The document summarizes the key changes between ISO 15223-1:2016 and ISO 15223-1:2021 for medical device symbol standards. There are several new symbols added, including for importer, distributor, model number, country of manufacturer, and symbols related to sterilization methods and presence of specific materials. The terms and definitions were also expanded. Normative references were updated to include newer editions of some standards.
The document summarizes the key changes between ISO 15223-1:2016 and ISO 15223-1:2021 for medical device symbol standards. There are several new symbols added, including for importer, distributor, model number, country of manufacturer, and symbols related to sterilization methods and presence of specific materials. The terms and definitions were also expanded. Normative references were updated to include newer editions of some standards.
Original Description:
Original Title
Gap Analysis Labels and Symbols ( ISO 15223-1) 2016 vs 2021
The document summarizes the key changes between ISO 15223-1:2016 and ISO 15223-1:2021 for medical device symbol standards. There are several new symbols added, including for importer, distributor, model number, country of manufacturer, and symbols related to sterilization methods and presence of specific materials. The terms and definitions were also expanded. Normative references were updated to include newer editions of some standards.
The document summarizes the key changes between ISO 15223-1:2016 and ISO 15223-1:2021 for medical device symbol standards. There are several new symbols added, including for importer, distributor, model number, country of manufacturer, and symbols related to sterilization methods and presence of specific materials. The terms and definitions were also expanded. Normative references were updated to include newer editions of some standards.
The document outlines changes made between the 2016 and 2021 versions of ISO 15223-1, including new symbols and updated references.
New terms and definitions were added, and several new symbols were included related to things like importers, distributors, and sterilization methods.
Twelve new symbols were added related to topics like importers, distributors, unique device identification, patient information, and material contents.
Gap Analysis ISO 15223-1 (2016 Vs 2021)
EN ISO 15223-1:2016 EN ISO 15223-1:2021 CHANGES COMMENT
Scope Scope This document identifies requirements This document identifies requirements for for symbols used in medical device symbols used in medical device labelling that labelling that convey information on the convey information on the safe and effective safe and effective use of medical use of medical devices. It also lists symbols devices. It also lists symbols that satisfy that satisfy the requirements of this the requirements of this document. document. This document is applicable to symbols used in a broad spectrum of medical This document is applicable to symbols used Same devices, which are marketed globally in a broad spectrum of medical devices, and therefore need to meet different which are marketed globally and therefore regulatory requirements. need to meet different regulatory These symbols may be used on the requirements. medical device itself, on its packaging or in the associated These symbols are marked on the medical documentation. device itself, placed on its packaging or The requirements of this placed in the associated accompanying document are not intended to apply to information. The requirements of this symbols specified in document are not intended to apply to other standards. symbols specified in other standards. Normative References Normative References ISO 70001), Graphical symbols for use ISO 7000 (database), Graphical symbols for on equipment — Registered symbols use on equipment — Registered symbols ISO 7001:2019, Graphical symbols — Public According to new ISO 8601, Data elements and information symbols references, …… interchange formats — Information ISO 8601-1:2019, Date and time — interchange — Representation of Representations for information interchange dates and times — Part 1: Basic rules ISO 8601-2:2019, Date and time — Representations for information interchange — Part 2: Extensions Gap Analysis ISO 15223-1 (2016 Vs 2021) ISO 15223-2, Medical devices — ISO 14971:2019, Medical devices -- Application of Symbols to be used with medical risk management to medical devices device labels, labelling, and ISO 13485:2016, Medical devices – Quality information management systems – Requirements for to be supplied — Part 2: Symbol regulatory purposes development, selection and validation ISO 15223-2:2010, Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation ISO 20417 1, Medical Devices - Information to be supplied by the manufacturer IEC 60417 (database), Graphical symbols for use on equipment IEC 80416-1:2008, Basic principles for graphical symbols for use on equipment — Part 1: Creation of graphical symbols for registration Terms and definitions Terms and definitions New terms and definitions will examine 3.1 to 3.6 3.1 to 3.22 and if we need a change, they will use in procedure.
ISO 15223-1:2016 Table 1 — Symbols to
ISO 15223-1:2021 Table 1 — Symbols to convey convey information essential for proper use information essential for proper use 5.1.1 5.1.1 Same 5.1.2 5.1.2 Same 5.1.3 5.1.3 Same 5.1.4 5.1.4 Same 5.1.5 5.1.5 Same 5.1.6 5.1.6 Same Gap Analysis ISO 15223-1 (2016 Vs 2021) 5.1.7 5.1.7 Same 5.1.8 - Importer New Symbol New Symbol 5.1.9 - Distributor N/A 5.1.10 – Model Number New Symbol New Symbol 5.1.11 - Country of manufacturer 5.2.1 5.2.1 Same 5.2.2 5.2.2 Same 5.2.3 5.2.3 Same 5.2.4 5.2.4 Same 5.2.5 5.2.5 Same 5.2.6 5.2.6 Same 5.2.7 5.2.7 Same 5.2.8 5.2.8 Same 5.2.9 5.2.9 Same 5.2.10 - Sterilized using vaporized New Symbol hydrogen peroxide 5.2.11 - Single sterile barrier New Symbol system N/A 5.2.12 - Double sterile barrier New Symbol system 5.2.13 - Single sterile barrier system New Symbol with protective packaging inside 5.2.14 - Single sterile barrier New Symbol system with protective packaging outside 5.3.1 5.3.1 Same 5.3.2 5.3.2 Same 5.3.3 5.3.3 Same Gap Analysis ISO 15223-1 (2016 Vs 2021) 5.3.4 5.3.4 Same 5.3.5 5.3.5 Same 5.3.6 5.3.6 Same 5.3.7 5.3.7 Same 5.3.8 5.3.8 Same 5.3.9 5.3.9 Same 5.4.1 5.4.1 Same 5.4.2 5.4.2 Same 5.4.3 5.4.3 Same 5.4.4 5.4.4 Same 5.4.5 5.4.5 Same 5.4.6 – Contains human blood or plasma New Symbol derivatives
5.4.7 - Contains a medicinal New Symbol
substance 5.4.8 - Contains biological material of New Symbol animal origin N/A 5.4.9 - Contains biological material of New Symbol human origin
5.4.10 - Contains hazardous substances New Symbol
5.4.11 - Contains nano materials New Symbol
5.4.12 - Single patient multiple use New Symbol
N/A Our products are
5.5 IVD-specific 5.5 IVD-specific medical device. 5.6.1 5.6.1 Same Gap Analysis ISO 15223-1 (2016 Vs 2021) 5.6.2 5.6.2 Same 5.6.3 5.6.3 Same 5.6.4 5.6.4 Same 5.6.5 5.6.5 Same 5.6.6 5.6.6 Same 5.7.1 5.7.1 Same