13/30255554 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 80369-7 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS WITH 6% (LUER) TAPER FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS
Hardcopy , PDF
English
31-07-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for LUER CONNECTORS
6 Performance requirements
7 Design guidance
Annex A (informative) - Rationale and guidance
Annex B (normative) - LUER CONNECTORS
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 the usability requirements
for SMALL-BORE CONNECTORS for intravascular or
hypodermic APPLICATIONS
Annex F (informative) - Summary of SMALL-BORE CONNECTOR
criteria and requirements for intravascular or
hypodermic APPLICATIONS
Annex G (informative) - Summary of assessment of the design of
the SMALL-BORE CONNECTOR for intravascular or
hypodermic APPLICATIONS
Annex H (informative) - Historical plug and ring test gauges
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 80369-7
| Committee |
CH/210/5
|
| DocumentType |
Draft
|
| Pages |
52
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 11040-4:2015 | Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
| ISO 8637:2010 | Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ISO 8638:2010 | Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| 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 8536-4:2010 | Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |
| 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 |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
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