ISO 1135 Medical Transfusion Equipment

The “ISO 1135 Medical transfusion equipment” standard, published by the International Organization for Standardization (ISO), consists of the following sub-sections published under the same title:

• The standard “ISO 1135-1 Part 1: Glass transfusion bottles, caps and stopcocks” describes the dimensions and requirements for transfusion bottles for medical use to ensure that the equipment is functionally interchangeable. The secondary objectives of this standard are:
• Characteristics relating to the quality and performance of materials used in transfusion equipment.
• A unified presentation of terms and definitions for this type of equipment.

Transfusion bottles with rubber caps should, under normal conditions of use, not contain substances that have undesirable effects on the contents or cause harmful effects on the patient receiving the contents. A test to evaluate these effects has not yet been developed, and therefore no additional requirements have been added.

This standard specifies the requirements for single-use sterile glass transfusion vials.

The International Organization for Standardization (ISO) develops and publishes international standards to ensure quality, safety, and efficiency across various sectors. In the field of medical devices, standards play a critical role in protecting patient health by defining requirements for equipment used in procedures such as blood transfusions. The ISO 1135-1 standard is a significant standard focusing on transfusion equipment for medical use. This standard specifically addresses glass transfusion vials, caps, and closures, ensuring they meet stringent criteria for compliance and performance. This standard has been effective in standardizing the components necessary for safe blood administration.

The main objectives of the ISO 1135-1 standard are as follows:

• Dimension standardization: Defining precise dimensions for bottle necks, volumes (typically 250 ml to 500 ml), and cap interfaces to prevent leaks or discrepancies.
• Material quality: Providing guidelines on the composition of glass (e.g., borosilicate for chemical resistance) and elastomeric caps that are resistant to sterilization processes such as autoclaving.
• Safety and compatibility: Minimizing the risks of contamination or hemolysis by ensuring that components do not adversely interact with blood or blood components.

This standard excludes alternatives to glass and focuses solely on tempered glass containers, which are preferred due to their ineffectiveness in preserving blood integrity.

In transfusion medicine, precision is paramount to prevent complications such as air embolism, infection, or dosage errors. This standard has contributed to this by promoting uniformity, facilitating global trade in medical supplies and reducing the training burden on healthcare providers. For example, standardized vials have improved response times in trauma care by enabling rapid changeover in emergencies.

• The standard “ISO 1135-3 Part 3: Disposable blood collection sets” describes the requirements for types of medical blood collection sets to ensure functional interchangeability of transfusion equipment. This standard applies only to disposable sterile blood collection sets. This standard also aims to ensure the following:
• Characteristics relating to the quality and performance of materials used in transfusion equipment.
• A unified presentation of terminology for this equipment.

In some countries, national pharmacopoeias or other national regulations are legally binding and take precedence over this standard.

The ISO 1135-3 standard specifically regulates blood collection sets (special tubing and needle assemblies used to collect blood from donors into collection containers). This standard addresses the increasing complexity of blood collection systems, including anticoagulation, filtration, and multiple bag configurations. This standard applies to disposable, sterile blood collection sets designed for collecting whole blood or blood components from human donors. This standard covers:

• Needle and tube assemblies
• Anticoagulant or preservative solutions
• Primary collection bags and satellite bags
• In-line filters and sampling devices

The main objectives of this standard include:

• Functional interchangeability: Ensuring reliable connection of sets from different manufacturers to collection containers and processing equipment.
• Donor safety: Thanks to needle design and protective features, pain, hematoma risk, and needle stick injuries are minimized.
• Blood quality: To prevent hemolysis, clotting, or bacterial contamination during phlebotomy and storage.
• System closure: Ensuring a completely closed and sterile pathway from the intravenous line to the storage bag.

This standard does not cover apheresis devices and reusable equipment.

Performance tests include the following:

• Flow rate: 40-80 mL/min (500 mL blood bag, 1 m height, 37 degrees).
• Air removal: No air passage after priming with 50 mL of saline.
• Filter efficiency: Removal of more than 80% of 20-40 µm particles.
• Leak test: No leaks at 300 mmHg pressure.
• Drop size: 0,05 mL plus/minus 10 percent (20 drops = 1 mL).
• Priming volume: Maximum 30 mL (adult set).
• The standard “ISO 1135-4 Part 4: Disposable transfusion sets, gravity feeding” describes the requirements for disposable transfusion gravity sets for medical use to ensure compatibility with blood and blood component containers and intravenous equipment. The secondary objectives of this standard are as follows:
• To provide guidance on specifications regarding the quality and performance of materials used in transfusion sets.
• To provide descriptions for transfusion set components.
• To ensure the kits are compatible with various cellular and plasma blood components.

In some countries, national pharmacopoeias or other national regulations are legally binding and take precedence over this standard.

The ISO 1135-4 standard applies to disposable, sterile transfusion sets designed for gravity-fed applications:

• Whole blood
• red blood cells
• Plazma
• Platelets
• Cryoprecipitate

This standard excludes the following:

• Pressurized infusion sets (covered by ISO 1135-5 standard)
• Apheresis application sets
• Pediatric micro-drip kits

The primary objectives of this standard are:

• Patient safety: Preventing air embolism, particulate contamination, and hemolysis.
• Functional interchangeability: Ensuring compatibility with blood bags, needles, and IV catheters.
• Reliability: Maintaining flow accuracy and structural integrity in clinical use.
• Regulatory compliance: Supporting compliance with FDA, EMA, and WHO standards.

Performance tests include the following:

• Flow rate: 40-80 mL/min (500 mL blood bag, 1 m height, 37 degrees).
• Air removal: No air passage after priming with 50 mL of saline.
• Filter efficiency: Removal of more than 80% of 20-40 µm particles.
• Leak test: No leaks at 300 mmHg pressure.
• Drop size: 0,05 mL plus or minus 10 percent (20 drops = 1 mL)
• Priming volume: Maximum 30 mL (adult set).
• The standard “ISO 1135-5 Part 5: Disposable transfusion sets with pressurized infusion apparatus” describes the requirements for disposable transfusion sets used with pressurized infusion equipment capable of generating pressures up to 200 kPa (2 bar). This standard guarantees compatibility with blood and blood component containers as well as intravenous equipment. The secondary objectives of this standard are:
• To provide guidance on specifications regarding the quality and performance of materials used in transfusion sets.
• To provide descriptions for transfusion set components.
• To ensure the kits are compatible with red blood cell and plasma blood components.

Platelet components should not be transfused under pressure using these sets.

In some countries, national pharmacopoeias or other national regulations are legally binding and take precedence over this standard.

The main objectives of this standard are:

• Fast and safe delivery: Facilitates flow rates that overcome gravity systems while preventing hemolysis or air embolism.
• Interchangeability: Provides seamless integration with blood bags (ISO 3826), gravity sets (ISO 1135-4), and IV catheters.
• Material integrity: Specifies phthalate limits and performance under pressure to minimize toxicity and equipment failure.
• Quality assurance: Provides guidance on component identification and clinical safety testing.

This standard supports both manual blood pressure bags and automatic pumps, and prioritizes compatibility with whole blood and components.

Performance tests include the following:

• Flow rate under pressure: at least 200 mL/min at 100 kPa (whole blood, 37 degrees).
• Hemolysis: Maximum 1% free hemoglobin after a 500 mL infusion.
• Air removal: Maximum air passage of 0,25 mL at maximum pressure.
• Explosion/leakage: No malfunction for 15 minutes at 300 kPa.
• Filter retention: At least 80 percent residue capture (simulated clots).
• Priming volume: Maximum 25 mL, no residue after washing.

These ensure that the sets maintain blood integrity during high-speed transport.

According to the ISO 1135-5 standard, pressurized infusion sets are indispensable in large-scale transfusion protocols where patients rapidly lose more than 10 units of blood (commonly seen in trauma, childbirth, and cardiac surgery).

Clinically, they minimize hypovolemic shock by reducing transfusion times from hours to minutes. Standardized designs reduce errors in high-stress environments, while filters trap microembolisms, reducing pulmonary risks. In the global health context, they support resource-constrained environments with manual pressure cuffs in accordance with WHO emergency guidelines.

For many years, our organization, with its competent and experienced staff, has been understanding the needs of its customers, providing the advanced testing services they require, and assisting them in the establishment, implementation, and improvement of management systems. Within this framework, we also provide testing services to businesses in accordance with the "ISO 1135 Medical transfusion equipment" standard.