Publication details
| Publication CODE |
Title |
| NBN EN ISO 80369-1:2011 (2010-12) |
SMALL BORE CONNECTORS FOR LIQUIDS AND GASES in HEALTHCARE APPLICATIONS
PART 1: GENERAL REQUIREMENTS |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
60.00 €
|
27 P. |
Description
This part of ISO 80369 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. This International Standard 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 this International Standard 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. This International Standard 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 DEVICES or between ACCESSORIES for different APPLICATIONS and to reduce the RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-Luer CONNECTORS that will be developed under future parts of this series of standards. It does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL-BORE CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.
|
| Class |
C
|
Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
|
EN version
|
FR version
|
DE version
|
|
Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Withdrawn
Replaced by
EN ISO 80369-1:2018
|
|
Origin
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
Approval
| BEC Approval |
2010-12-14 |
| NBN Approval |
2011-01-21 |
| Registration |
156140 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.040.10
, 11.040.20
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2010-12-14 |
| Date of availability (d.a.v.) |
2010-12-15 |
| Date of announcement (d.o.a.) |
2011-03-31 |
| Date of publication (d.o.p.) |
2011-06-30 |
| Date of withdrawal former edition (d.o.w.) |
2011-06-30 |
|
Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
80369-1/ed. 1.0
|
2010-12-15 |
| is identical to |
EN ISO 80369-1:2010
|
|
|
