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 |
