RO
SR EN ISO 80369-1:2011
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
ISO 80369-1:2010 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for: breathing systems and driving gases, enteral and gastric, urethral and urinary, limb cuff inflation, neuraxial devices, and intravascular or hypodermic. Small-bore connectors as specified in ISO 80369-1:2010 are non-interconnectable with: the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; the temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and the nipples of EN 13544-2:2002. ISO 80369-1:2010 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical
Status :
Withdrawn
Approval date : 5/31/2011
Romanian version publish date : 12/23/2015
Withdrawal date : 4/25/2019
Number of pages : 28
ICS : 11.040.10 Anaesthetic, respiratory and reanimation equipment,11.040.20 Tranfusion, infusion and injection equipment
Technical Committee : 377 - Medical devices
- Replaces SR EN 15546-1:2008
- Normative reference SR EN ISO 5356-2:2008
- Normative reference SR EN 62366:2008
- Normative reference SR EN ISO 14971:2012
- Normative reference SR EN 13544-2:2003
- Normative reference SR EN ISO 5356-1:2004
- Replaced by SR EN ISO 80369-1:2019