RoHS
EU regulation restricting hazardous substances in EEE
ISA 95
International standard for enterprise-control system integration.
Quick Verdict
RoHS mandates hazardous substance limits in EEE for EU market access, while ISA 95 provides voluntary models for enterprise-manufacturing integration. Companies adopt RoHS for legal compliance and ISA 95 to reduce integration costs and enable data-driven operations.
RoHS
Directive 2011/65/EU (RoHS 2)
Key Features
- Homogeneous material limits: 0.1% for most substances
- Restricts ten hazardous substances in all EEE
- Open scope unless explicitly excluded categories
- Time-limited exemptions via delegated directives
- Requires technical file and Declaration of Conformity
ISA 95
ANSI/ISA-95 Enterprise-Control System Integration
Key Features
- Purdue levels 0-4 hierarchy for system boundaries
- Activity models defining manufacturing operations
- Object models for equipment, materials, personnel
- Standardized Level 3-4 transactions and messaging
- Alias services for identifier mapping
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
RoHS Details
What It Is
Directive 2011/65/EU (RoHS 2) is an EU regulation restricting hazardous substances in electrical and electronic equipment (EEE). It aims to protect health and environment by limiting risks in waste management, complementing WEEE Directive. Scope covers all EEE unless excluded, using homogeneous material thresholds: 0.1% w/w (0.01% for Cd).
Key Components
- Ten restricted substances: Pb, Hg, Cd, Cr(VI), PBB, PBDE, DEHP, BBP, DBP, DIBP.
- Annexes III/IV for time-limited exemptions.
- IEC 63000 for technical documentation; IEC 62321 for testing.
- Compliance via EU Declaration of Conformity (DoC) and 10-year technical file retention.
Why Organizations Use It
Mandated for EU market access; prevents fines, recalls. Drives supply chain governance, substitution innovation, recyclability. Enhances ESG reputation, level playing field.
Implementation Overview
Risk-based: scope analysis, BoM review, supplier declarations, tiered testing (XRF screening, ICP-MS/GC-MS confirmation), exemption tracking. Applies to manufacturers/importers globally selling EEE; no certification but market surveillance audits.
ISA 95 Details
What It Is
ISA-95 (ANSI/ISA-95, IEC 62264) is an international framework for integrating enterprise business systems like ERP with manufacturing operations and control systems like MES. Its primary purpose is to define consistent information models, hierarchies, and exchanges across Levels 0-4 of the Purdue model, focusing on the Level 3-4 interface to reduce integration risks, costs, and errors.
Key Components
- Hierarchical levels (0-4) based on Purdue Reference Model
- Activity models (Part 3), object models (Parts 2/4) for equipment, materials, personnel
- Eight parts covering terminology, transactions (Part 5), messaging (Part 6), aliases (Part 7)
- No formal certification; compliance via architectural alignment and models
Why Organizations Use It
- Enables semantic consistency, faster integrations, better OEE and traceability
- Supports IT/OT collaboration, regulatory audits, cybersecurity segmentation
- Reduces custom mapping, scales multi-site operations, builds data governance
Implementation Overview
- Phased: assessment, canonical modeling, pilot, rollout with governance
- Applies to manufacturing industries globally; involves workshops, MDM, middleware
- No mandatory audits; success measured by KPIs like integration time reduction (179 words)
Key Differences
| Aspect | RoHS | ISA 95 |
|---|---|---|
| Scope | Hazardous substances in EEE materials | Enterprise-control system integration models |
| Industry | Electrical/electronic equipment manufacturers | Manufacturing operations across industries |
| Nature | Mandatory EU product restriction directive | Voluntary integration reference framework |
| Testing | XRF/ICP-MS on homogeneous materials | No formal testing; model conformance |
| Penalties | Fines, recalls, market bans by states | No penalties; integration risks only |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about RoHS and ISA 95
RoHS FAQ
ISA 95 FAQ
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