EN ISO 8537:2016

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

ISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.
The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.
ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).

Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2016)

Diese Internationale Norm legt Anforderungen an und Prüfverfahren für leere, sterile Einmalspritzen mit oder ohne Kanüle fest, die aus Kunststoffmaterialien hergestellt und ausschließlich zur Injektion von Insulin vorgesehen sind, mit dem die Spritzen vom Endverbraucher befüllt werden. Diese Internationale Norm gilt für Einmalspritzen, die für die Anwendung am Menschen und für verschiedene Insulinkonzentrationen vorgesehen sind.
Die in dieser Internationalen Norm festgelegten Insulinspritzen sind zum unverzüglichen Gebrauch (d. h. Insulininjektion) nach dem Befüllen bestimmt und sind nicht dafür vorgesehen, Insulin über eine längere Zeitdauer aufzubewahren.
Diese Norm gilt nicht für Einmalspritzen aus Glas, Spritzen zur Verwendung mit Spritzenpumpen, vom Hersteller vorgefüllte Spritzen und Spritzen, die für eine Lagerung nach dem Befüllen vorgesehen sind (z. B. in einem Satz, der zum Befüllen durch einen Apotheker bestimmt ist).

Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2016)

ISO 8537:2016 spécifie des exigences et des méthodes d'essai applicables aux seringues stériles vides non réutilisables, avec ou sans aiguille, constituées de plastique et uniquement destinées à l'injection d'insuline, avec laquelle les seringues sont remplies par l'utilisateur final. La présente Norme internationale concerne les seringues non réutilisables utilisées uniquement chez l'être humain et remplies d'insuline en concentrations variables.
Les seringues à insuline décrites dans la présente Norme internationale sont prévues pour être utilisées (par exemple, injection d'insuline) immédiatement après leur remplissage et ne sont pas adaptées pour contenir de l'insuline pendant de longues périodes.
ISO 8537:2016 exclut les seringues non réutilisables en verre, les seringues utilisables avec les pousse-seringues électriques, les seringues pré-remplies par le fabricant et les seringues prévues pour être conservées après leur remplissage (par exemple, dans un kit prévu pour être rempli par un pharmacien).

Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO 8537:2016)

Ta mednarodni standard določa zahteve in preskusne metode za prazne, sterilne
injekcijske brizge za enkratno uporabo, z iglo ali brez nje, ki so izdelane iz plastike in namenjene zgolj za vbrizganje
inzulina, pri čemer injekcije napolni končni uporabnik. Ta mednarodni standard zajema injekcijske brizge, ki so namenjene za enkratno uporabo samo pri ljudeh, z inzulinom v različnih koncentracijah.
Injekcijske brizge za inzulin, ki so določene v tem mednarodnem standardu, so namenjene za uporabo (tj. injekcija inzulina) takoj po polnjenju in ne smejo vsebovati inzulina dlje časa.
V tem mednarodnem standardu niso zajete injekcijske brizge za enkratno uporabo, izdelane iz stekla, injekcijske brizge za uporabo z injekcijskimi črpalkami, injekcijske brizge, ki jih predhodno napolni proizvajalec, in injekcijske brizge, ki so namenjene za shranjevanje po polnjenju (npr. v kompletu, ki ga napolni farmacevt).

General Information

• Status: Published
• Publication Date: 12-Apr-2016
• Withdrawal Date: 30-Oct-2016
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• 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-Apr-2016
• Completion Date: 13-Apr-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 8537:2016 - Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

Relations

• Replaces: EN ISO 8537:2008 - Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8537:2016
01-junij-2016
Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO
8537:2016)
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2016)
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2016)
Ta slovenski standard je istoveten z: EN ISO 8537:2016
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 8537:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8537:2016

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SIST EN ISO 8537:2016


EN ISO 8537
EUROPEAN STANDARD

NORME EUROPÉENNE

April 2016
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8537:2008
English Version

Sterile single-use syringes, with or without needle, for
insulin (ISO 8537:2016)
Seringues à insuline, stériles, non réutilisables, avec ou Sterile Insulin-Einmalspritzen mit oder ohne Kanüle
sans aiguille (ISO 8537:2016) (ISO 8537:2016)
This European Standard was approved by CEN on 27 February 2016.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8537:2016 E
worldwide for CEN national Members.

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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC . 5
2

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SIST EN ISO 8537:2016
EN ISO 8537:2016 (E)
European foreword
This document (EN ISO 8537:2016) 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 October 2016, and conflicting national standards shall
be withdrawn at the latest by October 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 8537:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
The following referenced documents are indispensable for the application of this document.
F
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