EN ISO 7886-2:2020

Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)

This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.

Sterile Einmalspritzen für medizinische Zwecke - Teil 2: Spritzen zur Verwendung mit Spritzenpumpen (ISO 7886-2:2020)

Dieses Dokument legt die Anforderungen für sterile Einmalspritzen mit einem Nennvolumen von 1 ml und größer fest, die aus Kunststoffen hergestellt und zur Verwendung mit Druckinfusionsapparaten vorgesehen sind.
Dieses Dokument gilt nicht für selbstblockierende Spritzen (ISO 7886 3 [2]), Insulinspritzen (ISO 8537 [3]), Einmalspritzen aus Glas, vom Hersteller mit injizierbarer Zubereitung vorgefüllte Spritzen sowie zusammen mit der injizierbaren Zubereitung gelieferte Beilagespritzen, die vom Apotheker gefüllt werden. Es behandelt nicht die Kompatibilität mit Injektionsflüssigkeiten.

Seringues hypodermiques stériles, non réutilisables - Partie 2: Seringues pour pousse-seringues électriques (ISO 7886-2:2020)

Le présent document spécifie les exigences relatives aux seringues hypodermiques stériles non réutilisables, ayant une capacité nominale égale ou supérieure à 1 ml, fabriquées en matières plastiques et destinées à être utilisées avec des pousse-seringues électriques.
Le présent document ne s'applique pas aux seringues dotées d'un système autobloquant (ISO 7886‑3[2]), aux seringues à insuline (ISO 8537[3]), aux seringues en verre non réutilisables, aux seringues préremplies avec le produit d'injection par le fabricant et aux seringues fournies avec le produit d'injection sous forme de kit par un pharmacien. Il ne traite pas de la compatibilité avec les liquides d'injection.

Sterilne podkožne injekcijske brizge za enkratno uporabo - 2. del: Injekcijske brizge za injiciranje z injekcijskimi črpalkami (ISO 7886-2:2020)

General Information

• Status: Published
• Publication Date: 12-May-2020
• Withdrawal Date: 29-Nov-2020
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 13-May-2020
• Completion Date: 13-May-2020
• Ref Project: SIST EN ISO 7886-2:2020 - Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)

Relations

• Replaces: EN ISO 7886-2:1997 - Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:1996)
• Effective Date: 01-Aug-2018

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2020
Nadomešča:
SIST EN ISO 7886-2:2000
Sterilne podkožne injekcijske brizge za enkratno uporabo - 2. del: Injekcijske
brizge za injiciranje z injekcijskimi črpalkami (ISO 7886-2:2020)
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven
syringe pumps (ISO 7886-2:2020)
Sterile Einmalspritzen für medizinische Zwecke - Teil 2: Spritzen zur Verwendung mit
Spritzenpumpen (ISO 7886-2:2020)
Seringues hypodermiques stériles, non réutilisables - Partie 2: Seringues pour pousse-
seringues mus par un moteur (ISO 7886-2:2020)
Ta slovenski standard je istoveten z: EN ISO 7886-2:2020
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 7886-2
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 11.040.25 Supersedes EN ISO 7886-2:1997
English Version
Sterile hypodermic syringes for single use - Part 2:
Syringes for use with power-driven syringe pumps (ISO
7886-2:2020)
Seringues hypodermiques stériles, non réutilisables - Sterile Einmalspritzen für medizinische Zwecke - Teil
Partie 2: Seringues pour pousse-seringues électriques 2: Spritzen zur Verwendung mit Spritzenpumpen (ISO
(ISO 7886-2:2020) 7886-2:2020)
This European Standard was approved by CEN on 27 April 2020.

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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-2:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 7886-2:2020) 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 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
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 7886-2:1997.
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 7886-2:2020 has been approved by CEN as EN ISO 7886-2:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 7886-2
Second edition
2020-04
Sterile hypodermic syringes for
single use —
Part 2:
Syringes for use with power-driven
syringe pumps
Seringues hypodermiques stériles, non réutilisables —
Partie 2: Seringues pour pousse-seringues électriques
Reference number
ISO 7886-2:2020(E)
©
ISO 2020
ISO 7886-2:2020(E)
© ISO 2020
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: [phone]
Fax: [phone]
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Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 7886-2:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 1
5 General requirements . 2
6 Limits for acidity or alkalinity. 2
7 Limits for extractable metals . 2
8 Lubricant . 2
9 Tolerance on graduated capacity . 2
10 Graduated scale . 2
11 Syringe design . 2
12 Piston/plunger assembly . 4
12.1 Design . 4
12.2 Fit of plunger stopper/plunger in barrel . 4
13 Nozzle . 4
13.1 Conical fitting . 4
13.2 Nozzle lumen . 4
14 Performance . 4
14.1 Dead space . 4
14.2 Freedom from air and liquid leakage past the plunger stopper . 4
14.3 Short-term flow rate error . 4
14.4 Pump forces . 5
14.5 Syringe compliance . 5
15 Packaging . 6
15.1 Unit packaging and self-contained syringe units . 6
15.1.1 Unit packaging . 6
15.1.2 Self-contained syringe units . 6
15.2 Multiple unit pack. 6
15.3 User packaging . 6
16 Information supplied by the manufacturer . 6
16.1 General . 6
16.2 Syringes . 6
16.2.1 General. 6
16.2.2 Additional marking for self-contained syringe units. 7
16.3 Unit packaging . 7
16.4 Multiple unit packs . 7
16.4.1 General. 7
16.4.2 Multiple unit packs with self-contained syringes. 7
16.5 User packaging . 7
16.6 Storage container . 7
16.7 Transport wrapping .
...