ISO 3826-2-2008 PDF

Full title and description

Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets. This part of ISO 3826 specifies a set of internationally-recognized graphical symbols and their meanings for use on blood collection and storage medical devices, labels and accompanying documentation to reduce language-related labelling complexity and improve safety in the blood supply chain.

Abstract

ISO 3826-2:2008 addresses graphical symbols that may be used to convey specific items of information related to medical devices dedicated to blood collection, processing and storage. The symbols are intended to help manufacturers market identical products in countries with different language requirements, to simplify labelling and reduce confusion or delay in locating appropriate language-specific instructions. The symbols do not replace national regulatory requirements; they provide precisely defined meanings to support international labelling practice.

General information

• Status: Published (International Standard; under review/revision stage indicated by ISO lifecycle).
• Publication date: 2008-08 (Edition 1, 2008).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 01.080.20; 11.040.20 (graphical symbols; transfusion/infusion/injection equipment).
• Edition / version: Edition 1 (2008).
• Number of pages: 11 (ISO published document page count).

Scope

This part of ISO 3826 specifies graphical symbols and definitions intended for use on plastics collapsible containers (blood bags) and related labels and instruction leaflets used in blood collection, storage, processing and distribution. It covers symbols to indicate handling, contents, intended use, safety features and other information where multi-language labelling would otherwise be required; it is intended for the medical device (container) rather than the therapeutic product and does not override national regulatory text requirements.

Key topics and requirements

• Definition and specification of standardized graphical symbols for blood collection and storage containers (labels and instruction leaflets).
• Guidance on intended placement and use of symbols on devices, labels and accompanying documentation.
• Clarification that symbols are supplementary to — not replacements for — mandatory national/regulatory textual requirements.
• Support for manufacturers to reduce multi-language label variants and for blood centres/distributors to simplify and secure operating procedures.
• Coordinate usage with other parts of ISO 3826 (requirements for containers and integrated features) where relevant.

Typical use and users

Primary users are manufacturers of plastics collapsible containers (blood bags) and their labelling/design teams, regulatory and quality personnel, distributors of blood collection devices, and blood centres and transfusion services that handle, store and distribute blood and blood components. The standard is also used by procurement and compliance teams that need harmonized labelling across multiple language markets.

Related standards

ISO 3826 is a multipart series; relevant related parts include: ISO 3826-1 (requirements for conventional plastics collapsible containers; latest consolidated/revised edition published as ISO 3826-1:2019). ISO 3826-3 (blood bag systems with integrated features; original 2006 edition, under revision / DIS development). ISO 3826-4 (aphaeresis blood bag systems with integrated features; published 2015, under revision processes).

Keywords

blood bag, plastics collapsible container, blood components, graphical symbols, labelling, instruction leaflet, transfusion equipment, ISO 3826-2.

FAQ

Q: What is this standard?

A: ISO 3826-2:2008 is the International Standard that specifies graphical symbols for use on labels and instruction leaflets for plastics collapsible containers used with human blood and blood components.

Q: What does it cover?

A: It defines a set of internationally-recognized symbols and their meanings to convey information about handling, contents, safety features and use of blood collection/storage devices, helping reduce multi-language labelling complexity. The symbols are supplementary to national regulatory text requirements.

Q: Who typically uses it?

A: Manufacturers of blood collection containers and devices, labelling and regulatory teams, distributors, blood centres/transfusion services, and procurement/compliance personnel working across multiple language markets.

Q: Is it current or superseded?

A: ISO 3826-2:2008 remains the published edition; ISO records show the publication was last reviewed and confirmed in 2022, and the standard is indicated for revision with a Draft International Standard (ISO/DIS 3826-2) shown as under development. Users should check national adoption status and any newer DIS/edition publications before assuming the text is final.

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 3826 series (Plastics collapsible containers for human blood and blood components). Other parts include Part 1 (requirements for conventional containers; latest ISO 3826-1:2019), Part 3 (blood bag systems with integrated features) and Part 4 (aphaeresis blood bag systems), all of which should be consulted where applicable.

Q: What are the key keywords?

A: blood bag, collapsible container, graphical symbols, labelling, blood collection, blood components, transfusion equipment, ISO 3826-2.