15/30288418 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 80369-2 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 2: CONNECTORS FOR BREATHING SYSTEMS AND DRIVING GASES APPLICATIONS
Hardcopy , PDF
English
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for SMALL-BORE
CONNECTORS for the respiratory APPLICATION
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS
for BREATHING SYSTEMS and driving gases for
respiratory use
ANNEX C (normative) - Reference CONNECTORS for
testing SMALL-BORE CONNECTORS for neuraxial
APPLICATIONS
Annex D (informative) - Assessment of MEDICAL DEVICES
and their attributes with CONNECTIONS within
this APPLICATION
ANNEX E (informative) - Summary of the usability requirements
for SMALL-BORE CONNECTORS for BREATHING SYSTEMS
and driving gases for respiratory use
Annex F (informative) - Summary of SMALL-BORE CONNECTOR
criteria and requirements for BREATHING SYSTEMS
and driving gases for respiratory use APPLICATIONS
Annex G (informative) - Summary of assessment of the design
of the SMALL-BORE CONNECTORS for BREATHING SYSTEMS
and driving gases for respiratory use
Annex H (informative) - Reference to the Essential Principles
Annex I (informative) - Terminology - alphabetized index of
defined terms
Annex ZA (informative) - Relationship between this document and
the Essential Requirements of EU Directive 93/42/EEC
Bibliography
BS EN ISO 80369-2.
| Committee |
CH/210/5
|
| DocumentType |
Draft
|
| Pages |
60
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets |
| ISO 3040:2016 | Geometrical product specifications (GPS) — Dimensioning and tolerancing — Cones |
| ISO 5356-2:2012 | Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors |
| CR 13825:2000 | Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings" |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems |
| ISO/TR 16142:2006 | Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ASTM D 790 : 2017 : REDLINE | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
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