EN ISO 8537:2008

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)

ISO 8537:2007 specifies requirements and test methods for sterile syringes, with or without needles, solely for the injection of insulin. The syringes are single-use only, primarily for use in humans. It covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).
Sterile syringes specified in ISO 8537:2007 are intended for use soon after filling as they are not suitable for containing insulin over extended periods of time.

Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2007)

Diese Internationale Norm legt Anforderungen und Prüfungen für sterile Insulin-Spritzen mit oder ohne Kanüle
fest, die ausschließlich zur Injektion von Insulin dienen. Diese Einmal-Spitzen sind vorrangig für die
Anwendung am Menschen vorgesehen. Sie gilt für Spritzen zur Verwendung mit Insulin der Konzentration von
40 Einheiten/ml (U-40) und 100 Einheiten/ml (U-100).
Die in dieser Internationalen Norm beschriebenen sterilen Spritzen sind zum alsbaldigen Gebrauch nach dem
Füllen bestimmt, da sie nicht zur Aufbewahrung von Insulin über längere Zeit vorgesehen sind.

Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2007)

L'ISO 8537:2007 spécifie des exigences et des méthodes d'essai applicables aux seringues stériles avec ou sans aiguille destinées uniquement à l'injection d'insuline. Les seringues ne sont pas réutilisables et sont utilisées principalement chez l'homme. Elle couvre les seringues utilisées avec 40 unités d'insuline/ml (U-40) et 100 unités d'insuline/ml (U-100).
Les seringues stériles dans l'ISO 8537:2007 sont prévues pour être utilisées immédiatement après leur remplissage, puisqu'elles ne sont pas adaptées pour contenir de l'insuline pendant de longues périodes.

Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO 8537:2007)

General Information

• Status: Withdrawn
• Publication Date: 01-Jul-2008
• Withdrawal Date: 12-Apr-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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 13-Apr-2016
• Ref Project: SIST EN ISO 8537:2008 - Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)

Relations

• Replaces: EN ISO 8537:1994/A1:2000 - Sterile single-use syringes, with or without needle, for insulin (ISO 8537:1991/DAM 1:2000)
• Effective Date: 22-Dec-2008
• Replaces: EN ISO 8537:1994 - Sterile single-use syringes, with or without needle, for insulin (ISO 8537:1991)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 8537:2016 - Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8537:2008
01-september-2008
1DGRPHãþD
SIST EN ISO 8537:2000
SIST EN ISO 8537:2000/A1:2001
Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO
8537:2007)
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2007)
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:2007)
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille (ISO 8537:2007)
Ta slovenski standard je istoveten z: EN ISO 8537:2008
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 8537:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8537:2008

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SIST EN ISO 8537:2008
EUROPEAN STANDARD
EN ISO 8537
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2008
ICS 11.040.25 Supersedes EN ISO 8537:1994
English Version
Sterile single-use syringes, with or without needle, for insulin
(ISO 8537:2007)
Seringues à insuline, stériles, non réutilisables, avec ou Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO
sans aiguille (ISO 8537:2007) 8537:2007)
This European Standard was approved by CEN on 15 June 2008.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8537:2008: E
worldwide for CEN national Members.

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SIST EN ISO 8537:2008
EN ISO 8537:2008 (E)
Contents Page
Foreword.3

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SIST EN ISO 8537:2008
EN ISO 8537:2008 (E)
Foreword
The text of ISO 8537:2007 has been prepared by Technical Committee ISO/TC 84 “Medical devices for
injections” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
8537:2008 by 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 January 2009, and conflicting national standards shall be withdrawn at
the latest by January 2009.
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 8537:1994.
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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 8537:2007 has been approved by CEN as a EN ISO 8537:2008 without any modification.

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SIST EN ISO 8537:2008

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SIST EN ISO 8537:2008

INTERNATIONAL ISO
STANDARD 8537
Second edition
2007-10-01

Sterile single-use syringes, with or
without needle, for insulin
Seringues à insuline, stériles, non réutilisables, avec ou sans aiguille




Reference number
ISO 8537:2007(E)
©
ISO 2007

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SIST EN ISO 8537:2008
ISO 8537:2007(E)
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