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EN ISO 7885:2010

Current
Current

The latest, up-to-date edition.

Dentistry - Sterile injection needles for single use (ISO 7885:2010)
Published date

15-02-2010

Publisher

Comite Europeen de Normalisation

Foreword
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

ISO 7885:2010 gives 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. It further specifies requirements with respect to their packaging, labelling and colour coding. It does not cover needles for special applications or techniques.Only the materials used for the construction of the needle tubing are specified.

Committee
CEN/TC 55
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

02/563808 DC : DRAFT SEP 2002 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
DIN EN 1639:2010-02 Dentistry - Medical devices for dentistry - Instruments
BS EN 1639:2009 Dentistry. Medical devices for dentistry. Instruments
I.S. EN 1639:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
08/30184602 DC : DRAFT SEP 2008 BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
UNI EN 1639 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments

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 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 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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