Huanghai Dissolution Testers Achieve Full CE Certification Under Machinery and EMC Directives
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Huanghai Pharmaceutical Instruments announces the successful completion of CE conformity assessment for its full dissolution tester product line. The certification covers both the EU Machinery Directive (2006/42/EC) and the Electromagnetic Compatibility Directive (2014/30/EU).
Products Covered
The CE certification covers the following Huanghai dissolution tester models:
| Product Line | Models |
|---|---|
| RCZ Intelligent Dissolution Testers | RCZ-12A, RCZ-8A, RCZ-8N, RCZ-6N, RCZ-1B |
| ZQY Automatic Sampling Systems | ZQY-12A, ZQY-8A |
| RCZ-QY Automatic Sampling Systems | RCZ-QY12, RCZ-QY8 |
| SY Multi-Function Tablet Tester | SY-6DN |
What the Certification Covers
Machinery Directive 2006/42/EC — Technical Construction File
The Machinery Directive assessment required a complete Technical Construction File (TCF) documenting all design decisions, hazard identification, and risk reduction measures. The TCF was compiled against three harmonized European standards:
EN ISO 12100:2010 — Safety of machinery: General principles for design — Risk assessment and risk reduction
This standard provided the framework for identifying mechanical, electrical, thermal, and ergonomic hazards across all dissolution tester models and documenting the protective measures integrated into the design.
EN 60204-1:2018 — Safety of machinery: Electrical equipment of machines
Electrical safety testing verified that the wiring systems, insulation, grounding arrangements, and protective devices in the dissolution testers meet the essential safety requirements for industrial and laboratory machinery placed on the EU market.
EN 61010-1:2010+A1:2019 — Safety requirements for electrical equipment for measurement, control, and laboratory use
This standard addresses hazards specific to laboratory instruments, including protection against burns from heated dissolution media, chemical exposure from solvent-based dissolution media, and measurement system integrity under laboratory operating conditions.
EMC Directive 2014/30/EU — EMC Technical File
The electromagnetic compatibility assessment required a full EMC Technical File compiled against EN IEC 61326-1:2021.
The EN IEC 61326-1 test program covers:
Emission tests:
- Conducted emission measurement (power line and signal line)
- Radiated emission measurement (antenna at 3-meter and 10-meter distance)
Immunity tests:
- Radiated radio-frequency electromagnetic field immunity (80 MHz–1000 MHz, 3 V/m)
- Electrostatic discharge immunity (contact and air discharge)
- Electrical fast transient / burst immunity (power ports and I/O lines)
- Surge immunity (line-to-line and line-to-earth)
- Immunity to conducted disturbances induced by RF fields (0.15–80 MHz)
All Huanghai dissolution tester models passed all emission and immunity tests within the limits specified for laboratory instruments in industrial environments.
What This Means for Pharmaceutical Laboratories
EU Market Access
All dissolution tester models listed above are now fully compliant for sale and use within the European Economic Area. Pharmaceutical manufacturers, contract laboratories, and distributors operating under EU GMP licenses can procure and deploy these instruments with confidence that the CE marking represents a complete conformity assessment.
GMP Equipment Qualification Support
The complete technical file — including the TCF, all referenced test reports, and the EC Declaration of Conformity — is available to qualified customers for use in IQ/OQ/PQ documentation. Laboratories completing Design Qualification (DQ) packages can reference Huanghai's conformity assessment documentation directly, reducing the need to independently generate safety assessments for regulatory submissions.
Data Integrity Assurance
The EMC immunity test results are directly relevant to dissolution data integrity. All Huanghai dissolution tester models have demonstrated sustained measurement accuracy under the full EN IEC 61326-1 immunity test battery, providing documented evidence that speed control, temperature regulation, and sampling timing functions maintain performance in electrically noisy laboratory environments.
Frequently Asked Questions
Q: Which Huanghai dissolution tester models are covered by the CE certification?
A: The CE certification covers ten dissolution testing instruments across four product lines: the RCZ Intelligent Dissolution Tester series (RCZ-12A, RCZ-8A, RCZ-8N, RCZ-6N, and RCZ-1B), the ZQY Automatic Sampling Systems (ZQY-12A and ZQY-8A), the RCZ-QY Automatic Sampling Systems (RCZ-QY12 and RCZ-QY8), and the SY-6DN Multi-Function Tablet Tester. Full details are available on Huanghai's certifications page at drugmachines.com/pages/certifications.
Q: What documentation can Huanghai provide for equipment qualification (IQ/OQ/PQ)?
A: For qualified customers, Huanghai can provide the following documentation to support formal IQ/OQ/PQ protocols: (1) EC Declaration of Conformity (signed), (2) EMC Technical File summary, and (3) Technical Construction File index. Laboratories conducting Design Qualification (DQ) under EU GMP Annex 15 may reference this documentation directly in their qualification packages. To request the full compliance documentation set, contact Huanghai's technical team via the contact page.
Q: What does EMC compliance mean for dissolution data reliability in pharmaceutical labs?
A: The EMC Technical File was compiled against EN IEC 61326-1:2021, the harmonized standard for electrical equipment in laboratory environments. The test program includes radiated radio-frequency electromagnetic field immunity (80 MHz–1000 MHz, 3 V/m), electrostatic discharge immunity, electrical fast transient/burst immunity, surge immunity, and conducted RF disturbance immunity (0.15–80 MHz). All models passed within the limits for industrial laboratory environments. For dissolution testing specifically — where paddle speed regulation (typically 50 or 100 RPM per USP <711>), temperature maintenance (37 ± 0.5°C), and timed sampling intervals are critical — EMC immunity directly supports the argument that the instrument will maintain measurement accuracy in electrically noisy environments such as production-adjacent quality control labs.
Request Compliance Documentation
The following documents are available upon request for qualification and procurement purposes:
- EC Declaration of Conformity (signed)
- EMC Technical File summary
- Technical Construction File index
Contact our technical team to request documentation →
Browse CE-certified dissolution testers →
About Huanghai Pharmaceutical Instruments
Founded by the core team of China's National Pharmaceutical Engineering Research Center (NPERC), Huanghai has 40+ years of experience in pharmaceutical instrument manufacturing. With 97+ registered patents and a product range covering dissolution testing, tablet analysis, ODF manufacturing, and capsule inspection, Huanghai serves pharmaceutical manufacturers, contract research organizations, and quality control laboratories across 30+ countries.