CE certification for household oxygen concentrators


With the improvement of people’s living standards and the increasing awareness of health care, oxygen inhalation will gradually become an important means of family rehabilitation. Household oxygen concentrators are easy to use, light in size, and easy to move, so they are loved by health-care people. If a household oxygen concentrator wants to export to the EU, it needs to apply for CE certification to enter the EU market and comply with EU safety standards. So how to apply for CE certification for household oxygen concentrators ? Here we take a look.

Materials required for CE certification of household oxygen concentrators:

1. Application

2. A copy of the business license of the applicant, manufacturer, and production plant

3. Product manual

4. Description of the differences between products of various models in the same application unit

5. List of key components or main raw materials

6. Product size drawing, assembly drawing and size drawing of each part

7. Other required documents

CE certification application process for household oxygen concentrators:

1. Project application – submit a test application to the supervision of the testing agency.

2. Data preparation – According to the testing requirements, the company prepares relevant documents.

3. Product testing -the company sends the samples to be tested to the laboratory for testing.

4. Compilation report -The certified engineer compiles the report based on the qualified test data.

5. Submit for review -the engineer will review the complete report.

6. Issuing a certificate – after the verification is correct, a certificate will be issued.

CE certification cycle for household oxygen concentrators

The CE certification cycle depends on the test cycle of the product. For product certification, it usually takes 3-6 working weeks, and then the test cycle is different depending on each product.

CE certification fee for household oxygen concentrator

CE certification fee is also determined according to different products, the overall fee = certification fee + testing fee + service fee

Validity Period of CE Certification for Household Oxygen Concentrator

In fact, CE certification has no relative meaning. The validity period of CE certification is based on when the product standard expires. There is no specific stipulation on when and when a standard expires. It is stipulated by the European Union. As for when the standard is changed, it can only be determined by the notice from the European Union. Generally, the product can be used for at least half a year to a year, because after the new regulations are released, The old rules can also be used for six months to one year.