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Recent Posts
- Cracking the Code: Surviving the FDA’s AI-Enabled Medical Device Guidance (With Sanity Intact)
- CE Marking: Your Electrical Product’s Passport to Europe
- ECHA Adds Five New Substances to SVHC List
- Does Customs Really Check For RoHS in The EU?
- Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice
Monthly Archives: January 2018
FCC – New Labeling and Manual Requirements
The FCC released new guidance and procedures for manufacturers to show compliance with FCC regulations in June 2017. Some of the changes are in the labeling requirements and, notably, the allowance for the use of a Suppliers Declaration of Conformity, or … Continue reading
Posted in Consulting, FCC
Tagged EMC compliance, EMC testing, EMI testing, Emissions, FCC, FCC compliance, FCC ID, FCC Labeling, FCCID, Immunity, SDOC, Suppliers Declaration of Conformity
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EU’s Rapid Alert System for dangerous non-food products
The EU has a direct conduit for market surveillance authorities to communicate information about non-compliant products directly between 31 EU member nations and the European Commission. This system is called the Rapid Alert System, or RAPEX. This is not where … Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, Consulting, EMC Directive 2014/30/EU, EN 60601-1, General Product Safety Directive 2001/95/EC, IP Testing, Lasers, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU
Tagged CE, CE mark, CE marking, EU consumer protection, EU market surveillance, European Commission, European compliance, RAPEX, Rapid Alert System
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IP69 vs. IP69K
We are presented with a request for quote for IP69K testing on a regular basis at F2 Labs. Usually my first reply to the customer is this, “Do you mean IP69 or IP69K?” Believe it or not, there is a … Continue reading
Posted in IP Testing, Product Testing
Tagged IEC 60529, Ingress protection, IP testing, IP69, IP69K, ISO 20653
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