I.S. EN ISO 80369-7:2017 COR 2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
SMALL-BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS (ISO 80369-7:2016, CORRECTED VERSION 2016-12-01)
Hardcopy , PDF
01-02-2019
English
04-07-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Dimensional requirements for luer
connectors
6 Performance requirements
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 luer connectors for
intravascular or hypodermic applications
Annex F (informative) - Summary of luer connector
design requirements for intravascular or
hypodermic applications
Annex G (informative) - Summary of assessment of the
design of the luer connector for intravascular or
hypodermic applications
Annex H (informative) - Reference to the essential
principles
Annex I (informative) - Terminology - Alphabetized index
of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169]
aimed to be covered
Defines dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
| DevelopmentNote |
Supersedes I.S. EN 1707 & I.S. EN 20594-1. (06/2017)
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| EN ISO 80369-7:2017 | Identical |
| ISO 80369-7:2016 | Identical |
| ISO 11040-4:2015 | Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| ISO 80369-20:2015 | Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods |
| EN ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) |
| EN ISO 80369-6 : 2016 COR 2016 | SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 6: CONNECTORS FOR NEURAXIAL APPLICATIONS (ISO 80369-6:2016, CORRECTED VERSION 2016-11-15) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| ISO 8638:2010 | Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 10241-2:2012 | Terminological entries in standards — Part 2: Adoption of standardized terminological entries |
| 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 |
| ISO 527-2:2012 | Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics |
| 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 80369-6:2016 | Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications |
| 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 |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 10241-1:2011 | Terminological entries in standards — Part 1: General requirements and examples of presentation |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 178:2010 | Plastics Determination of flexural properties |
| 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 |
| ISO 80369-3:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications |
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