ISO 3826 Plastic Foldable Containers for Human Blood and Blood Components.

The “ISO 3826 Plastic foldable containers for human blood and blood components” standard, published by the International Organization for Standardization (ISO), consists of the following sub-sections published under the same title:

• ISO 3826-1 Part 1: Conventional containers standard describes requirements, including performance requirements, for collapsible, ventless, sterile plastic containers with collection tube outlet ports, integrated needles, and optional transfer tubes, for the collection, storage, processing, transport, separation, and administration of blood and blood components. Plastic containers may contain anticoagulant or preservative solutions depending on the intended application.

This standard also applies to multiple plastic container units, such as double, triple, quadruple, or multi-unit units. Unless otherwise specified, all tests described in this standard apply to ready-to-use plastic containers. This standard does not apply to plastic containers with integrated filters.

In the critical field of transfusion medicine, the integrity of blood collection and storage systems is paramount. At the heart of this process lies a seemingly simple but tightly regulated component: the plastic collapsible containers used for human blood and blood components. The ISO 3826-1 standard is a global standard that sets benchmarks for quality, safety, and performance in these essential medical devices.

The ISO 3826-1 standard ensures that these containers meet stringent requirements for preventing contamination, maintaining sterility, and withstanding collection, storage, transport, and handling requirements.

• ISO 3826-2 Part 2: Graphic symbols for use on labels and instructors addresses symbols that may be used to convey specific information relating to medical devices for blood collection and storage. This information may be presented on the device itself, as part of a label, or with the device. The symbols specified in this standard do not replace existing national regulatory requirements.

Manufacturers attempt to reduce labeling costs by minimizing or rationalizing variations. This leads to significant translation, design, and logistics challenges when multiple languages ​​are included on a single label or document. Like other medical devices, blood therapy devices labeled in different languages ​​can experience confusion and delays in finding the appropriate language.

This standard proposes solutions to these problems through the use of internationally recognized and precisely defined symbols. It is primarily designed for use by medical device manufacturers dedicated to blood collection, processing, storage, and distribution, who market the same products in countries with differing language requirements for medical device labeling.

The ISO 3826-2 standard applies to disposable plastic collapsible containers and related devices for blood and blood components, and covers all medical equipment requiring clear and universal labeling in the transfusion chain. Its primary aim is to facilitate cost-effective and multilingual compliance by replacing detailed text with symbols. This standard includes:

• Symbol features: Includes a carefully selected set of graphic symbols with precise meanings. These are designed to provide clarity and avoid ambiguity, and are suitable for reproduction on small labels.
• Application guidelines: Symbols may appear on the device, labels, or in the user manual. Generally, their comprehensibility by the user must be verified through usability testing, and they do not replace, but supplement, national regulations.
• Design principles: Emphasizes readability and scalable symbols, high contrast, and adaptability to color or black and white printing. This standard recommends practices from the ISO 15223-1 standard for medical device symbols, while excluding requirements regarding symbol sizes.
• Testing and verification: Manufacturers must ensure that symbols conform to standard definitions and, where appropriate, reference ISO 3864 for safety colours and ISO 7000 for public information symbols.

Compliance includes third-party audits and ensures that symbols reinforce, rather than replace, textual warnings in critical situations. This standard does not cover ventilated or apheresis-specific systems, but it supports their labeling needs.

• The standard “ISO 3826-3 Part 3: Blood bag systems with integrated features” describes the requirements, including performance requirements, for integrated features on plastic, collapsible, non-ventilated, sterile containers (blood bag systems). Blood bag systems are not required to include all integrated features specified in this standard. Integrated features include:
• Leukocyte filter
• Pre-donation sampling device
• Upper and lower bags
• Platelet storage bag
• Needle stick injury protection device.

In addition to the ISO 3826-1 standard, which specifies the requirements for conventional containers, this standard includes additional requirements for blood bag systems using multiple units. This standard does not cover automated blood collection systems. Unless otherwise specified, all tests described in this standard apply to ready-to-use plastic containers. Where appropriate, chemical, physical, and biological tests conforming to the ISO 3826-1 standard are used.

The ISO 3826-3 standard targets plastic, foldable, non-ventilated, sterile blood bag systems equipped with one or more integrated features that support advanced processes, going beyond basic containers. All testing is performed on readily available systems, incorporating chemical, physical, and biological assessments from the ISO 3826-1 standard where applicable. Key elements include:

• Integrated features:
• Leukocyte filter: It should minimize transfusion reactions by reducing white blood cells to below 5 x 10^6 per unit, while maintaining flow rates and hemolysis limits.
• Pre-donation sample collection device: Enables the use of sterile directional bags for testing without compromising the main collection volume.
• Upper and lower bags: Facilitate efficient red blood cell retrieval during the procedure and have ports at both ends for optimal drainage.
• Platelet storage bag: Designed for shaking and gas exchange, it guarantees the viability of platelets for 5-7 days.
• Needle stick protection device: Includes safety mechanisms to prevent percutaneous injuries during installation or disposal.
• Performance criteria:
• Sterility and biocompatibility: Verification against microbial entry and endotoxin limits according to ISO 10993 standard series.
• Physical durability: Resistance to centrifugation, pressure testing, and leak detection in multi-unit setups.
• Compatibility: Compatible with anticoagulants and additives; does not contain extractable substances that affect blood components.
• Dimensional and functional characteristics: Volume tolerances, sealing integrity, and flow dynamics for safe application.

This standard mandates third-party conformity assessment, ensuring systems meet global regulatory thresholds such as those of the FDA or WHO. It does not specify manufacturing processes but focuses on the safety of the final product.

• The standard “ISO 3826-4 Part 4: Apheresis blood bag systems with integrated features” describes the requirements, including performance requirements, for apheresis blood bag systems with integrated features. Apheresis blood bag systems are not required to include all the integrated features defined in this standard. Integrated features refer to the following:
• Needle stick injury protection device
• Leukocyte filter
• Sterile barrier filter
• Pre-collection sampling device
• Red blood cell storage bag
• Plasma storage bag
• Platelet storage bag
• Polymorphonucleic (e.g., stem) cell storage bag
• Post-collection sampling devices
• Connections for storage solutions, anticoagulant, and replacement fluid.

This standard specifies additional requirements for blood bag systems used to collect varying amounts of blood components or cells via apheresis. This standard can be used in automated or semi-automated blood collection systems. In some countries, national pharmacopoeias or other national regulations are legally binding and take precedence over this standard.

The ISO 3826-4 standard focuses on non-ventilated, sterile, plastic, foldable blood bag systems designed for apheresis, where blood is processed extracorporeally to isolate its components. It applies to systems that collect varying amounts of plasma and are tested in ready-to-use configurations. The key elements are as follows:

• Integrated features:
• Leukocyte and sterile barrier filters: Reduce contaminants to prevent reactions; must filter out more than 99,99% of leukocytes.
• Sampling equipment: Pre- and post-collection bags for microbial testing without compromising sterility.
• Storage bags: Manufactured with gas-permeable materials for viability, they are specifically designed for red blood cells, plasma, platelets, or polymorphonuclear (e.g., stem) cells.
• Safety mechanisms: Protection against needle stick injury and secure connections for anticoagulants, replacement fluids, or storage solutions.
• Connections and ports: Multiple port designs for seamless integration with apheresis machines.
• Performance criteria:
• Sterility and biocompatibility: Endotoxin limits comply with ISO 10993 standard biological evaluations.
• Physical integrity: Withstands pressures up to 500 mmHg, centrifugation at 3.000 g, and leak tests in multi-bag systems.
• Functional features: Minimum flow rates of 100 ml/min, plus/minus 5% volume accuracy, and resistance to bending during prolonged operation (up to 4 hours).
• Chemical compatibility: Does not leak when used with citrate-based anticoagulants or additives.

In short, the ISO 3826 standard is considered important for the following reasons:

• It ensures patient safety.
• It ensures product standardization.
• It provides quality control and traceability.
• Ensures international trade and regulatory compliance.
• It simplifies blood banking processes.

For many years, our organization, with its competent and experienced staff, has been understanding the needs of its clients, providing the advanced testing services they require, and assisting in the establishment, implementation, and improvement of management systems. Within this framework, we also provide testing services to businesses in accordance with the "ISO 3826 Plastic foldable containers for human blood and blood components" standard.