ISO 11608-1:2022/FDAmd 1
(Amendment)Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1
Systèmes d'injection à aiguille pour usage médical — Exigences et méthodes d'essai — Partie 1: Systèmes d'injection à aiguille — Amendement 1
General Information
- Status
- Not Published
- Technical Committee
- ISO/TC 84 - Devices for administration of medicinal products and catheters
- Current Stage
- 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
- Start Date
- 26-Jan-2026
- Completion Date
- 26-Jan-2026
Relations
- Effective Date
- 12-Oct-2024
Overview
ISO 11608-1:2022/FDAmd 1 is an essential international standard outlining the requirements and test methods for needle-based injection systems (NIS) used in medical applications. This amendment updates Part 1 of the original ISO 11608-1:2022, specifying detailed criteria to ensure the safety, reliability, and functional stability of these medical devices. It focuses on verifying the primary functions of needle-based injection systems under both normal and stressed conditions, supporting manufacturers, regulators, and healthcare professionals in maintaining high standards of patient care and device performance.
Key Topics
- Primary Function Identification: Updated procedures emphasize assessing design specifications to determine the critical primary functions of a NIS, with a focus on dose delivery and dose accuracy.
- Test System Accuracy: The amendment mandates gauges and test apparatus to have repeatability and reproducibility (Gauge R&R) within specific limits-no greater than 20% of the specification range for non-destructive tests and 30% for destructive tests.
- Atmosphere and Environmental Conditions: Detailed protocols ensure needle-based injection systems undergo testing in controlled ambient conditions with acclimatization periods, accurately simulating real-world usage environments.
- Functional Stability Testing: Life-cycle testing is reinforced to verify device performance over 1.5 times the expected lifetime actuations, ensuring effectiveness throughout shelf life and in-use life.
- Risk and Harm Assessment: Clarifications differentiate between risk (probability and severity of harm) and unacceptable harm (severity only), guiding the identification of essential performance and primary functions.
- Stressed/Challenge Conditions: The amendment expands verification testing to include exposure to environmental stresses and transport simulations, ensuring NIS maintain their primary functions throughout their operational lifespan.
Applications
This ISO amendment is crucial for all stakeholders involved in the design, manufacture, testing, and regulation of needle-based injection systems used in medical treatments such as insulin delivery, vaccinations, or other subcutaneous and intramuscular injections. Its practical applications include:
- Medical Device Manufacturers: Ensuring design complies with rigorous functional and safety standards, facilitating regulatory approvals.
- Regulatory Agencies: Providing clear frameworks for evaluating the safety, durability, and performance of injection systems.
- Quality Assurance Teams: Implementing standardized testing to validate dose accuracy and device reliability under various conditions.
- Healthcare Providers: Trusting that injection systems meet stringent requirements for patient safety and effectiveness, enhancing clinical outcomes.
- Supply Chain and Logistics: Simulating transport and handling conditions to assess impact on device functionality, optimizing packaging and shipment.
Related Standards
ISO 11608-1:2022/FDAmd 1 works in coordination with the broader ISO 11608 series, which collectively covers different parts of needle-based injection systems including their design, performance, and safety testing. It also aligns with harmonized regulations from agencies such as the FDA, promoting international consistency. Related standards include:
- ISO 11608-2: Requirements for needle safety systems and their testing
- ISO 11608-3: Requirements focused on dose accuracy and related mechanical tests
- ISO 13485: Quality management systems for medical devices
- IEC 60601 series: Standards addressing electrical safety of medical equipment, applicable where injection systems include electromechanical components
By adhering to these standards, manufacturers can ensure their needle-based injection systems deliver precise, safe, and reliable medication administration in accordance with global best practices.
By integrating these updated requirements and rigorous testing protocols, ISO 11608-1:2022/FDAmd 1 supports innovation and safety in needle-based injection technologies, ultimately protecting patients and enhancing healthcare delivery worldwide.
ISO 11608-1:2022/FDAmd 1 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1 Released:12. 01. 2026
REDLINE ISO 11608-1:2022/FDAmd 1 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1 Released:12. 01. 2026
ISO 11608-1:2022/FDAmd 1 - Systèmes d'injection à aiguille pour usage médical — Exigences et méthodes d'essai — Partie 1: Systèmes d'injection à aiguille — Amendement 1 Released:28. 01. 2026
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Frequently Asked Questions
ISO 11608-1:2022/FDAmd 1 is a draft published by the International Organization for Standardization (ISO). Its full title is "Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1". This standard covers: Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1
ISO 11608-1:2022/FDAmd 1 is classified under the following ICS (International Classification for Standards) categories: 11.040.25 - Syringes, needles an catheters. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 11608-1:2022/FDAmd 1 has the following relationships with other standards: It is inter standard links to ISO 11608-1:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 11608-1:2022/FDAmd 1 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
FINAL DRAFT
Amendment
ISO 11608-1:2022/
FDAM 1
ISO/TC 84
Needle-based injection systems for
Secretariat: DS
medical use — Requirements and
Voting begins on:
test methods —
2026-01-26
Part 1:
Voting terminates on:
2026-03-23
Needle-based injection systems
AMENDMENT 1
Systèmes d'injection à aiguille pour usage médical — Exigences
et méthodes d'essai —
Partie 1: Systèmes d'injection à aiguille
AMENDEMENT 1
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
ISO 11608-1:2022/FDAM 1:2026(en) © ISO 2026
FINAL DRAFT
ISO 11608-1:2022/FDAM 1:2026(en)
Amendment
ISO 11608-1:2022/
FDAM 1
ISO/TC 84
Needle-based injection systems for
Secretariat: DS
medical use — Requirements and
Voting begins on:
test methods —
Part 1:
Voting terminates on:
Needle-based injection systems
AMENDMENT 1
Systèmes d'injection à aiguille pour usage médical — Exigences
et méthodes d'essai —
Partie 1: Systèmes d'injection à aiguille
AMENDEMENT 1
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 2026
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
ISO 11608-1:2022/FDAM 1:2026(en) © ISO 2026
ii
ISO 11608-1:2022/FDAM 1:2026(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 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).
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).
A list of all parts in the ISO 11608 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.
iii
ISO 11608-1:2022/FDAM 1:2026(en)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 1:
Needle-based injection systems
AMENDMENT 1
5.7.2
Replace the first paragraph with the following:
Primary functions shall be identified through an assessment of each design specification (see Figure H.2
for an example assessment process). At minimum, primary functions shall include the dose delivery
function, as specified by the dose accuracy requirements.
6.1
Replace the first paragraph and the NOTE with the following:
Any suitable test system can be used for the measurement of primary functions of the NIS, when the
required accuracy (calibration) and precision (Gauge R&R) can be obtained. The repeatability and repro-
ducibility (Gauge R&R) of the test apparatus shall be no greater than 20 % of the specification range for
any given measurement. For one-sided specifications, the other endpoint shall be established to create a
specification ra
...
ISO 11608-1:2022/DAMFDAmd 1:2025(en)
ISO/TC 84/WG 3 N 723
Replaces N 722
Secretariat: DS
Date: 2025-12-152026-01-09
Needle-based injection systems for medical use — Requirements and
test methods —
Part 1:
Needle-based injection systems
AMENDMENT 1
Systèmes d'injection à aiguille pour usage médical — Exigences et méthodes d'essai — —
Partie 1: Systèmes d'injection à aiguille
AMENDEMENT 1
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ISO #####-#:####(X)
FDIS stage
© ISO #### – All rights reserved
ISO 11608-1:2022/DAMFDAmd 1:2025(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
iii
ISO #####-#:####(X 11608-1:2022/FDAmd 1(en)
Contents
© ISO #### 2026 – All rights reserved
iv
ISO 11608-1:2022/DAMFDAmd 1:2025(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 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).
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'sISO’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).
A list of all parts in the ISO 11608 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.
v
ISO 11608-1:2022/DAM 1:2025(en)
Needle-based injection systems for medical use — Requirements and
test methods — —
Part 1:
Needle-based injection systems
AMENDMENT 1
5.7.2 Primary functions requirements
Replace the first paragraph with the following:
Primary functions shall be identified through an assessment of each design specification (see Figure H.2
for an example assessment process). At minimum, primary functions shall include the dose delivery
function, as specified by the dose accuracy requirements.
6.1 General
Replace the first paragraph and the NOTE with the following:
Any suitable test system can be used for the measurement of primary functions of the NIS, when the
required accuracy (calibration) and precision (Gauge R&R) can be obtained. The repeatability and
reproducibility (Gauge R&R) of the test apparatus shall be no greater than 20 % of the specification range
for any given measurement. For one-sided specifications, the other endpoint shall be established to create
a specification range for the assessment of the apparatus (i.e. not as a specification limit). For destructive
test measurements, the Gauge R&R shall be no greater than 30 % of the specification range. At a
minimum, the Gauge R&R should cover ±2 standard deviations (thereby covering approximately 95 % of
the variation).
NOTE An extra endpoint for one-sided specifications can be based on physical limitations of the NIS or the
measurement system (e.g. noting that a duration of time cannot be negative), or be based on the distribution of
the measurement results (e.g. setting the end-point six times the standard deviation from the mean).
NOTE An extra endpoint for one-sided specifications can be based on physical limitations of
the NIS or the measurement system (e.g. noting that a duration of time cannot be negative), or it can be
based on the distribution of the measurement results (e.g. setting the end-point six times the standard
deviation from the mean).
7.2.2 Dosing regions
Replace NOTE 1 with:
NOTE 1 If the sum of the doses set is greater than or equal to half the deliverable volume of the
container, the container can be divided i
...
PROJET FINAL
Amendement
ISO 11608-1:2022/
FDAM 1
ISO/TC 84
Systèmes d'injection à aiguille
Secrétariat: DS
pour usage médical — Exigences et
Début de vote:
méthodes d'essai —
2026-01-26
Partie 1:
Vote clos le:
2026-03-23
Systèmes d'injection à aiguille
AMENDEMENT 1
Needle-based injection systems for medical use — Requirements
and test methods —
Part 1: Needle-based injection systems
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
ISO 11608-1:2022/FDAM 1:2026(fr) © ISO 2026
PROJET FINAL
ISO 11608-1:2022/FDAM 1:2026(fr)
Amendement
ISO 11608-1:2022/
FDAM 1
ISO/TC 84
Systèmes d'injection à aiguille
Secrétariat: DS
pour usage médical — Exigences et
Début de vote:
méthodes d'essai —
2026-01-26
Partie 1:
Vote clos le:
2026-03-23
Systèmes d'injection à aiguille
AMENDEMENT 1
Needle-based injection systems for medical use — Requirements
and test methods —
Part 1: Needle-based injection systems
AMENDMENT 1
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2026 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse Numéro de référence
ISO 11608-1:2022/FDAM 1:2026(fr) © ISO 2026
ii
ISO 11608-1:2022/FDAM 1:2026(fr)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général
confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité
de tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l’ISO n’avait
pas reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa mise en application.
Toutefois, il y a lieu d’avertir les responsables de la mise en application du présent document que des
informations plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à
l’adresse www.iso.org/brevets. L’ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou
partie de tels droits de brevet.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion de
l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir le lien suivant: www.iso.org/iso/fr/avant-propos.html.
Le présent document a été élaboré par le comité technique ISO/TC 84, Dispositifs pour administration des
produits médicaux et cathéters, en collaboration avec le comité technique CEN/TC 205, Dispositifs médicaux
non actifs, du Comité européen de normalisation (CEN), conformément à l'Accord de coopération technique
entre l'ISO et le CEN (Accord de Vienne).
Une liste de toutes les parties de la série ISO 11608 peut être consultée sur le site de l’ISO.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l’adresse www.iso.org/fr/members.html.
iii
ISO 11608-1:2022/FDAM 1:2026(fr)
Systèmes d'injection à aiguille pour usage médical —
Exigences et méthodes d'essai —
Partie 1:
Systèmes d'injection à aiguille
AMENDEMENT 1
5.7.2
Remplacer le premier alinéa par ce qui suit:
Les fonctions principales doivent être identifiées au moyen d'une évaluation de chaque spécification
de conception (voir Figure H.2 pour un exemple de processus d'évaluation). Au minimum, les fonctions
principales doivent inclure la fonction d'administration de la dose, comme spécifié par les exigences
relatives à la précision de dosage.
6.1
Remplacer le premier alinéa et la NOTE par ce qui suit:
Tout système d'essai adapté peut être utilisé pour le mesurage des fonctions principales du NIS, à condition
que la précision (étalonnage) et la fidélité (garantie R&R) requises puissent être obtenues. La répétabilité
et la reproductibilité (garantie R&R) de l'appareillage d'essai ne doivent pas être supérieures à 20 % de
la plage de spécifications pour un mesurage donné. Pour les spécifications unilatérales, l'autre point final
doit être établi pour créer une plage de spécifications
...
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