BS EN ISO 11499:2014
Current
The latest, up-to-date edition.
Dentistry. Single-use cartridges for local anaesthetics
Hardcopy , PDF
English
30-06-2014
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking
Bibliography
Provides specific performance requirements for single-use dental cartridges of 1,0 ml, 1,7 ml, 1,8 ml and 2,2 ml nominal capacity for use with local anaesthetics.
| Committee |
CH/106
|
| DevelopmentNote |
Renumbers and supersedes BS ISO 11499. 1999 version incorporates amendment 10696 to BS ISO 11499. Supersedes 95/561272 DC. (11/2005) Supersedes 06/30109922 DC. (08/2007) Supersedes 13/30257549 DC. (06/2014)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This International Standard gives specific performance requirements for single-use dental cartridges of 1,0ml, 1,7ml, 1,8ml and 2,2ml nominal capacity for use with local anaesthetics.
It specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure that the cartridge will fit dental cartridge syringes complying with ISO9997 and ISO21533.
Labelling requirements are also specified.
NOTE A list of International Standards for certain types of cartridge component is given in the Bibliography.
| Standards | Relationship |
| NF EN ISO 11499 : 2014 | Identical |
| EN ISO 11499:2014 | Identical |
| UNE-EN ISO 11499:2014 | Identical |
| SN EN ISO 11499:2014 | Identical |
| DIN EN ISO 11499:2014-09 | Identical |
| NEN EN ISO 11499 : 2014 | Identical |
| ISO 11499:2014 | Identical |
| UNI EN ISO 11499 : 2014 | Identical |
| I.S. EN ISO 11499:2014 | Identical |
| NBN EN ISO 11499 : 2014 | Identical |
| NS EN ISO 11499 : 2014 | Identical |
| DIN EN ISO 11499:1999-08 | Identical |
| ISO 11040-2:2011 | Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges |
| ISO 7885:2010 | Dentistry Sterile injection needles for single use |
| ISO 21533:2003 | Dentistry Reusable cartridge syringes intended for intraligamentary injections |
| ISO 7405:2008 | Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
| ISO 11040-3:2012 | Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges |
| ISO 9997:1999 | Dental cartridge syringes |
| ISO 1942:2009 | Dentistry Vocabulary |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 7500-1:2015 | Metallic materials Calibration and verification of static uniaxial testing machines Part 1: Tension/compression testing machines Calibration and verification of the force-measuring system |
| 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 11040-1:2015 | Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges |
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