Standard Swedish standard · SS-EN ISO 80369-1:2011

Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)

Status: Withdrawn

· Replaced by: SS-EN ISO 80369-1:2018
Buy this standard

Standard Swedish standard · SS-EN ISO 80369-1:2011

Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
Subscribe on standards - Read more Dölj
Price: 1 152 SEK
standard ikon pdf

PDF

Price: 1 152 SEK
standard ikon

Paper

Price: 1 843,20 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less
Scope
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. NOTE 1 It is intended that new designs of SMALL-BORE CONNECTORS will be included in this series of standards after they have been assessed according to the PROCEDURE given in Clause 6.

Subjects

Anaesthetic, respiratory and reanimation equipment (11.040.10) Transfusion, infusion and injection equipment (11.040.20)


Buy this standard

Standard Swedish standard · SS-EN ISO 80369-1:2011

Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
Subscribe on standards - Read more Dölj
Price: 1 152 SEK
standard ikon pdf

PDF

Price: 1 152 SEK
standard ikon

Paper

Price: 1 843,20 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-76250

Edition: 1

Approved: 1/10/2011

No of pages: 36

Replaces: SS-EN 15546-1:2008

Replaced by: SS-EN ISO 80369-1:2018