YY 0585.4-2024 Fluid lines for use with pressure infusion equipment and accessories for single use - Part 4: Check valves
1 Scope
This document specifies the performance requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus.
This document is applicable to check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus and the basic requirements of this document are also applicable to inline check valves.
2 Normative references
The following documents contain provisions 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.
GB 8368 Infusion sets for single use - Gravity feed (GB 8368-2018, ISO 8536-4:2010, MOD)
GB 15810 Sterile syringes for single use (GB 15810-2019, ISO 7886-1:2017, MOD)
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2022, ISO 10993-1:2018, IDT)
YY/T 0466.1 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (YY/T 0466.1-2023, ISO 15223-1:2021, MOD)
YY/T 0916 (All parts) Small-bore connectors for liquids and gases in healthcare applications [ISO 80369 (All parts)]
Notes: 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 0916.3-2022 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016, 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 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
ISO 8871-2 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
blocking
prevention of counterflow through the check valve (3.2)
3.2
check valve
valve that allows flow only in one direction
3.3
inline check valve
check valve (3.2) that is a built-in feature of the infusion set
3.4
flow rate
rate of flow through an open check valve (3.2) in the flow direction
Foreword i
Introduction iv
1 Scope
2 Normative references
3 Terms and definitions
4 Designation
5 Materials
6 Physical requirements
6.1 Particulate contamination
6.2 Leakage
6.3 YY/T 0916 (all parts) compatibility
6.4 Counterflow pressure resistance
6.5 Flow rate
6.6 Blocking performance
6.7 Opening pressure
6.8 Protective caps
7 Chemical requirements
8 Biological requirements
8.1 General
8.2 Sterility
8.3 Pyrogenicity
9 Labeling
9.1 General
9.2 Unit container
9.3 Label on shelf or multi-unit container
10 Packaging
11 Disposal
Annex A (Normative) Physical tests
A.1 General
A.2 Test for particulate contamination
A.3 Test for leakage
A.4 Test for pressure resistance in counterflow direction
A.5 Flow rate test
A.6 Test for blocking performance
A.7 Determination of opening pressure
Bibliography
