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oSIST prEN ISO 11608-4:2016
01-maj-2016
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del:
Peresa za injiciranje z elektronskimi elementi (ISO/DIS 11608-4:2016)
Needle-based injection systems for medical use - Requirements and test methods - Part
4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile
enthalten (ISO/DIS 11608-4:2016)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 4: Systèmes d'injection à aiguille électroniques (ISO/DIS 11608-4:2016)
Ta slovenski standard je istoveten z: prEN ISO 11608-4
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
oSIST prEN ISO 11608-4:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11608-4:2016
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oSIST prEN ISO 11608-4:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11608-4
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2016-02-11 2016-05-10
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 électroniques
ICS: 11.040.25
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11608-4:2015(E)
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 SUPPORTING DOCUMENTATION. ISO 2015
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oSIST prEN ISO 11608-4:2016
ISO/DIS 11608-4:2015(E)
ISO/DIS 11608-4:2016
Contents
Foreword . 4
Introduction. 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Symbols and abbreviated terms . 24
5 General requirements . 24
6 General requirements for testing . 24
7 Classification of ENIS . 25
8 Identification, marking and documentation . 25
9 Protection against electrical hazards .
...