EN ISO 11499:2014
Current
The latest, up-to-date edition.
06-04-2014
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Marking
Bibliography
ISO 11499:2014 gives 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.ISO 11499:2014 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. Labelling requirements are also specified.
| Committee |
CEN/TC 55
|
| DevelopmentNote |
Supersedes PREN ISO 11499. (06/2014)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11499:1999-08 | Identical |
| UNE-EN ISO 11499:2014 | Identical |
| SN EN ISO 11499:2014 | Identical |
| PN EN ISO 11499 : 2014 | Identical |
| NEN EN ISO 11499 : 2014 | Identical |
| BS EN ISO 11499:2014 | Identical |
| NS EN ISO 11499 : 2014 | Identical |
| NF EN ISO 11499 : 2014 | Identical |
| DIN EN ISO 11499:2014-09 | Identical |
| ISO 11499:2014 | Identical |
| UNI EN ISO 11499 : 2014 | Identical |
| I.S. EN ISO 11499:2014 | Identical |
| NBN EN ISO 11499 : 2014 | Identical |
| 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 |
| BS EN ISO 9997:2000 | Dental cartridge syringes |
| UNI EN 1639 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS |
| EN ISO 9997:1999 | Dental cartridge syringes (ISO 9997:1999) |
| I.S. EN ISO 9997:2000 | DENTAL CARTRIDGE SYRINGES |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| 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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