EN ISO 7886-3:2005

Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

2005-04-05 - Work item transferred from 00205166 following resolution 2 of the 25th BT/TCMG

Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2005)

Dieser Teil von ISO 7886 legt Anforderungen für sterile Einmalspritzen aus Kunststoff und nichtrostendem Stahl mit und ohne Kanüle fest, die für das Aufziehen von Flüssigkeiten oder für die Injektion von Flüssigkeiten unmittelbar nach ihrem Befüllen vorgesehen sind. Nach Abgabe einer festgelegten Dosis einer medizinischen Substanz wird die Spritze automatisch unbrauchbar gemacht.
Dieser Teil von ISO 7886 gilt nicht für Insulinspritzen (Festlegungen in ISO 8537), Glasspritzen (Festlegungen in ISO 595), Spritzen für Druckinfusionsapparate (Festlegungen in ISO 7886-2), selbstblockierende Spritzen für die Abgabe unterschiedlicher Dosen und zur Vorfüllung ausgelegte Spritzen. Er behandelt nicht die Verträglichkeit mit Injektionsflüssigkeiten bzw. Impfstoffen.
ANMERKUNG   Ein vierter Teil von ISO 7886 ist in Vorbereitung, der selbstblockierende Spritzen für allgemeine Zwecke behandelt.

Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes pour vaccination à dose fixe (ISO 7886-3:2005)

Sterilne podkožne injekcijske brizge za enkratno uporabo - 3. del: Brizge za točno določen odmerek imunizacije s sistemom za samouničenje (ISO 7886-3:2005)

General Information

• Status: Withdrawn
• Publication Date: 28-Feb-2005
• Withdrawal Date: 22-Sep-2009
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/SS S03 - Syringes
• Drafting Committee: CEN/SS S03 - Syringes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 23-Sep-2009
• Completion Date: 23-Sep-2009
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 7886-3:2005 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

Relations

• Replaced By: EN ISO 7886-3:2009 - Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
• Effective Date: 28-Jan-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7886-3:2005
01-junij-2005
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO%UL]JH]DWRþQR
GRORþHQRGPHUHNLPXQL]DFLMHVVLVWHPRP]DVDPRXQLþHQMH,62
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose
immunization (ISO 7886-3:2005)
Sterile Einmalspritzen für medizinische Zwecke - Teil 3: Selbstblockierende Spritzen für
die Injektion mit fixer Impfstoffdosis (ISO 7886-3:2005)
Seringues hypodermiques stériles, non réutilisables - Partie 3: Seringues autobloquantes
pour vaccination a dose fixe (ISO 7886-3:2005)
Ta slovenski standard je istoveten z: EN ISO 7886-3:2005
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-3:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005

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SIST EN ISO 7886-3:2005


INTERNATIONAL ISO
STANDARD 7886-3
First edition
2005-03-01


Sterile hypodermic syringes for single
use —
Part 3:
Auto-disable syringes for fixed-dose
immunization
Seringues hypodermiques stériles, non réutilisables —
Partie 3: Seringues autobloquantes pour vaccination à dose fixe




Reference number
ISO 7886-3:2005(E)
©
ISO 2005

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SIST EN ISO 7886-3:2005
ISO 7886-3:2005(E)
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ii © ISO 2005 – All rights reserved

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SIST EN ISO 7886-3:2005
ISO 7886-3:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Nomenclature . 2
5 Cleanliness . 3
6 Limits for acidity or alkalinity . 3
7 Limits for extractable metals . 3
8 Lubricant.
...