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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Freedom from leakage of anaesthetic solution
4.2 Force needed for plunger movement
4.3 Size of air bubble
4.4 Biocompatibility
4.5 Extractable volume
4.6 External dimensions of the assembled cartridge
ISO 15223-1:2012 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
ISO 1942:2009 Dentistry -- Vocabulary
ISO 21533:2003 Dentistry -- Reusable cartridge syringes intended for intraligamentary injections
ISO 15223-1:2012 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
ISO 1942:2009 Dentistry -- Vocabulary
ISO 21533:2003 Dentistry -- Reusable cartridge syringes intended for intraligamentary injections
ISO 7885:2010 Dentistry -- Sterile injection needles for single use
ISO 9997:1999 Dental cartridge syringes