ISO 15223-1: Symbols for Labeling and Packaging Fundamentals Training by Tonex
Clear, compliant labeling is the frontline of safe medical device use. This course demystifies ISO 15223-1 and shows how to apply standardized symbols to packaging, IFUs, and eIFU ecosystems with precision. You will learn how symbols reduce language risk, accelerate market access, and align with regulator expectations across regions.
Cybersecurity matters too—connected devices rely on symbols to communicate data protection, tamper evidence, and update requirements. Proper iconography supports secure handling, storage, and decommissioning of digital assets. You will leave with a practical toolkit for building symbol libraries, change-controlling updates, and auditing conformity without slowing innovation.
Learning Objectives
- Explain scope, terms, and structure of ISO 15223-1 and related standards
- Map symbols to device lifecycle stages and packaging hierarchies
- Build a compliant symbol legend for IFU, labels, and eIFU repositories
- Align documentation, UDI, and QMS procedures with symbol usage
- Draft verification and validation steps for symbol correctness and legibility
- Describe how symbols support cybersecurity controls and secure device handling
Audience
- Regulatory Affairs Professionals
- Quality and Compliance Managers
- Technical Writers and Labeling Specialists
- Packaging Engineers
- Product and Program Managers
- Cybersecurity Professionals
Course Modules
Module 1 – Standard Essentials
- Scope and applicability across device classes
- Definitions, normative references, and structure
- Symbol intent versus literal translation pitfalls
- Relationship to ISO 20417 and IEC 60601 family
- Regional expectations EU, US, UK, Canada, APAC
- Risk management links with ISO 14971
Module 2 – Symbol Taxonomy
- Manufacturer, date, batch, UDI-DI relations
- Sterilization, aseptic, and asepsis states
- Storage conditions, limits, and transport
- Single-use, re-use, reprocessing boundaries
- Warnings, contraindications, and hazards
- eIFU, QR, digital access, and traceability
Module 3 – Packaging Application
- Primary vs secondary pack symbol placement
- Readability, contrast, and durability rules
- Size scaling, minimums, and print quality
- Multi-language packs and space economy
- Country variants and market-specific adders
- Environmental and sustainability markings
Module 4 – Documentation Integration
- IFU symbol legends and consistency checks
- BOM, label specs, and artwork control
- QMS procedures and training records
- Change control, redlines, and approvals
- Supplier artwork and file exchange hygiene
- Audit trails and design history linkage
Module 5 – Compliance and Testing
- Verification of legibility and permanence
- Validation via usability and comprehension
- Sample plans and acceptance criteria
- Nonconformance handling and CAPA ties
- Tech file readiness and notified body views
- Post-market surveillance signal capture
Module 6 – Cyber and Digital Readiness
- Symbols for data privacy and secure handling
- Tamper evidence, firmware, and update cues
- eIFU availability, revision, and authenticity
- UDI carriers, scanners, and data integrity
- Field service labeling and decommissioning
- Incident communication and recall clarity
Ready to make labeling a competitive advantage while meeting global expectations with confidence Join Tonex to master ISO 15223-1 symbols, reduce compliance risk, and build a scalable labeling system that supports safe, secure medical device adoption. Enroll now to secure your seat.