14/30288421 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO/IEC 80369-6 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS
Hardcopy , PDF
English
30-04-2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for SMALL-BORE CONNECTORS
for neuraxial APPLICATIONS
6 Performance requirements
Annex A (informative) - Rationale and guidance
ANNEX B (normative) - SMALL-BORE CONNECTORS for neuraxial
APPLICATIONS
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 neuraxial APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE CONNECTOR criteria
and requirements for neuraxial APPLICATIONS
ANNEX G (informative) - Summary of assessment of the design of the
SMALL BORE CONNECTORS for neuraxial APPLICATIONS
Annex H (informative) - Mechanical tests for verifying
NON-INTERCONNECTABLE characteristics
Annex I (informative) - Reference to the Essential Principles
Bibliography
Terminology - Alphabetized index of defined terms
Annex ZA (informative) - Relationship between this Document and
the Essential Requirements of EU Directive 93/42/EEC
BS EN ISO/IEC 80369-6.
| Committee |
CH/210/5
|
| DocumentType |
Draft
|
| Pages |
58
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 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 |
| 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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