Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018
1Key Takeaways
This International Standard specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This standard is…
2Expert Interpretation
This comprehensive analysis of the EN ISO 8637-2:2018 international standard for blood purification extracorporeal circulation systems covers technical specifications, safety requirements, test methods, and EU Medical Device Directive compliance guidance, providing professional guidance for medical device manufacturers and clinical users.
EN ISO 8637-2:2018 Standard Overview and Technical Evolution
EN ISO 8637-2:2018, "Extracorporeal blood purification systems — Part 2: Extracorporeal blood circuits for hemodialyzers, hemodiafilters, and hemofilters," is a key international standard that replaces DIN EN ISO 8638:2014-03. This standard was jointly developed by ISO/TC 150, Technical Committee on Surgical Implants, and CEN/TC 205, Technical Committee on Non-viable Medical Devices, and was officially released and implemented in August 2018.
Scope of Application and Key Technical Requirements
This standard applies to single-use extracorporeal blood circuits specifically designed for use with hemodialyzers, hemodiafilters, and hemofilters. The standard specifies the technical requirements needed to ensure safety and satisfactory functionality, but considering practical feasibility, it does not make specific provisions for structural materials. It only requires that the materials be tested and the relevant procedures and results be provided as required.
| Component type | Technical requirements | Test method | Conformity verification |
|---|---|---|---|
| Blood contact parts | Biological safety assessment | ISO 10993 series | Risk management document review |
| Connector size | Compliant with ISO 80369-7 | Dimensional inspection | Visual inspection |
| Pressure tolerance | 1.5 times the maximum recommended pressure | Hydrostatic pressure test | Leak check |
| Sterility requirements | Sterility of liquid contact surfaces | Sterilization validation | Process record review |
Key technological innovations and improvements
Compared with the previous version of the standard ISO 8638:2010, this version has undergone important technical revisions:
Connector compatibility optimization: To ensure compatibility with hemodialyzers, hemodiafilters and hemofilters specified in ISO 8637-1, the connector dimensions have been re-standardized and detailed. The connector design and size selection are designed to minimize the risk of blood leakage or air ingress, allowing the use of connectors with fixed or removable locking sleeves.
Improved Safety: It specifies that arterial patient connections must be marked red, and venous patient connections must be marked blue. The markings must be clearly visible within 100mm of the tubing end. This requirement significantly improves clinical safety and operational convenience.
Biosafety Requirements and Testing Specifications
According to Sections 4.1-4.3 of the standard, all device components intended for direct or indirect contact with patient blood must undergo a biosafety assessment:
Sterility Requirements: All fluid-contacting surfaces of the device and all connector mating surfaces must be sterile. Compliance must be verified through validated sterilization procedure records.
Pyrogen-Free Requirements: Blood-conducting components of the device must be pyrogen-free. Compliance must be verified in accordance with ISO 10993-11. Biocompatibility: Each new device type must undergo a biosafety assessment in accordance with ISO 10993-1, ISO 10993-4, or ISO 10993-7 (as applicable), particularly if any changes are made to the device's materials of manufacture or sterilization procedures. Section 4.4.1 of the standard specifies the pressure tolerance requirements for devices: the device must be able to withstand an overpressure of 1.5 times the manufacturer's recommended maximum pressure and a negative pressure not exceeding 700 mmHg (93.3 kPa below atmospheric pressure), or the highest negative pressure achievable at high altitude. The test method includes two options: a water pressure test or an underwater bubble test, with the test duration maintained for at least 10 minutes and the temperature controlled at (37 ± 1)°C. This requirement ensures the device's reliability and safety during clinical use. The standard provides detailed requirements for different types of connectors: Vascular access device connectors: Unless the extracorporeal blood circulation circuit and vascular access device are designed as an integrated system, the connector used to connect the vascular access device must be a male, lockable, tapered connector with a 6% (Luer) taper. Auxiliary component connectors: All extracorporeal blood circulation circuit components used for non-integrated auxiliary components (such as heparin tubing, pressure transmission tubing, drug delivery tubing, and volume adjustment tubing) must be equipped with a terminal device that meets the performance requirements of ISO 80369-7. Risk Management and EU Directive Conformity: This standard supports the essential requirements of EU Directive 93/42/EEC on medical devices. Annex ZA provides detailed compliance guidance, clarifying the correspondence between the various clauses of the standard and the essential requirements of the EU directive.
Risk management requirements: When a risk management process is referenced in the standard, the process must comply with Directive 93/42/EEC as amended by Directive 2007/47/EC. This means that risks must be reduced "to the greatest extent possible", "minimized" or "eliminated/eliminated" according to the wording of the corresponding essential requirements.
| EU Directive requirements | Standard clauses | Conformity statement |
|---|---|---|
| Basic requirement 7.1 | 4.1,4.2,4.3,5.2,5.3,5.4 | Full coverage of biosafety requirements |
| Basic requirement 7.2 | 4.1,4.2,4.3,5.2,5.3,5.4 | Cover biosafety, sterility respectively Labeling and Labeling RequirementsChapter 6 of the standard specifies detailed device labeling requirements:Individual Container Labeling: Must include important information such as the manufacturer's name and address, device trade name, manufacturer identification code, batch or serial number, expiration date, sterilization method, single-use indication (if applicable), and declaration of sterility and pyrogen-free. External Container Labeling: Must display manufacturer information, device description and quantity, batch identification, declaration of sterility, handling and storage instructions, and expiration date. Instructions for Use: Detailed instructions for use must be provided, including maximum pressure limits, compatibility information, preparation instructions, explanation of color coding, and instructions for use of sensor guards.
Implementation recommendations and clinical application guidanceManufacturer implementation recommendations: When designing and producing extracorporeal blood circulation circuits, medical device manufacturers should establish a comprehensive quality management system (ISO 13485 compliance is recommended) to ensure quality control throughout the entire process, from raw material procurement to final product. Particular attention should be paid to key links such as biocompatibility assessment, sterilization process validation, and stability studies. Recommendations for use in medical institutions: During clinical use, the manufacturer's instructions should be strictly followed, with particular attention to the correct use of connectors, calibration of pressure monitoring equipment, and correct configuration of air detectors. Medical staff should receive regular standard training to ensure that they understand and comply with relevant safety requirements. Regulatory compliance recommendations: For products entering the EU market, manufacturers need to ensure compliance with the Medical Device Regulation (MDR) and establish complete technical documentation, including risk analysis, clinical evaluation, and post-market surveillance plans. Standard Development Trends and Future OutlookWith the continuous development of blood purification technology, the standards for extracorporeal blood circulation circuits will continue to evolve. Possible future development directions include: safety assessment of new material applications, integration of digital monitoring technologies, and environmental considerations for disposable devices. Relevant stakeholders are advised to continue to pay attention to the work of ISO/TC 150/SC 4 Cardiovascular Implants and Extracorporeal Systems Technical Committee to keep abreast of standard updates. The implementation of this standard will help improve the safety and effectiveness of blood purification treatments, provide patients with more reliable medical protection, and promote the standardized development of the medical device industry. 3Version History5Citation Network0
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Referenced herein
Referenced by DIN EN ISO 8637-2:2018
DIN EN ISO 10993-11:2018
DIN EN ISO 10993-1:2010
DIN EN ISO 10993-4:2017
DIN EN ISO 10993-7:2009
DIN EN ISO 11135:2014
DIN EN ISO 11137-1:2015
DIN EN ISO 11137-2:2015
DIN EN ISO 11137-3:2017
6Frequently Asked QuestionsWhat is DIN EN ISO 8637-2:2018?
DIN EN ISO 8637-2:2018 — Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018); German version EN ISO 8637-2:2018 is an international standard developed by German Institute for Standardization. This International Standard specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors...
What does DIN EN ISO 8637-2:2018 cover?
This standard covers: This International Standard specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of DIN EN ISO 8637-2:2018?
The current published version is DIN EN ISO 8637-2:2018, published on 2018-12-00. Always check for amendments or pending revisions.
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