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SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 11608-4:2008
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del:
Peresa za injiciranje z elektronskimi elementi (ISO 11608-4:2022)
Needle-based injection systems for medical use - Requirements and test methods - Part
4: Needle-based injection systems containing electronics (ISO 11608-4:2022)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile
enthalten (ISO 11608-4:2022)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d’essai -
Partie 4: Systèmes d'injection à aiguille contenant de l'électronique (ISO 11608-4:2022)
Ta slovenski standard je istoveten z: EN ISO 11608-4:2022
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 11608-4
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 11608-4:2007
English Version
Needle-based injection systems for medical use -
Requirements and test methods - Part 4: Needle-based
injection systems containing electronics (ISO 11608-
4:2022)
Systèmes d'injection à aiguille pour usage médical - Kanülenbasierte Injektionssysteme zur medizinischen
Exigences et méthodes d'essai - Partie 4: Systèmes Verwendung - Anforderungen und Prüfverfahren - Teil
d'injection à aiguille contenant de l'électronique (ISO 4: Kanülenbasierte Injektionssysteme, die
11608-4:2022) elektronische Bauteile enthalten (ISO 11608-4:2022)
This European Standard was approved by CEN on 2 January 2022.
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, Turkey 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11608-4:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11608-4:2022) has been prepared by Technical Committee ISO/TC 84 "Devices
for administration of medicinal products and catheters" in collaboration with 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 November 2022, and conflicting national standards
shall be withdrawn at the latest by November 2022.
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 11608-4:2007.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11608-4:2022 has been approved by CEN as EN ISO 11608-4:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 11608-4
Second edition
2022-04
Needle-based injection systems for
medical use — Requirements and test
methods —
Part 4:
Needle-based injection systems
containing electronics
Systèmes d'injection à aiguille pour usage médical — Exigences et
méthodes d’essai —
Partie 4: Systèmes d'injection à aiguille contenant de l'électronique
Reference number
ISO 11608-4:2022(E)
ISO 11608-4:2022(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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii
ISO 11608-4:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 Abbreviated terms .11
5 General requirements .11
5.1 Conditions for application of NIS-E . 11
5.2 General design requirements . 12
5.3 Risk approach and usability engineering .12
6 General requirements for testing .13
6.1 Type tests .13
6.2 Number of samples .13
6.3 Ambient temperature, humidity, atmospheric pressure . 18
7 Identification and marking of NIS-E .18
8 Protection against electrical hazards .18
8.1 General . 18
8.2 Humidity preconditioning treatment. 18
8.3 Requirements and test methods . 19
8.3.1 General . 19
8.3.2 Applied parts . 19
8.3.3 Requirements related to power sources . 21
8.3.4 Limitation of current for accessible parts and applied parts .22
8.4 Separation of parts (Type X and Type Y) . 22
8.4.1 Means of protection (MOP) . 22
8.4.2 Separation of patient connection . 23
8.4.3 Maximum mains voltage . 24
8.4.4 Working voltage . 24
8.5 Patient leakage current and touch current (Type X and Type Y NIS-E) . 25
8.5.1 General . 25
8.5.2 Measurement of patient leakage current .29
8.5.3 Measurement of touch current . 32
8.6 Insulation (Type X and Type Y) . 33
8.6.1 General . 33
8.6.2 Distance through solid insulation or use of thin sheet material .33
8.6.3 Dielectric strength .34
8.7 Insulation other than wire insulation .34
8.7.1 Mechanical strength and resistance to heat.34
8.8 Creepage distances and air clearances (Type X and Type Y NIS-E) . 35
8.8.1 General . 35
8.9 Specific hazardous situations .36
8.9.1 General .36
8.9.2 Emissions, deformation of enclosure or exceeding maximum temperature .36
8.9.3 Exceeding leakage current or voltage limits .38
8.9.4 Specific mechanical hazards .38
8.10 Single fault conditions (Type X and Type Y) .
...