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DENTISTRY - STERILE INJECTION NEEDLES FOR SINGLE USE

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2010

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements of assembled needle and hub
5 Requirements of needle tubing
6 Requirements of hub
7 Requirements of the primary container
8 Sterility
9 Labelling
Annex A (informative) Imperial thread sizes
Bibliography

Provides dimensional and performance requirements for sterile injection needles for single use which are used in dental cartridge syringes complying with ISO 9997 for injection of dental local anaesthetics.

DocumentType	Standard
Pages	18
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 7885:2001

Standards	Relationship
NF EN ISO 7885 : 2010	Identical
EN ISO 7885:2010	Identical
NEN EN ISO 7885 : 2010	Identical
NBN EN ISO 7885 : 2010	Identical
SN EN ISO 7885:2010	Identical
NS EN ISO 7885 : 2010	Identical
UNI EN ISO 7885 : 2010	Identical
BS EN ISO 7885:2010	Identical
UNE-EN ISO 7885:2010	Identical
ISO 7885:2010	Identical
DIN EN ISO 7885:2010-06	Identical

ISO 21533:2003	Dentistry Reusable cartridge syringes intended for intraligamentary injections
ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 7405:2008	Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 9997:1999	Dental cartridge syringes
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
ISO 1942:2009	Dentistry Vocabulary
ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO/TS 11135-2:2008	Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 11499:2014	Dentistry — Single-use cartridges for local anaesthetics
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 6009:2016	Hypodermic needles for single use Colour coding for identification

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I.S. EN ISO 7885:2010

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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