February 10, 2022 EU MDR
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ISO 15223 Labeling New Version Changes

ISO 15223-1 Gap Analysis

EN ISO 15223-1:2016 EN ISO 15223-1:2021 Changes
Scope Scope Same
Normative References
ISO 70001
ISO 8601
ISO 15223-2
IEC 80416-1:2008
Normative References
ISO 7000
ISO 7001:2019
ISO 8601-1:2019
ISO 8601-2:2019
ISO 14971:2019 (Clause 3.9, 3.18- new)
ISO 13485:2016 (Clause 3.11 new)
ISO 15223-2:2010
ISO 20417 (Clause 3.2, 3.3, 3.5, 3.8, 3.10, 3.11, 3.15, 3.16, 3.17, 3.22, 3.25, 3.26, 3.28- new; 3.12, 3.29- modified)
IEC 60417
IEC 80416-1:2008 (Clause 3.9 deleted)
New references added
Terms and Definitions
3.1 to 3.6
Terms and Definitions
3.1 to 3.22
New terms & definitions added
ISO 15223-1:2016 Table 1 – Symbols to convey information essential for proper use ISO 15223-1:2021 Table 1 – Symbols to convey information essential for proper use
5.1.1 to 5.1.7 5.1.1 to 5.1.7 Same
Not Applicable 5.1.8 Importer New symbol added
5.1.9 Distributor New symbol added
5.1.10 Model Number New symbol added
5.1.11 Country of Manufacturer New symbol added
5.2.1 to 5.2.9 5.2.1 to 5.2.9 Same
Not Applicable 5.2.10 Sterilized using vaporized hydrogen peroxide New symbol added
5.2.11 Single sterile barrier system New symbol added
5.2.12 Double sterile barrier system New symbol added
5.2.13 Single sterile barrier system with protective packaging inside New symbol added
5.2.14 Single sterile barrier system with protective packaging outside New symbol added
5.5 IVD Specific 5.5 IVD Specific Not applicable
5.6.1 to 5.6.6 5.6.1 to 5.6.6 Same
5.7.1 5.7.1 Same
Not Applicable 5.7.2 Patient name New symbol added
5.7.3 Patient identification New symbol added
5.7.4 Patient information website New symbol added
5.7.5 Health care center or Doctor New symbol added
5.7.6 Date New symbol added
5.7.7 Medical Device New symbol added
5.7.8 Translation New symbol added
5.7.9 Repackaging New symbol added
5.7.10 Unique Device Identifier New symbol added

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