CE Marking
EU marking for product health and safety conformity
IEC 62443
International standard for IACS cybersecurity frameworks
Quick Verdict
CE Marking ensures EU product safety compliance for market access, while IEC 62443 provides voluntary cybersecurity standards for industrial control systems. Companies adopt CE for legal EU sales; IEC 62443 for OT risk reduction and supplier assurance.
CE Marking
CE Marking (Conformité Européenne)
Key Features
- Manufacturer's self-declaration of EU conformity
- Enables free EEA single market circulation
- Risk-based conformity assessment modules A-H
- OJEU harmonised standards presumption of conformity
- 10-year technical file retention requirement
IEC 62443
IEC 62443: IACS security standards series
Key Features
- Zones and conduits segmentation model
- Security Levels SL-T, SL-C, SL-A triad
- Shared responsibility across stakeholders
- Seven Foundational Requirements FR1-7
- ISASecure modular certification schemes
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
CE Marking Details
What It Is
CE Marking (Conformité Européenne) is the manufacturer's declaration that products comply with applicable EU harmonisation legislation covering health, safety, and environmental protection. It's a regulatory framework under the New Legislative Framework (NLF), focusing on essential requirements via risk-proportionate conformity assessment.
Key Components
- Legislation mapping and essential requirements identification
- Conformity modules (A-H: self-assessment to full quality assurance)
- Technical documentation, EU Declaration of Conformity (DoC)
- CE mark affixing with notified body ID if applicable
- Built on OJEU harmonised standards for presumption of conformity Self-declaration for low-risk; notified body for high-risk.
Why Organizations Use It
Mandated for EEA market access; prevents enforcement, fines, withdrawals. Manages product liability risks, builds stakeholder trust, enables free movement. Offers competitive edge via standards-driven innovation and procurement preference.
Implementation Overview
Map directives, conduct risk assessment, compile technical file, execute assessment, issue DoC, affix mark. Applies to manufacturers/importers of covered products; suits all sizes in electronics, machinery, medical devices. Ongoing post-market surveillance required; notified body audits for high-risk.
IEC 62443 Details
What It Is
IEC 62443 (ISA/IEC 62443 series) is an international consensus-based standard for securing Industrial Automation and Control Systems (IACS). It provides a comprehensive, risk-based framework spanning governance, risk assessment, system architecture, and product development for OT environments, emphasizing safety, availability, and long asset lifecycles.
Key Components
- Four groupings: General (-1), Policies/Procedures (-2), System (-3), Components (-4).
- Seven Foundational Requirements (FR1-7) like identification, integrity, and resource availability.
- Zones/conduits model, Security Levels (SL 0-4) (SL-T, SL-C, SL-A), over 140 component requirements.
- ISASecure modular certification (SDLA, CSA, SSA).
Why Organizations Use It
- Mitigates OT cyber risks, ensures regulatory alignment (horizontal standard).
- Enables shared responsibility among asset owners, integrators, suppliers.
- Reduces downtime, supply chain risks; boosts insurance, procurement advantages.
Implementation Overview
- Phased: governance (2-1), risk assessment/segmentation (3-2), controls (3-3/4-2), certification.
- Applies to critical infrastructure globally; suits all sizes via maturity levels (ML1-4).
Key Differences
| Aspect | CE Marking | IEC 62443 |
|---|---|---|
| Scope | Product safety, health, environmental compliance | Industrial automation cybersecurity lifecycle |
| Industry | All manufacturing sectors, EU/EEA focus | OT/IACS sectors globally, cross-industry |
| Nature | Mandatory EU market access marking | Voluntary consensus cybersecurity standards |
| Testing | Self/third-party conformity assessment modules | Risk assessment, SL certification, audits |
| Penalties | Market bans, fines, product withdrawal | No legal penalties, certification loss |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about CE Marking and IEC 62443
CE Marking FAQ
IEC 62443 FAQ
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