Extracorporeal systems for blood purification Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
YY 0267-2025 Extracorporeal systems for blood purification Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
1 Scope
This document specifies requirements for disposable extracorporeal blood and fluid circuits (hereinafter referred to as “extracorporeal blood and fluid circuits”) and accessories used in combination with blood purification therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration, and hemoconcentration; and this document also describes the corresponding test methods.
This document is applicable to disposable extracorporeal blood and fluid circuits and accessories used in combination with blood purification therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration, and hemoconcentration.
This document does not apply to:
—— hemodialyzers, hemodiafilters or hemofilters;
—— plasma separators;
—— haemoperfusion devices;
—— vascular access devices.
Note 1: Requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators are specified in YY 0053.
Note 2: Requirements for plasma separators are specified in YY 0465.
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.
GB/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682-2008, ISO 3696: 1987, MOD)
GB 9706.216-2021 Medical electrical equipment- Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16: 2018, MOD)
GB/T 13074 Blood purification terminology
GB/T 14233.1-2022 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB15811 Sterile hypodermic needles for single use (GB 15811-2016, ISO 7864: 1993, NEQ)
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)
GB/T 19335-2022 Blood flow products for single use - General specification
YY/T 0681.1 Test methods for sterile medical device package - Part 1: Test guide for accelerated aging
YY/T 0916.7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (YY/T 0916.7-2024, ISO 80369-7: 2021, IDT)
Pharmacopoeia of the People's Republic of China
3 Terms and Definitions
For the purposes of this document, the terms and definitions defined in GB/T 13074 apply.
4 Requirements
4.1 Biological evaluation
Parts of extracorporeal blood and fluid circuits that are intended to come into direct or indirect contact with blood shall be evaluated for freedom from biological hazards.
4.2 Sterility
Parts of extracorporeal blood and fluid circuits that are intended to come into direct or indirect contact with blood shall be sterile.
Note: Please refer to the single package of the product for the description about sterility (specific instructions for sterility of a product or non-whole-package product) and sterilization methods.
4.3 Endotoxin
The content of endotoxin in the parts of extracorporeal blood and fluid circuits that are intended to come into direct or indirect contact with blood shall not exceed 20 EU/set.
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
4.1 Biological evaluation
4.2 Sterility
4.3 Endotoxin
4.4 Mechanical property
4.5 Functional properties
4.6 Particle contamination
4.7 Chemical property
4.8 Expiration date
5 Test methods
5.1 Overview
5.2 Biological evaluation
5.3 Sterility
5.4 Endotoxin
5.5 Mechanical property
5.6 Functional properties
5.7 Particle contamination
5.8 Chemical property
5.9 Expiration date
Annex A (Informative) Technical differences between this document and ISO 8637-2: 2024 and their justifications
