Prefilled syringes Seals for dental local anaesthetic cartridges

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

29-02-2012

Publisher

British Standards Institution

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 seals for dental local anaesthetic cartridges intended for single use only.

This part of ISO11040 specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.

Committee	CH/212
DevelopmentNote	Supersedes 10/30216808 DC. (02/2012)
DocumentType	Standard
Pages	16
PublisherName	British Standards Institution
Status	Current
Supersedes	10/30216808 DC : 0

Standards	Relationship
ISO 11040-3:2012	Identical

ISO 11040-2:2011	Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges
ISO 8871-1:2003	Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 7885:2010	Dentistry Sterile injection needles for single use
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 7405:2008	Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 3302-1:2014	Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 9997:1999	Dental cartridge syringes
ISO 8872:2003	Aluminium caps for transfusion, infusion and injection bottles — General requirements and test methods
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)
ISO 13926-2:2011	Pen systems Part 2: Plunger stoppers for pen-injectors for medical use
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 3302-2:2008	Rubber Tolerances for products Part 2: Geometrical tolerances
ISO 8871-5:2016	Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
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

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BS ISO 11040-3:2012

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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