YY/T 0916.7-2024 Small-bore connectors for liquids and gases in healthcare applications—Part 7:Connectors for intravascular or hypodermic applications (English)
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General requirements for Luer connector
4.2 Type tests
5 Dimensional requirements for Luer connectors
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
6.1.2 Leakage by pressure decay
6.1.3 Positive pressure liquid leakage
6.2 Sub-atmospheric pressure air leakage
6.3 Stress cracking
6.4 Resistance to separation from axial load
6.5 Resistance to separation from unscrewing
6.6 Resistance to overriding
Annex A (Informative) Rationale and guidance for the contents of this document adopted from ISO 80369-7:2021, Annex A
A.1 General guidance
A.2 Rationale for particular clauses and subclauses
Annex B (Normative) Luer connectors
Annex C (Normative) Reference connectors
C.1 General requirements for reference connectors
C.2 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
E.1 User profile
E.2 Use scenarios
E.3 Use environments
E.4 Other attributes
E.5 Generic user needs
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
G.1 General
G.2 Summary of the engineering analysis of the design
G.3 Summary of the design verification
G.4 Summary of the design validation
G.5 Summary of the design review
Annex H (Informative) Reference to the essential principles
Annex I (Informative) Reference to the general safety and performance requirements
Annex J (Informative) Terminology - Alphabetized index of defined terms
Bibliography
Figure A.1 Lug corners that can interfere
Figure A.2 Area of potential interference
Figure B.1 Male Luer slip connector (L1)
Figure B.2 Female Luer slip connector (L1)
Figure B.3 Male Luer lock connector (L2), with fixed collar
Figure B.4 Male Luer lock connector (L2), with rotatable collar
Figure B.5 Female Luer lock connector (L2)
Figure B.6 Female Luer lock connector with lugs at right angle to axis (L2), variant A
Figure B.7 Female Luer lock connector with lugs at right angle to axis (L2), variant B
Figure B.8 Female Luer lock connector with lugs at right angle to axis (L2), variant C
Figure C.1 Female reference Luer lock connector for testing male Luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics
Figure C.2 Male reference Luer slip connector for testing female Luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics
Figure C.3 Female reference Luer lock connector for testing male Luer lock connector for separation from axial load and resistance to overriding
Figure C.4 Male reference Luer lock connector for testing female Luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics
Figure C.5 Female reference Luer slip connector for testing male Luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics
Figure C.6 Male reference connector for testing female Luer lock connector for separation from axial load and resistance to overriding
Figure G.1 Illustration Luer connector male to N1 male misconnection
Table B.1 Male Luer slip connector dimensions (L1)
Table B.2 Female Luer slip connector dimensions (L1)
Table B.3 Male Luer lock connector, with fixed collar dimensions (L2)
Table B.4 Male Luer lock connector (L2), with rotatable collar dimensions
Table B.5 Female Luer lock connector dimensions (L2)
Table B.6 Female Luer lock connector dimensions (L2), variant A
Table B.7 Female Luer lock connector dimensions (L2), variant B
Table B.8 Female Luer lock connector dimensions (L2), variant C
Table D.1 Examples of medical devices with connections within this application and their attributes
Table E.1 User profile
Table E.2 Use scenarios
Table F.1 Luer connector specific design requirements for intravascular or hypodermic applications
Table G.1 Summary of possible misconnection from CAD analysis
Table H.1 Correspondence between this document and the essential principles
Table I.1 Correspondence between this document and the general safety and performance requirements
Table I.2 Correspondence between this document and relevant essential health and safety requirements from Directive 2006/42/EC on machinery
YY/T 0916.7-2024 Small-bore connectors for liquids and gases in healthcare applications—Part 7:Connectors for intravascular or hypodermic applications (English)
Standard No.
YY/T 0916.7-2024
Status
valid
Language
English
File Format
PDF
Word Count
32760 words
Translation Price(USD)
1310.4
Implemented on
2026-7-20
Delivery
via email in 1~8 business day
Detail of YY/T 0916.7-2024
Standard No.
YY/T 0916.7-2024
English Name
Small-bore connectors for liquids and gases in healthcare applications—Part 7:Connectors for intravascular or hypodermic applications
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 General requirements for Luer connector
4.2 Type tests
5 Dimensional requirements for Luer connectors
6 Performance requirements
6.1 Fluid leakage
6.1.1 Fluid leakage requirement
6.1.2 Leakage by pressure decay
6.1.3 Positive pressure liquid leakage
6.2 Sub-atmospheric pressure air leakage
6.3 Stress cracking
6.4 Resistance to separation from axial load
6.5 Resistance to separation from unscrewing
6.6 Resistance to overriding
Annex A (Informative) Rationale and guidance for the contents of this document adopted from ISO 80369-7:2021, Annex A
A.1 General guidance
A.2 Rationale for particular clauses and subclauses
Annex B (Normative) Luer connectors
Annex C (Normative) Reference connectors
C.1 General requirements for reference connectors
C.2 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
E.1 User profile
E.2 Use scenarios
E.3 Use environments
E.4 Other attributes
E.5 Generic user needs
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
G.1 General
G.2 Summary of the engineering analysis of the design
G.3 Summary of the design verification
G.4 Summary of the design validation
G.5 Summary of the design review
Annex H (Informative) Reference to the essential principles
Annex I (Informative) Reference to the general safety and performance requirements
Annex J (Informative) Terminology - Alphabetized index of defined terms
Bibliography
Figure A.1 Lug corners that can interfere
Figure A.2 Area of potential interference
Figure B.1 Male Luer slip connector (L1)
Figure B.2 Female Luer slip connector (L1)
Figure B.3 Male Luer lock connector (L2), with fixed collar
Figure B.4 Male Luer lock connector (L2), with rotatable collar
Figure B.5 Female Luer lock connector (L2)
Figure B.6 Female Luer lock connector with lugs at right angle to axis (L2), variant A
Figure B.7 Female Luer lock connector with lugs at right angle to axis (L2), variant B
Figure B.8 Female Luer lock connector with lugs at right angle to axis (L2), variant C
Figure C.1 Female reference Luer lock connector for testing male Luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics
Figure C.2 Male reference Luer slip connector for testing female Luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics
Figure C.3 Female reference Luer lock connector for testing male Luer lock connector for separation from axial load and resistance to overriding
Figure C.4 Male reference Luer lock connector for testing female Luer connectors for leakage, separation from unscrewing, stress cracking and non-interconnectable characteristics
Figure C.5 Female reference Luer slip connector for testing male Luer connectors for leakage, separation from axial load, stress cracking and non-interconnectable characteristics
Figure C.6 Male reference connector for testing female Luer lock connector for separation from axial load and resistance to overriding
Figure G.1 Illustration Luer connector male to N1 male misconnection
Table B.1 Male Luer slip connector dimensions (L1)
Table B.2 Female Luer slip connector dimensions (L1)
Table B.3 Male Luer lock connector, with fixed collar dimensions (L2)
Table B.4 Male Luer lock connector (L2), with rotatable collar dimensions
Table B.5 Female Luer lock connector dimensions (L2)
Table B.6 Female Luer lock connector dimensions (L2), variant A
Table B.7 Female Luer lock connector dimensions (L2), variant B
Table B.8 Female Luer lock connector dimensions (L2), variant C
Table D.1 Examples of medical devices with connections within this application and their attributes
Table E.1 User profile
Table E.2 Use scenarios
Table F.1 Luer connector specific design requirements for intravascular or hypodermic applications
Table G.1 Summary of possible misconnection from CAD analysis
Table H.1 Correspondence between this document and the essential principles
Table I.1 Correspondence between this document and the general safety and performance requirements
Table I.2 Correspondence between this document and relevant essential health and safety requirements from Directive 2006/42/EC on machinery
