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

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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