
FDIS stage
ISO/DISFDIS 23908:2023(E2024(en)
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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/DISFDIS 23908:2023(E2024(en)
Contents
Foreword . iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviated terms . 3
5 Requirements . 4
5.1 General . 4
5.2 Activation of the sharps injury protection mechanism . 5
5.3 Security of safe mode protection . 5
6 Test methods . 6
6.1 General . 6
6.2 Test procedure and results analysis methodology . 6
6.3 Testing activation of a sharps injury protection mechanism . 7
6.4 Challenging the SIPM in safe mode . 8
6.5 Testing access to the sharp in safe mode . 10
7 Information supplied with the device . 10
7.1 General . 10
7.2 Marking/labelling . 10
7.3 Instructions for use . 10
Annex A (normative) Methods for testing access to the sharp in safe mode . 12
Annex B (informative) Example of apparatus for performing the free fall test . 15
Annex ZA (informative) Relationship between this European Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 17
Bibliography . 22
iii
ISO/DISFDIS 23908:2023(E2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 23908:2011), which has been technically
revised.
This second/third/… edition cancels and replaces the first/second/… edition (ISO #####:####), which has
been technically revised.
The main changes are as follows:
— — The Scope has been expanded to cover single-use needles, introducers for catheters and needles used
for blood testing, monitoring, sampling and medical substance administration;
— — Reference to the following medical devices standards: ISO 14971, IEC 62366-1, ISO 11608-1, ISO
20417;
— — A falling test has been added, with as a pass/fail the non-access to the sharps, in order to cover a
frequent misuse situation and avoid a potential increase of the risk of sharp injury;
— — Updates on the test methods Gauge R&R requirements for destructive testing (threshold becoming no
greater than 30 % of the specification interval for destructive test, instead of 20% for any other given
measurement);
iv
ISO/DISFDIS 23908:2023(E2024(en)
— — A new requirement for A-SIPM, to include misuse situations (obvious or non-obvious) in the risk
assessment and to mitigate them as far as possible by product design has been introduced.
— A new requirement to apply a force of min. 5N for challenging the access to the sharp has been added
— A totally revised normative Annex A to include the methods for testing the access to the sharp in safe
mode and after free fall.
— Recovery of the device and the SIPM has been added, only as a possibility, and can be included in the
device life cycle.
— The standards ISO 23907-1 (Single-use sharps containers, revised in 2019), and ISO 23907-2
(Reusable sharps containers, created in 2019), had significantly improved the prevention of health risks and
the safety for all the persons that manipulate post-use sharps medical devices.
— However, taking into account the need to intensify the security of sharps medical devices post-use as
well as the growing need to reduce their environmental impact by encouraging the possibility allowing their
recycling, this revision constitutes an additional tool for the user’s health protection and the preservation of
the environment.
— the Scope has been expanded to cover single-use needles, introducers for catheters and needles used
for blood testing, monitoring, sampling and medical substance administration;
— reference has been made to medical devices standards ISO 14971, IEC 62366-1, ISO 11608-1,
ISO 20417;
— a falling test has been added, with as a pass/fail the non-access to the sharps, in order to cover a
frequent misuse situation and avoid a potential increase of the risk of sharp injury;
— updates on the test methods Gauge R&R requirements for destructive testing (threshold becoming no
greater than 30 % of the specification interval for destructive test, instead of 20 % for any other given
measurement);
— a new requirement for A-SIPM, to include misuse situations (obvious or non-obvious) in the risk
assessment and to mitigate them as far as possible by product design has been introduced;
— a new requirement to apply a force of min. 5 N for challenging the access to the sharp has been added;
— normative Annex A has been revised to include the methods for testing the access to the sharp in safe
mode and after free fall;
— recovery of the device and the SIPM has been added, only as a possibility, and can be included in the
device life cycle.
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.
v
ISO/DISFDIS 23908:2023(E2024(en)
Introduction
This document addresses sharps injury protection mechanism designed to protect users and others who
maycan incidentally be exposed to such devices post-use. These sharps injury protection mechanisms are
intended to prevent, or reduce the potential risk for, disease transmission which can result from accidental,
post-use sharps injuries.
This document addresses devices primarily intended for human use, of a wide range of product types,
including but not limited to hollow-bore needles for injection or infusion of therapeutics into the body, or
sampling of fluids from the body, and hollow-bore or solid-core needles used for blood sampling (e.g. lancing
devices).
Given the broad variation in product design, categories of device, and sharps protection technologies, and in
order to avoid unnecessarily restricting innovation, this document has been developed to provide general
design, testing and labelling requirements, rather than specific physical and prescriptive design requirements.
It therefore differs from documents which list specific maximum forces, detailed test fixture designs, test
systems to be used or detailed test measures, as such prescriptive details cannot cover the variety of designs
and devices. Including such details maycan impede continuing innovation in new products, mechanisms
and/or protection mechanisms that lead to future improvements in healthcare.
This document presumes that the product developer uses a risk-based approach (consistent with
ISO 14971:2019) to determine the device design that best meets the needs of a target user population and
expected use settings. Through this risk-based approach, the sharps injury protection mechanism would have
performance requirements appropriate to the foreseeable risks associated with the intended use of the device,
expected user interfaces and the settings in which these sharps injury protection mechanismmechanisms are
expected to be used.
This document provides guidelines to enable the manufacturer to verify that the design of the sharps injury
protection mechanism complies with the design intent spelled out in the design specification.
As part of this validation, the manufacturer is expected to demonstrate that the performance of the sharps
injury protection mechanism is appropriate to the intended users and settings through the use of appropriate
formative or summative user interface evaluations. These studies allow the manufacturer to demonstrate that,
when used in accordance with the instructions for use, in settings representative of real-life intended use and
by intended or foreseeable users, the mechanism functions as intended.
The standards ISO 23907-1 (covering single-use sharps containers, revised in 2019), and ISO 23907-2
(covering reusable sharps containers, created in 2019), have significantly improved the prevention of health
risks and the safety for all the persons that manipulate post-use sharps medical devices.
However, taking into account the need to intensify the security of sharps medical devices post-use as well as
the growing need to reduce their environmental impact by encouraging the possibility of allowing their
recycling, this revision constitutes an additional tool for the user’s health protection and the preservation of
the environment.
vi
Sharps injury protection — Requirements and test methods
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.