ISO 3826-2:2008
Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets
Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 11
- Дата публикации:
- 29 июля 2008 г.
- Издание:
- ISO IS 3826 edition 1 version 1
- ICS:
- 01.080.20
ISO 3826-2:2008 addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users. The symbols specified in ISO 3826-2:2008 do not replace current national regulatory requirements. Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation. As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. ISO 3826-2:2008 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings. ISO 3826-2:2008 is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling. ISO 3826-2:2008 may also be of assistance to different stages of the blood supply chain, e.g.: distributors of blood collection devices (manual or automated) or other representatives of manufacturers; blood centres and distribution centres to simplify and secure the operating procedures. The use of these symbols is primarily intended for the medical device rather than the therapeutic product.
Abstract
Overview
ISO 3826-2:2008 - "Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets" defines a system of internationally recognized graphical symbols for blood collection, processing and storage medical devices. The standard helps manufacturers and users reduce multi-language labelling, improve safety and speed in critical situations, and rationalize logistics when marketing identical products across countries.
Key topics and technical requirements
- Scope and intent: Symbols convey essential information on the device, label or instruction leaflet for blood and blood component containers without replacing national regulatory text requirements.
- System of symbols: A structured set of basic symbols (e.g., whole blood, plasma, red blood cell concentrate, buffy coat, platelets, anticoagulant, leukocyte filter, apheresis protocols) that can be combined into compound symbols (e.g., plasma container, anticoagulant solution, leukocyte filtration process).
- Design and reproduction: Graphical representations must follow the specified forms (line thickness, orientation, filled areas) as published in the standard tables and referenced symbol registries (ISO 7000 registration numbers are cited).
- Legibility requirements: Symbols and associated information shall be legible at a specified viewing illumination and distance appropriate to typical label sizes (standard references mention 215 lx as an illumination benchmark).
- Flexibility rules: Symbols may be reversed (white/black) to suit reproduction; the standard does not mandate symbol color or absolute size but designs are optimized for typical label spaces and on-line printing.
- Documentation: Annexes provide illustrative label examples and application guidance; normative cross-references include ISO 15223-1 for other medical-device symbols.
Practical applications
- Manufacturers: Reduce translation costs and label variants by using standardized symbols for devices marketed internationally (blood bags, solution containers, processing kits).
- Distributors and OEMs: Simplify inventory labelling and shipping cartons, making handling and identification faster and safer.
- Blood centres & transfusion services: Improve workflow clarity for collection, storage, processing and transfusion steps; reduce training time and misidentification risks.
- Regulatory and QA teams: Use symbol set to support compliance and to harmonize labelling across markets while ensuring national regulatory text requirements remain met.
Related standards
- ISO 15223-1 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied.
- ISO 7000 / IEC 60417 - Graphical symbol registries referenced for symbol registration and artwork.
Keywords: ISO 3826-2:2008, graphical symbols, blood containers, medical device labelling, blood collection, transfusion, label symbols, ISO 15223-1.
Технические детали
- Технический комитет
- ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
- SKU
- ISO 3826-2:2008
Похожие стандарты
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