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DIN
DIN ISO 11040-2 E : 2012

DIN ISO 11040-2 E : 2012

Current

Current

The latest, up-to-date edition.

PREFILLED SYRINGES - PART 2: PLUNGER STOPPERS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES (ISO 11040-2:2011)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2012

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Classification
4 Shape and dimensions
5 Designation
6 Material
7 Requirements
8 Labelling
Annex A (normative) - Leakage test
Bibliography

Describes the shape, dimensions, material, performance requirements and labelling of plunger stoppers for dental local anaesthetic cartridges intended for single use only.

DocumentType
Standard
Pages
11
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

Standards Relationship
ISO 11040-2:2011 Identical

ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
DIN ISO 11040-3:2014-05 PREFILLED SYRINGES - PART 3: SEALS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES (ISO 11040-3:2012)
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
ISO 2230:2002 Rubber products — Guidelines for storage
ISO 11040-3:2012 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
DIN EN ISO 8871-1:2004-11 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLE IN AQUEOUS AUTOCLAVATES
DIN EN ISO 9997 E : 2000 DENTAL CARTRIDGE SYRINGES
ISO 9997:1999 Dental cartridge syringes
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
DIN EN ISO 8871-4:2006-09 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)
ISO 11499:2014 Dentistry — Single-use cartridges for local anaesthetics
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 11040-1:2015 Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
DIN ISO 11040-1:1993-07 PREFILLED SYRINGES - PART 1: GLASS CYLINDERS FOR DENTAL LOCAL ANAESTHETIC CARTRIDGES (ISO 11040-1:2015)

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Hardcopy - English
PDF - English
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