Huanghai Dissolution Testers Achieve Full CE Certification Under Machinery and EMC Directives
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April 2026 | Shanghai, China
Huanghai Manufacturing Technology of Shanghai Ltd. announces the successful completion of CE conformity assessment for its full тестер растворения product line. The certification covers both the EU Machinery Directive (2006/42/EC) and the Electromagnetic Compatibility Directive (2014/30/EU), and has been independently attested by UDEM Uluslararası Belgelendirme Denetim Eğitim Merkezi.
The attestation of conformity (Certificate No. M.2026.206.C139011) was registered on April 22, 2026, and is valid through April 21, 2031.
Products Covered
The CE certification covers the following Huanghai тестер растворения 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 таблетка 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, Reference No. MD-TCF-260402-84864) documenting all design decisions, hazard identification, and risk reduction measures. The TCF was compiled against three harmonized European стандарты:
EN ISO 12100:2010 — Safety of machinery: General principles for design — Risk assessment and risk reduction
This стандарт provided the framework for identifying mechanical, electrical, thermal, and ergonomic hazards across all тестер растворения models and documenting the protective measures integrated into the design.
EN 60204-1:2018 — Safety of machinery: Electrical equipment of machines
Electrical safety тестирование verified that the wiring systems, insulation, grounding arrangements, and protective devices in the dissolution testers meet the essential safety requirements for industrial and лаборатория machinery placed on the EU market.
EN 61010-1:2010+A1:2019 — Safety requirements for electrical equipment for measurement, control, and лаборатория use
This стандарт addresses hazards specific to лаборатория instruments, including protection against burns from heated dissolution media, chemical exposure from solvent-based dissolution media, and measurement system integrity under лаборатория operating conditions.
EMC Directive 2014/30/EU — EMC Technical File
The electromagnetic compatibility assessment required a full EMC Technical File (Reference No. TESH26040284865), generated by Shanghai Global тестирование Services Co., Ltd against EN IEC 61326-1:2021. тестирование was conducted from April 10 to April 20, 2026.
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 тестер растворения models passed all emission and immunity tests within the limits specified for лаборатория instruments in industrial environments.
Independent Third-Party Attestation
While CE marking can be completed through manufacturer self-declaration under most Machinery Directive scenarios, Huanghai elected to engage UDEM (Uluslararası Belgelendirme Denetim Eğitim Merkezi, Ankara, Turkey) for an independent audit and attestation of its complete technical file.
UDEM's attestation confirms that the technical documentation — including the TCF, EMC technical file, risk assessments, and all test reports — was reviewed against the directives 2006/42/EC and 2014/30/EU and found to be complete and conformant. Certificate validity can be verified directly through udem.com.tr.
Certificate details:
- Certificate No.: M.2026.206.C139011
- Initial Assessment Date: April 21, 2026
- Registration Date: April 22, 2026
- Expiry Date: April 21, 2031
What This Means for фармацевтический Laboratories
EU Market Access
All тестер растворения models listed above are now fully compliant for sale and use within the European Economic Area. фармацевтический 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, independently attested 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 тестер растворения 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 лаборатория environments.
Frequently Asked Questions
Q: Which Huanghai тестер растворения models are covered by CE Certificate M.2026.206.C139011?
A: Certificate M.2026.206.C139011 covers ten тестирование растворения instruments across four product lines: the RCZ Intelligent тестер растворения 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 таблетка Tester. The certificate is valid through April 21, 2031. Full details are available on Huanghai's certifications page at drugmachines.com/pages/certifications.
Q: What is UDEM and how does its attestation differ from a CE self-declaration?
A: UDEM (Uluslararası Belgelendirme Denetim Eğitim Merkezi) is an independent third-party certification body based in Ankara, Turkey. Under the EU Machinery Directive (2006/42/EC), most general-purpose лаборатория instruments may achieve CE marking via manufacturer self-declaration — meaning the manufacturer compiles the technical file and issues the Declaration of Conformity without external review. Huanghai chose a higher стандарт: engaging UDEM to independently audit the Technical Construction File (TCF Reference MD-TCF-260402-84864) and EMC Technical File (TESH26040284865) against both directives. This independent attestation provides procurement teams and regulatory auditors with a verifiable, third-party-reviewed соответствие record — a meaningful distinction when supporting GMP qualification packages.
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) Certificate of Attestation M.2026.206.C139011, (3) EMC Technical File summary (TESH26040284865), and (4) Technical Construction File index (MD-TCF-260402-84864). Laboratories conducting Design Qualification (DQ) under EU GMP Annex 15 may reference this documentation directly in their qualification packages. To request the full соответствие documentation set, contact Huanghai's technical team via the contact page.
Q: What does EMC соответствие mean for dissolution data reliability in фармацевтический labs?
A: The EMC Technical File (TESH26040284865) was compiled against EN IEC 61326-1:2021, the harmonized стандарт for electrical equipment in лаборатория 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 лаборатория environments. For тестирование растворения 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.
Q: How long is the CE certification valid and when is it renewed?
A: Certificate M.2026.206.C139011 was issued on April 22, 2026 and is valid through April 21, 2031 — a five-year term consistent with стандарт UDEM attestation practice. Prior to expiry, Huanghai will undergo a renewal assessment covering any design changes made since initial certification, updated harmonized стандарты, and any new models added to the product line. Customers with long-term equipment procurement programs can plan qualification cycles accordingly. Certificate validity can also be verified independently through UDEM's registry at udem.com.tr.
Request соответствие Documentation
The following documents are available upon request for qualification and procurement purposes:
- EC Declaration of Conformity (signed)
- Certificate of Attestation (M.2026.206.C139011)
- EMC Technical File summary
- Technical Construction File index
Contact our technical team to request documentation →
Browse CE-certified dissolution testers →
About Huanghai Manufacturing Technology of Shanghai Ltd.
Founded by the core team of China's National фармацевтический Engineering Research Center (NPERC), Huanghai has 40+ years of experience in фармацевтический instrument manufacturing. With 97+ registered patents and a product range covering тестирование растворения, таблетка анализ, ОРД manufacturing, and капсула inspection, Huanghai serves фармацевтический manufacturers, contract research organizations, and quality control laboratories across 30+ countries.