Detail of YY/T 0916.7-2024

Introduction of YY/T 0916.7-2024

YY/T 0916.7-2024 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications 1 Scope This document specifies 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. Example: Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. Note 1: See Annex A. Note 2: The Luer connector was originally designed for use at pressures up to 300kPa. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: ——haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports); ——haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637); ——infusion system closure piercing connectors (ISO 8536-4). Note 3: Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in YY/T 0916, will be included. Note 4: YY/T 0916.1-2021, Clause 7, specifies alternative methods of conformance with YY/T 0916.1-2021, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document. 2 Normative references The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. YY/T 0916.1-2021 Small-bore connectors for liquids and gases in healthcare applications - Part 1:General requirements (ISO 80369-1:2018, IDT) YY/T 0916.6-2022 Small-bore connectors for liquids and gases in healthcare applications - Part 6:Connectors for neuraxial applications (ISO 80369-6:2016, IDT) YY/T 0916.20-2019 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2015, IDT) ISO 14971:2019 Medical devices - Application of risk management to medical devices Note: GB/T 42062-2022 Medical devices - Application of risk management to medical devices. IEC 62366-1:2015 Medical devices - Part 1:Application of usability engineering to medical devices Note: YY/T 1474-2016 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007, IDT) 3 Terms and definitions For the purposes of this document, the terms and definitions given in YY/T 0916.1-2021, YY/T 0916.20-2019, ISO 14971:2019 and IEC 62366-1:2015 (as shown in Annex J) and the following apply. 3.1 auxiliary dimension dimension derived from other dimensions given for information purposes only [Source: ISO 10209:2012, 4.2] 3.2 Luer connector small-bore connector that contains a conical mating surface with a 6% (Luer) taper intended for use in intravascular or hypodermic applications of medical devices and related accessories Note 1: A Luer connector can be either a Luer slip connector or a Luer lock connector. Note 2: See Annex A. 3.3 Luer slip connector Luer connector without a lock Note 1: The Luer slip connector is indicated by the abbreviation L1. Note 2: See Annex A. 3.4 Luer lock connector Luer connector that contains a locking mechanism Note 1: The Luer lock connector is indicated by the abbreviation L2. Note 2: See Annex A. 3.5 normal use operation, including routine inspection and adjustments by any user, and stand-by, according to the instructions for use Note: Normal use should not be confused with intended use. While both include the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, service, transport, etc. as well. [Source: IEC 60601-1:2005+A1:2012, 3.71, modified - replaced “operator” with “user”.] 3.6 rated (value) term referring to a value assigned by the manufacturer for a specified operating condition [Source: IEC 60601-1:2005, 3.97] 3.7 rigid material material with a modulus of elasticity either in flexure or in tension greater than 3 433MPa Example: Metals, glass, some fiber-reinforced polymers and high-performance polymers. 3.8 semi-rigid material material with a modulus of elasticity either in flexure or in tension, between 700MPa and 3 433MPa Example: Thermoplastics. 4 General requirements 4.1 General requirements for Luer connector

Contents of YY/T 0916.7-2024

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