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DIN
DIN EN ISO 7886-1:2015-10 (Draft)

DIN EN ISO 7886-1:2015-10 (Draft)

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE

Available format(s)

Hardcopy , PDF

Superseded date

30-08-2018

Language(s)

German

Published date

01-01-2015

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Vorwort
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Benennungen
5 Reinheit
6 Grenzwerte für saure oder basische Bestandteile
7 Grenzwerte für extrahierbare Metalle
8 Gleitmittel
9 Fehlergrenzen für das graduierte Volumen
10 Skaleneinteilung
11 Zylinder
12 Kolben/Kolbenstange
13 Aussenkegel
14 Anforderungen
15 Verpackung
16 Kennzeichnung
Anhang A (normativ) Herstellung der Prüfflüssigkeit
Anhang B (normativ) Prüfung auf Luftdurchlässigkeit
         zwischen Kolben und Zylinder während des
         Ansaugens und auf die Trennung von Kolben
         und Kolbenstange
Anhang C (normativ) Bestimmung des Restvolumens
Anhang D (normativ) Prüfung auf Durchlässigkeit von
         Flüssigkeiten zwischen Kolben und Zylinder
         unter Druck
Anhang E (informativ) Hinweise zu Werkstoffen
Anhang F (informativ) Beispiel für Prüfungen auf
         Unverträglichkeit zwischen Spritzen und
         Injektionslösungen
Anhang G (informativ) Prüfung der zur Kolbenbewegung
         erforderlichen Kräfte
Anhang H (informativ) Symbol für die Kennzeichnung
         'Nicht Wiederverwenden'
Anhang J (informativ) Bibliographie

This standard is included in DIN Handbook 227/1 and 463. Defines requirements for sterile single-use hypodermic plastic syringes for aspiration or injecting of fluids immediately after filling. Does not include syringes to be used with insulin, single-use glass syringes, syringes used with power-driven syringe pumps, prefilled with injection by the manufacturer or supplied as a kit for filling by a pharmacist.

DevelopmentNote
Supersedes DIN 13098-1 and DIN 13150-1 (07/2002) DRAFT 2015 issued in October 2015. (10/2015)
DocumentType
Draft
Pages
85
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
Supersedes

DIN HDBK 463 : 3ED 2014 MEDIZINISCHE GERAETE UND BEHAELTNISSE FUER TRANSFUSION, INFUSION UND INJEKTION
DIN HDBK 227/1 : 4ED 2013 MEDIZINISCHE EINMALPRODUKTE - TRANSFUSIONS-/INFUSIONS- UND INJEKTIONSGERAETE
DIN EN ISO 11070:2015-03 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
DIN EN ISO 7886-3:2010-01 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
DIN EN ISO 22413:2013-10 Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
DIN EN ISO 11608-3:2013-01 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)

DIN EN 1707:1997-01 CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
DIN EN 20594-1:1995-01 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS
DIN ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS

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PDF - German
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