prEN ISO 7886-3

SLOVENSKI STANDARD
01-februar-2017
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Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose
immunization (ISO/DIS 7886-3:2016)
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für
die Injektion mit fixer Impfstoffdosis (ISO/DIS 7886-3:2016)
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes
pour vaccination à dose fixe (ISO/DIS 7886-3:2016)
Ta slovenski standard je istoveten z: prEN ISO 7886-3
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.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 7886-3
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2016-11-28 2017-02-19
Sterile hypodermic syringes for single use —
Part 3:
Auto-disabled syringes for fixed-dose immunization
Seringues hypodermiques stériles, non réutilisables —
Partie 3: Seringues autobloquantes pour vaccination à dose fixe
ICS: 11.040.25
THIS DOCUMENT IS A DRAFT CIRCULATED
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THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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NATIONAL REGULATIONS.
ISO/DIS 7886-3:2016(E)
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©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2016

ISO/DIS 7886-3:2016(E)
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved

ISO/DIS 7886-3:2016(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Nomenclature . 2
5 Requirements . 3
5.1 General Requirements . 3
6 Cleanliness . 4
7 Limits for acidity or alkalinity. 4
8 Limits for extractable metals . 4
9 Lubricant . 4
10 Tolerance on nominal capacity . 4
11 Graduated scale . 5
11.1 Scale . 5
11.2 Position of scale . 5
12 Barrel . 5
12.1 Dimensions . 5
12.2 Barrel flanges . 5
13 Plunger stopper/plunger assembly. 5
13.1 Design . 5
13.2 Fit of the plunger stopper/plunger in the barrel . 6
13.3 Fiducial line . 6
14 Needle . 6
14.1 Integrated needle . 6
14.2 Non-integrated needle . 6
14.3 Sharps protection features . 6
15 Performance . 7
15.1 General . 7
15.2 Dead space . 7
15.3 Freedom from air and liquid leakage . 7
15.4 Auto-disable feature . 7
15.5 Performance after shipping . 7
15.6 Guidance on materials . 7
16 Packaging . 8
16.1 Unit packaging providing sterile barrier . 8
16.2 User packaging . 8
17 Information supplied by the manufacturer . 8
17.1 General . 8
17.2 Syringes . 8
17.3 Unit packaging providing sterile barrier . 8
17.4 User packaging . 9
17.5 Storage containers . 9
17.6 Transport wrapping .10
Annex A (normative) Method for preparation of extracts .12
Annex B (informative) Test method for forces required to operate piston .13
ISO/DIS 7886-3:2016(E)
Annex C (normative) Test method for testing auto-disable feature .15
Bibliography .16
iv © ISO 2016 – All rights reserved

ISO/DIS 7886-3:2016(E)
Foreword
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