14/30292519 DC : 0
NA
Status of Standard is Unknown
BS EN 80369-5 ED 1.0 - SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 5: CONNECTORS FOR LIMB CUFF INFLATION APPLICATIONS
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for SMALL-BORE
CONNECTORS for a sphygmomanometer and cuff
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - SMALL-BORE CONNECTORS
for the limb cuff inflation APPLICATION
Annex C (normative) - Reference CONNECTORS
Annex D (informative) - Assessment of MEDICAL
DEVICES and their attributes with
CONNECTIONS within this APPLICATION
Annex E (informative) - Summary of usability
requirements for SMALL-BORE
CONNECTORS for limb cuff inflation
APPLICATION use
Annex F (informative) - Summary of SMALL-BORE
CONNECTOR criteria and requirements
for limb cuff inflation CONNECTORS
Annex G (informative) - Summary of assessment of
the design of the CONNECTORS for limb
cuff inflation
Annex H (informative) - Obsolete limb cuff
inflation CONNECTOR
Annex I (informative) - Air leakage TEST METHOD
by pressure decay
Annex J (informative) - Resistance to separation
from axial load TEST METHOD
Annex K (informative) - Reference to the Essential
Principles
Bibliography
Terminology - Alphabetized index of defined terms
BS EN 80369-5 Ed 1.0.
| Committee |
CH/210/5
|
| DocumentType |
Draft
|
| Pages |
48
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO 81060-1:2007 | Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type |
| ISO 3040:2016 | Geometrical product specifications (GPS) — Dimensioning and tolerancing — Cones |
| CR 13825:2000 | Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings" |
| ASTM D 790 : 2017 : REDLINE | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| IEC 80601-2-30:2009+AMD1:2013 CSV | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
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