Overview
ISO 3826-1:2019/Amd 1:2023 is the latest amendment to the international standard governing plastics collapsible containers used for human blood and blood components. Published by the International Organization for Standardization (ISO), this update focuses specifically on Part 1 of the standard which addresses conventional plastic containers. These containers are essential for the safe storage, transport, and processing of blood and blood-derived products in medical and pharmaceutical applications.
The amendment enhances the original 2019 standard by specifying additional requirements related to freezing and ionizing irradiation processes to ensure container integrity and safety under these critical conditions.
Key Topics
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Container Use for Freezing
The amendment establishes clear instructions for the use of plastics containers in freezing applications, primarily for plasma storage. It mandates that the container, filled halfway with water, must withstand slow freezing to −80 °C for 24 hours, followed by thawing at 37 °C, and finally stabilizing at room temperature. These containers must comply with specified ISO test requirements after freezing cycles to ensure durability and performance.
- Validation guidelines for containers subjected to shock or blast freezing are also specified.
- Protective measures are outlined if refrigerant solutions are used, such as enclosing the container in a protective bag to prevent direct contact.
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Container Use for Ionizing Irradiation
For containers intended to store irradiated blood components, the amendment requires containers to withstand a maximum dose of 50 Gray irradiation without compromising integrity. Testing must be performed using validated equipment, ensuring that post-irradiation testing for leaks, strength, and other physical properties is met.
- The volume filled during irradiation testing is limited to 350 ml to standardize testing procedures.
- Validation for irradiation use is emphasized as essential prior to implementation.
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Regulatory Alignment
The amendment stresses users’ responsibility to be aware of additional regulatory requirements from authorities such as the European Directorate for the Quality of Medicines (EDQM), harmonizing the standard with international quality assurance frameworks for blood components.
Applications
ISO 3826-1:2019/Amd 1:2023 is critical for manufacturers, healthcare providers, and blood banks involved in the collection, storage, and transfusion of human blood and blood components. Key applications include:
- Blood Transfusion Services
Ensuring containers meet freezing and irradiation resistance standards preserves blood safety and viability.
- Pharmaceutical Manufacturing
Compliance with sterilization and irradiation standards supports aseptic processing of blood-derived drugs.
- Research and Clinical Laboratories
Enables reliable sample storage under rigorous temperature and radiation exposure conditions.
- Quality Assurance Programs
Adherence to standardized testing protocols minimizes risks of container failure during transport or storage.
Related Standards
This amendment complements other parts of the ISO 3826 series dedicated to plastics collapsible containers for blood, including:
- ISO 3826-2: for containers with integral tubing
- ISO 3826-3: for top-and-side entry bags
- ISO 3696: for water purity used in testing
- ISO/IEC Directives Part 1 and Part 2: guidelines on development and maintenance of standards
Additionally, the standard aligns with regulations and guides on blood component preparation and quality assurance, such as the EDQM Guide to the Preparation, Use and Quality Assurance of Blood Components.
The 2023 Amendment 1 to ISO 3826-1 strengthens the standard’s practical value in safeguarding blood storage containers during freezing and irradiation, promoting consistent global quality and patient safety in transfusion medicine. For the latest information and purchasing options, visit the ISO website.
Open preview (PDF)Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers — Amendment 1