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- Are test standards necessary?
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- What is CE marking and why is it needed?
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- What are the responsibilities of the equipment manufacturer (CE marking)?
- What happens if the product does not meet all CE marking requirements?
- Are the application of test standards mandatory?
- When can a manufacturer self-certify their product?
- Is CE marking mandatory for all products?
- If the equipment components are certified, is certification of the final equipment required?
- What is a notified body?
- Dimensions and appearance of the CE marking
- Where can I find directives and related standards?
- What if a directive or standard has changed?
- How to validate the product?
- Certification of management systems
- Are annual maintenance audits mandatory?
- For what period is the conformity assessment contract concluded?
- What do significant and minor non-conformity mean?
- From when is it necessary to comply with the ISO 45001 standard?
- When is it necessary to comply with the ISO 22000 standard?
- How to understand the concept of equivalent certificate?
- Where can standards be purchased?
- Use of certification logos and marks
- Is certification possible in different institutions?
- How does certification of management systems help to gain a foothold in the market?
- How to distinguish whether the certificate is accredited?
- In which areas is ISO 13485 mandatory?
- Is it necessary to have a management system?
- Which certificates are most useful in the European Union?
- Multilateral Agreement of the European Accreditation Organization
- How to properly check the company's certificate?
- Product testing FAQ
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- PRODUCT TESTS
- Accreditation of Sertika testing laboratory
- Electrical medical equipment
- Electrical Equipment Safety Testing for Medical Devices LST EN 60601-1
- Electrical Equipment Safety Testing for Medical Device Alarm Systems LST EN 60601-1-8
- Electrical Equipment Safety Testing for Medical Infusion Pumps and Controls LST EN 60601-2-24
- Electrical Equipment Safety Testing for Medical Beds LST EN 60601-2-52
- Electrical Equipment Safety Testing for Medical Supply Units LST EN ISO 11197
- Electrical Equipment Safety Testing for assistive equipment LST EN 21856
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