What Standards Does Our Equipment Comply with When Being Exported?

Here is the CE certification explanation and requirements specifically for our automatic production line for drainage bags and urine bags

1. Nature and Classification of Our Equipment

Our equipment is used to produce medical drainage bags and urine bags.
While these bags themselves are classified as medical devices (Class I or II, depending on the country),
the production line is considered an industrial manufacturing machine, not a medical device.

➡️ Therefore, our equipment is not regulated under the EU Medical Device Regulation (MDR 2017/745),
but instead must comply with the Machinery Directive (2006/42/EC) and related electrical and safety directives.

⚙️ 2. Applicable CE Directives

3. CE Certification Process

1. Identify applicable directives and standards

• EN ISO 12100 — Risk assessment for machinery

• EN 60204-1 — Electrical safety for machinery

• EN 61000 series — EMC testing standards

2. Risk Assessment and Safety Analysis
   Identify hazards such as moving parts, high pressure, heat, or pneumatic systems.

3. Testing

• Electrical safety testing (LVD)

• Electromagnetic compatibility (EMC) testing

• Noise or vibration testing (if applicable)

4. Technical Documentation (Technical File)
   Should include:

• General description and drawings of the machine

• Risk assessment report

• Electrical schematics and control logic description

• Test reports (LVD, EMC, etc.)

• Bill of Materials (BOM)

• User Manual and Maintenance Manual

• Declaration of Conformity (DoC) signed by the manufacturer

5. CE Marking
   Once the equipment meets all applicable requirements, the manufacturer may affix the CE mark and issue the Declaration of Conformity.
   For complex or potentially hazardous machinery, it is recommended to involve a Notified Body (e.g., TÜV, SGS, Intertek) for assessment.

4. Industry Practice (for Chinese Exporters)

For similar automated production lines:

• Testing and certification are often done by TÜV, SGS, Intertek, or ECM.

• Average testing duration: 2–3 months.

• Typical cost: RMB 30,000–100,000 per line, depending on complexity.

• Many companies use self-declaration for simpler lines, but obtain third-party EMC/LVD test reports for credibility.

✅ 5. Summary

Would you like to check our CE document? You can find it on our website: Resources.