SIST EN ISO 11608-5:2023
(Main)Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2022)
Dieses Dokument legt Anforderungen an und Prüfverfahren für automatisierte Funktionen in kanülenbasierten Injektionssystemen mit automatisierten Funktionen (NIS AUTOs) fest.
Für alle automatisierten Funktionen werden allgemeine Anforderungen bereitgestellt. Darüber hinaus werden spezifische allgemeine Anforderungen für die folgenden automatisierten Funktionen bereitgestellt:
a) Arzneimittelzubereitung (z. B. Rekonstitution);
b) Vorbereitung der Kanüle;
c) Kanülenverdeckung;
d) Betriebsbereitmachen;
e) Einstellen der Dosis;
f) Einführen der Kanüle;
g) Steuerung der Injektionstiefe;
h) Injizieren des Arzneimittels;
i) Aufzeichnung der Gerätefunktionen;
ANMERKUNG Dieses Dokument behandelt keine Fernkommunikationsfunktionen von NIS AUTOs (bezieht sich auf die drahtgebundene und drahtlose Kommunikationsübertragung von dem NIS AUTO).
j) Deaktivieren des NIS AUTO;
k) Einziehen der Kanüle;
l) Abschirmung der Kanüle;
m) Entfernen der Kanüle.
Alle Verweisungen auf „Funktion“ in diesem Dokument werden laut Definition als automatisierte Funktion ausgelegt (siehe 3.2). Dieses Dokument ist nicht anwendbar für Funktionen, die vom Benutzer manuell ausgeführt werden.
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai - Partie 5: Fonctions automatisées (ISO 11608-5:2022)
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del: Avtomatizirane funkcije (ISO 11608-5:2022)
Ta del standarda ISO 11608 določa zahteve in preskusne metode za avtomatizirane funkcije peres za injiciranje (navedene v standardu kot NIS-AUTO), ki so namenjene dajanju zdravil ljudem. Ta dokument ne obravnava oddaljene komunikacije iz NIS-AUTO.
General Information
Relations
Overview
EN ISO 11608-5:2023 - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022) defines safety, performance and test-method expectations for needle-based injection systems that include automated functions (referred to as NIS‑AUTO). Adopted by CEN in 2023, this part of the ISO 11608 series complements ISO 11608-1 and focuses on the automated behaviours of medical injection devices (it does not cover remote communication capabilities).
Key topics and technical requirements
The standard addresses automated functional areas and associated test methods, including:
- General requirements for NIS‑AUTO design and safety verification.
- Medicinal product preparation and needle preparation procedures to ensure correct administration.
- Priming and dose setting: requirements to verify correct priming and accurate dose selection.
- Needle extension, insertion and retraction, including injection depth control when depth is determined automatically by the device.
- Dose delivery and dose accuracy testing (test methods specified to confirm delivered dose matches intended dose).
- Needle hiding and shielding before and after injection to reduce needlestick risk.
- Recording of device functions and disabling the NIS‑AUTO (safety and user awareness requirements).
- Detailed test methods and test conditions for verifying actuation, injection time, retracted position, shielding performance and more.
- Informative annexes with rationale and example test methods (e.g., dose accuracy at intended injection depth).
The document emphasizes verifying outputs of automated designs rather than prescribing exact mechanisms, supporting innovation in device design while ensuring patient safety.
Practical applications and users
EN ISO 11608-5:2023 is essential for:
- Medical device manufacturers developing autoinjectors, automated injection platforms or delivery modules with automated functions.
- Regulatory and conformity assessment bodies assessing device compliance for market approval and CE marking across CEN member states.
- Design, verification and validation engineers who implement and test automated needle functions (dose accuracy, depth control, shielding).
- Quality assurance and test laboratories executing the specified test methods.
- Procurement and clinical technology managers evaluating device safety features for hospitals and home-care settings.
Use the standard when designing, validating or specifying NIS‑AUTO to demonstrate compliance with accepted international safety and performance criteria.
Related standards
- ISO 11608-1 (general requirements and terminologies for needle-based injection systems)
- Other parts of the ISO 11608 series (device-specific requirements and test methods)
Keywords: EN ISO 11608-5:2023, ISO 11608-5:2022, needle-based injection systems, automated functions, NIS‑AUTO, dose accuracy, injection depth control, needle shielding, medical device standards.
Frequently Asked Questions
SIST EN ISO 11608-5:2023 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)". This standard covers: This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.
SIST EN ISO 11608-5:2023 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.
SIST EN ISO 11608-5:2023 has the following relationships with other standards: It is inter standard links to SIST EN ISO 11608-5:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN ISO 11608-5:2023 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2023
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 5. del:
Avtomatizirane funkcije (ISO 11608-5:2022)
Needle-based injection systems for medical use - Requirements and test methods - Part
5: Automated functions (ISO 11608-5:2022)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 5: Automatisierte Funktionen (ISO 11608-5:2022)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 5: Fonctions automatisées (ISO 11608-5:2022)
Ta slovenski standard je istoveten z: EN ISO 11608-5:2023
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11608-5
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2023
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 11608-5:2012
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 5: Automated
functions (ISO 11608-5:2022)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 5: Fonctions Verwendung - Anforderungen und Prüfverfahren - Teil
automatisées (ISO 11608-5:2022) 5: Automatisierte Funktionen (ISO 11608-5:2022)
This European Standard was approved by CEN on 10 March 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-5:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 11608-5:2022 has been prepared by Technical Committee ISO/TC 84 "Devices for
administration of medicinal products and catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 11608-5:2023 by Technical Committee
CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2023, and conflicting national standards
shall be withdrawn at the latest by September 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11608-5:2012.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11608-5:2022 has been approved by CEN as EN ISO 11608-5:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 11608-5
Second edition
2022-04
Needle-based injection systems for
medical use — Requirements and test
methods —
Part 5:
Automated functions
Systèmes d'injection à aiguille pour usage médical — Exigences et
méthodes d'essai —
Partie 5: Fonctions automatisées
Reference number
ISO 11608-5:2022(E)
ISO 11608-5:2022(E)
© ISO 2022
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 11608-5:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 4
4.1 General requirements . 4
4.2 Medicinal product preparation . 5
4.3 Needle preparation . 6
4.4 Needle hiding . 6
4.5 Priming . 6
4.6 Dose setting . 6
4.7 Needle insertion . 6
4.8 Injection depth control . 6
4.9 Dose delivery . 7
4.10 Recording of device functions . 7
4.11 Needle retraction . 7
4.11.1 Completion of dose delivery . 7
4.11.2 Needle retraction distance . 7
4.11.3 Communication of completion . 7
4.12 Disabling the NIS-AUTO. 7
4.13 Needle shielding . 8
4.13.1 General . 8
4.13.2 Needle shielding before injection . 8
4.13.3 Needle shielding after injection . 8
4.14 Needle removal from the NIS-AUTO . 8
5 Test methods . 8
5.1 General . 8
5.2 Test conditions . 9
5.3 Actuation . 9
5.4 Medicinal product preparation . 9
5.5 Needle inspection . 9
5.6 Needle hiding . 9
5.7 Priming . 10
5.8 Needle extension . 10
5.9 Injection time . 10
5.10 Dose accuracy . 11
5.11 Retracted position . 11
5.12 Disabling the NIS-AUTO. 11
5.13 Needle shielding . 11
5.13.1 Needle shielding before and after injection . 11
5.13.2 Needle shielding after free fall. 11
6 Information supplied with the NIS-AUTO .11
Annex A (informative) Rationale for requirements .12
Annex B (informative) Example of a test method for dose accuracy at intended injection
depth .14
Annex C (informative) Needle extension and intended injection depth .16
Bibliography .22
iii
ISO 11608-5:2022(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.
This second edition cancels and replaces the first edition (ISO 11608-5:2012), which has been
technically revised.
The main changes are as follows:
— this document has been clarified to explain that an automated function is one which does not require
user interaction after the action which initiates the function, including designating injection depth
control as automated when the user does not have control over the depth to which the needle is
inserted, even where needle insertion is performed manually.
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.
iv
ISO 11608-5:2022(E)
Introduction
This document is applicable to needle-based injection systems (NIS) with automated functions (NIS-
AUTO) primarily intended to administer medicinal products to humans. In order to support device
innovation and design, this document has been written in a format that describes the output of the
design effort rather than prescribing the exact form of construction of the NIS-AUTO This document
should be used in conjunction with ISO 11608-1.
v
INTERNATIONAL STANDARD ISO 11608-5:2022(E)
Needle-based injection systems for medical use —
Requirements and test methods —
Part 5:
Automated functions
1 Scope
This document specifies requirements and test methods for automated functions in needle-based
injection systems with automated functions (NIS-AUTO).
General requirements are provided for all automated functions. In addition, specific requirements are
provided for the following automated functions:
a) medicinal product preparation (e.g. reconstitution);
b) needle preparation;
c) needle hiding;
d) priming;
e) dose setting;
f) needle insertion;
g) injection depth control;
h) injection of the medicinal product;
i) recording of device functions;
NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and
wireless communication transfer from the NIS auto).
j) disabling the NIS-AUTO;
k) needle retraction;
l) needle shielding;
m) needle removal.
All references to "function" in this document are by definition construed as automated functions (see
3.2). This document does not apply to functions that are performed manually by the user.
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 11608-1:2022, Needle-based injection systems for medical use — Requirements and test methods —
Part 1: Needle-based injection systems
ISO 11608-5:2022(E)
ISO 11608-3:2022, Needle-based injection systems for medical use — Requirements and test methods —
Part 3: Containers and integrated fluid paths
ISO 23908:2011, Sharps injury protection — Requirements and test methods — Sharps protection features
for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11608-1 and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
actuation
user action that initiates an automated function
EXAMPLE Needle insertion (3.13). Pressing the needle-based injection system with automated function (3.18)
against the injection site.
3.2
automated function
function that does not require user interaction after actuation (3.1)
Note 1 to entry: Dose counting.
3.3
disabling
function that changes the state of the needle-based injection system with automated function (NIS-AUTO)
(3.18) such that it is not able to be refilled, reloaded, reset, or reactivated for dose delivery, which will
allow the NIS-AUTO to perform any subsequent injections (including single-dose and the last dose of
multi-dose NIS-AUTOs)
3.4
dose setting
function that sets the dose to be delivered
3.5
injection depth control
function or feature that controls the needle extension (3.11) such that the medicinal product is delivered
at the intended injection depth (3.8)
3.6
injection of medicinal product
function that delivers the dose
3.7
injection time
time from initiation to completion of the injection of medicinal product (3.6) as described in the
instructions for use
Note 1 to entry: The injection time that might be indicated in the instructions for use (IFU, sometime called hold
time) can be the same or greater than the measured injection time, based on use risk approach.
Note 2 to entry: There can be a delay from actuation to initiation of injection that might be indicated in the IFU
which might be measured and verified separately as determined by risk approach.
ISO 11608-5:2022(E)
3.8
intended injection depth
range of distance from the skin surface to the point at which the medicinal product is intended to be
delivered
Note 1 to entry: See Figures in Annex C.
3.9
medicinal product preparation
function that prepares the medicinal product for administration
EXAMPLE Reconstitution, filling of reservoir.
3.10
needle cover
cover provided over a needle in order to protect the needle from damage and users from unintended
needle sticks prior to use
Note 1 to entry: A needle cover alone is not a sharps injury protection feature unless it conforms to ISO 23908.
3.11
needle extension
distance from the patient end of the needle tip to the nearest part of the needle-based injection system
with automated function (3.18) body
Note 1 to entry: The nearest part of the needle-based injection system with automated function body is the point
of contact with the patient adjacent to the injection site.
Note 2 to entry: See Annex C for more details.
3.12
needle hiding
function that intentionally obscures the needle from the user's sight before, during and/or after the
injection cycle
3.13
needle insertion
function that inserts the needle into the injection site to the intended injection depth (3.8) prior to the
injection of the medicinal product (3.6)
3.14
needle preparation
function that prepares the needle for use
Note 1 to entry: Needle attachment, removal of needle cover (3.10).
3.15
needle removal
function that disconnects the needle from the needle-based injection system with automated function
(3.18) fluid path
3.16
needle retraction
function that removes the needle from the target tissue to a predefined position inside the needle-based
injection system with automated function (3.18)
ISO 11608-5:2022(E)
3.17
needle shielding
function that covers the needle before and/or after the injection cycle to reduce the likelihood of direct
contact with the needle
Note 1 to entry: Needle shielding alone is not a sharps injury protection feature unless it conforms with
ISO 23908.
3.18
needle-based injection system with automated function
NIS-AUTO
injection system that delivers a medicinal product through a needle wherein one or a series of functions
are initiated by an action of the user and controlled automatically by the injection system
Note 1 to entry: A manual needle-based injection system with accessories that perform automatic functions are
regarded as NIS-AUTO.
3.19
persistent visual indication
visual indication that remains in place until the state of the needle-based injection system changes or
until the end of the needle-based injection system use-life
3.20
recording
function that records information
EXAMPLE Dose counter.
Note 1 to entry: A needle-based injection system with automated function (3.18) might include several different,
possibly related, recording functions, which record different pieces of information related to the dose
administered.
4 Requirements
4.1 General requirements
a) Automated functions shall be verified in accordance with the design verification approach in
ISO 11608-1, including sampling plan and data analysis, applying the requirements and test
methods in this document.
b) Where the completion of an automated function is intended to be communicated to the user,
the needle-based injection system (NIS) shall indicate by visual, audible or tactile means, or any
combination of these that the function has been completed unless otherwise specified in this
document. These means should be appropriate to the intended use of the NIS.
c) Users shall be able to clearly distinguish between a NIS-AUTO that is unused, in use, used or
disabled or requiring another user action such as a "setup" step before it can be used again. For
automated functions that change the state of the NIS-AUTO, a persistent visual indication of the
NIS-AUTO state shall be provided (e.g. ready for use, in use, disabled or other states relevant for the
particular NIS-AUTO).
d) Where the design of a NIS-AUTO allows manual operations to be performed in a sequence other
than that specified in the instructions for use, the risk assessment shall address the risks of out-of-
sequence operation.
e) Actuation of each automated function shall meet the following requirements:
1) Actuation of injection: A minimum of two manual actions shall be required in order to initiate
injection, e.g. from locked to unlocked state/ready for injection, then press to actuate. A
ISO 11608-5:2022(E)
multi-dose/use injection system with automated functions, once actuated, shall not allow an
additional actuation without a separate and distinct action prior to a subsequent actuation.
2) Actuation shall be tested in accordance with 5.3.
f) Automated functions shall not compromise the primary functions of the NIS-AUTO.
g) For each automated function included within the NIS-AUTO design, testing in accordance with
Clause 5 shall be performed. If the function is not included or is not automated within the design,
the relevant requirements of Clause 4 do not apply and testing in accordance with Clause 5 shall
not be performed. Table 1 provides a matrix of the specific requirements and test methods for each
automated function.
h) Where requirements in this document provide a test method without acceptance criteria, a
specification and acceptance criteria shall be established for the automated function appropriate
to the intended use of the NIS-AUTO and using a risk-based approach.
i) Where this document does not provide requirements and/or a test method, there shall be
established a specification, acceptance criteria, and a method of verifying the automated function
appropriate to the intended use of the NIS-AUTO and using a ri
...
SIST EN ISO 11608-5:2023は、医療用の針ベースの注射システムに関する重要な基準を提供しています。この標準は、自動化された機能を備えた針ベースの注射システム（NIS-AUTO）についての要件及び試験方法を具体的に定めています。医薬品を人間に投与する際の安全性や効果性を高めるために、非常にRelevantなガイドラインを示しています。 この標準の強みは、NIS-AUTOシステムの設計と運用における一貫性を確保するための明確な枠組みを提供する点です。試験方法が詳細に記載されているため、製品の評価がシステマティックに行えるようになり、品質向上に寄与します。また、標準が医薬品の投与に関する具体的な要件をカバーしているため、医療従事者が安全に使用できるシステムの開発をサポートします。 さらに、この規格は医療機器の開発者や製造者に対して、製品の信頼性を向上させるための指針を提供するため、業界全体の成長と革新を促進するリーダーシップを示しています。標準化された要件と試験方法があることで、国際的な規制にも対応しやすくなり、グローバルマーケットでの競争力を向上させる一助となります。 SIST EN ISO 11608-5:2023は、現代の医療において不可欠な基準であり、患者の安全を第一に考えた上での技術革新をために重要な役割を果たします。
The SIST EN ISO 11608-5:2023 is a pivotal standard that delineates the requirements and test methods for needle-based injection systems with automated functions (NIS-AUTO) intended for the administration of medicinal products in humans. Its focused scope ensures that manufacturers and developers of such technologies adhere to stringent safety and efficacy criteria, enhancing patient care. One of the key strengths of this standard lies in its comprehensive outline of automated functions, addressing the intricacies of modern injection systems that are becoming increasingly prevalent in healthcare settings. By establishing clear guidelines, the standard promotes consistency and reliability in NIS-AUTO products, which is crucial for ensuring patient safety during medical procedures. Moreover, the document emphasizes the importance of rigorous testing methods, which serve to validate the operational performance and reliability of these innovative systems. This focus on testing is particularly relevant in an era where the integration of advanced technology in medical applications necessitates confidence from both healthcare providers and patients. The relevance of SIST EN ISO 11608-5:2023 cannot be understated, particularly as the demand for automated medical solutions continues to rise. As the healthcare landscape evolves, standardization in needle-based delivery systems helps facilitate regulatory compliance and fosters innovation within the industry. By adhering to the specifications detailed in this standard, stakeholders can ensure that their products not only meet quality benchmarks but also align with global best practices.
La norme SIST EN ISO 11608-5:2023 est un document essentiel pour les systèmes d'injection à aiguille destinés à un usage médical, spécifiquement ceux intégrant des fonctions automatisées, désignés dans le texte comme NIS-AUTO. Le champ d'application de cette norme est clairement défini, englobant les exigences et les méthodes d'essai applicables aux dispositifs médicaux utilisés pour l'administration de produits médicaux chez l'homme. Une des forces majeures de cette norme réside dans sa capacité à établir des exigences précises qui garantissent la sécurité et l'efficacité des systèmes d'injection automatisés. En fournissant des méthodes d'essai rigoureuses, la norme permet aux fabricants de valider les performances de leurs dispositifs, assurant ainsi le respect des standards de qualité et de sécurité pour les utilisateurs finaux. De plus, la pertinence de la norme SIST EN ISO 11608-5:2023 ne saurait être sous-estimée dans le contexte actuel de l'innovation technologique dans le domaine médical. L'augmentation de l'utilisation de systèmes automatisés pour l'administration de médicaments souligne la nécessité de régulations claires afin de protéger les patients tout en favorisant l'efficacité des traitements. En excluant la communication à distance des NIS-AUTO, la norme se concentre sur les interactions directes des dispositifs avec les utilisateurs, ce qui est primordial pour les essais cliniques et l'approbation réglementaire. En somme, la norme SIST EN ISO 11608-5:2023 représente un outil fondamental pour les fabricants et les régulateurs dans le secteur des dispositifs médicaux, confrontés aux défis de l'automatisation croissante dans l'administration des traitements.
SIST EN ISO 11608-5:2023 표준은 자동화된 기능을 갖춘 주사기 시스템(NIS-AUTO)에 대한 요구사항과 시험 방법을 명확히 규정하고 있습니다. 이 표준은 인간에게 의약품을 주입하는 데 필요한 핵심 요소들을 구체적으로 다루며, 의료 분야에서의 적용 가능성을 높이고 있습니다. 이 표준의 강점은 자동 주사 시스템의 안전성 및 효율성을 강화하기 위한 명확한 요구사항을 제시하고 있다는 점입니다. 특히, 사용 중 발생할 수 있는 다양한 위험 요소를 사전에 식별하고 평가할 수 있는 데 중요한 역할을 합니다. 이러한 요구사항은 제조업체가 제품 개발 과정에서 준수해야 하는 기준을 명확히 하여, 사용자에게 안전하고 신뢰성 있는 의료 기기를 제공하는 데 기여합니다. 또한, SIST EN ISO 11608-5:2023 표준은 NIS-AUTO의 자동화 기능을 평가하기 위한 테스트 방법을 제공함으로써, 사용자가 의도한 대로 기능이 정확히 작동하는지에 대한 객관적인 검증 매커니즘을 제공합니다. 이러한 점은 의료 제공자와 환자가 만족할 수 있는 결과를 얻는 데 필수적입니다. 이 표준은 특히 자동화된 툴들이 의료 환경에서 점차 증가하는 추세와 관련하여 더욱 중요성을 띄고 있습니다. 자동화를 통해 주사 시의 오류를 줄일 수 있으며, 이에 따라 환자의 안전성을 향상시킬 수 있습니다. 그러나, 이 문서에서는 NIS-AUTO로부터의 원거리 통신은 다루지 않기 때문에, 사용자는 이와 관련된 추가적인 안전성 및 보안 환기를 고려할 필요가 있습니다. 결론적으로, SIST EN ISO 11608-5:2023 표준은 자동 주사기 시스템 개발에 필수적인 가이드라인과 기준을 제공하며, 의료 분야에서의 자동화 기술 적용의 신뢰성과 안전성을 높이는 데 매우 중요한 역할을 합니다.
Die SIST EN ISO 11608-5:2023 ist ein bedeutender Standard, der spezifische Anforderungen und Prüfmethoden für nadelbasierte Injektionssysteme mit automatisierten Funktionen (NIS-AUTO) definiert. Diese Norm ist besonders relevant für die medizinische Anwendung bei der Verabreichung von Arzneimitteln an Menschen. Ein wesentlicher Vorteil des Standards liegt in seiner umfassenden Abdeckung der automatisierten Funktionen von Injektionssystemen. Durch die detaillierte Beschreibung dieser Funktionen wird die Entwicklung sicherer und effektiver Injektionsgeräte gefördert, die die Patientenversorgung verbessern können. Die klare Festlegung von Anforderungen und Testmethoden hilft Herstellern, Qualität und Sicherheit ihrer Produkte zu gewährleisten und die regulatorischen Vorgaben zu erfüllen. Die Norm behandelt nicht nur die technischen Spezifikationen, sondern auch sicherheitsrelevante Aspekte, wodurch sie als unverzichtbares Dokument für Entwickler und Hersteller im Bereich der medizintechnischen Geräte angesehen werden kann. Die SIST EN ISO 11608-5:2023 trägt maßgeblich zur Standardisierung in der Branche bei und stellt sicher, dass die medizinischen Injektionssysteme mit automatisierten Funktionen effizient und zuverlässig arbeiten. Die Relevanz der SIST EN ISO 11608-5:2023 erstreckt sich über die bloße Produktentwicklung hinaus. Sie fördert auch das Vertrauen der Nutzer in diese Technologien, da sie die notwendigen Sicherheitsstandards aufrecht erhält. Aufgrund des rasanten Fortschritts in der Medizintechnologie und der steigenden Nachfrage nach automatisierten Administrationssystemen bietet dieser Standard einen wichtigen Leitfaden für die Zukunft der Patientenversorgung.
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