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I.S. EN ISO 7885:2010

Current

Current

The latest, up-to-date edition.

DENTISTRY - STERILE INJECTION NEEDLES FOR SINGLE USE

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2010

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.


Dates of withdrawal of national standards are available from NSAI.

€28.00
Excluding VAT

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

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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