Search F2 TechNotes
Categories
- ASCA Program
- ATEX Directive 2014/34/EU
- Batteries
- CE marking
- Consulting
- EMC Directive 2014/30/EU
- EMC Testing
- EN 60601-1
- EU Battery Regulation (EU)2023/152
- EVs
- FCC
- FDA
- Field Label
- General Product Safety Directive 2001/95/EC
- General Product Safety Regulation (EU) 2023/988
- GPSR
- GPSR (EU)2023/988
- IEC 60601-1-9
- International Testing
- IP Testing
- Lasers
- Listing
- Low Voltage Directive 2014/35/EU
- Machinery Directive 2006/42/EC
- Machinery Regulation (EU)2023/1230
- Medical Devices Regulation (EU)2017/745
- PPE Regulation (EU) 2016/425
- Pressure Equipment Directive 2014/68/EU
- Product Testing
- Prop 65
- R&TTE Directive 1999/5/EC
- Radio Equipment Directive 2014/53/EU
- REACH
- RoHS Directive 2011/65/EU
- SPE-1000
- UKCA
- UL 4200A
- UL 60335-1
- UL 61010-1
- UL 62368-1
- UL 94
- US Field Label
-
Recent Posts
Monthly Archives: August 2024
The FDA and Common Electromagnetic (EM) Emitters – What You Need to Know
The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that their product is immune to common Electromagnetic (EM) Emitters, such as RFID Readers, Near-field Communication (NFC) systems, metal detectors, Electronic … Continue reading
Posted in FDA, Product Testing
Comments Off on The FDA and Common Electromagnetic (EM) Emitters – What You Need to Know
Easy Approach to Essential Performance in Medical Devices for FDA
F2 Labs has many conversations every week with medical device manufacturers who are struggling to define Essential Performance for their device. From our experience, the confusion around Essential Performance frequently stems from the fact that what a device manufacturer views … Continue reading
Posted in FDA
Comments Off on Easy Approach to Essential Performance in Medical Devices for FDA
IEC 60601-1-9 Environmentally Conscious Design – What is it?
What exactly is the environmentally conscious design file? You need documentation/policies that show how you are addressing the requirements of that standard. You really should use the standard as guidance (IEC 60601-1-9). Here is some good information on what this … Continue reading
Posted in CE marking, EN 60601-1, IEC 60601-1-9, Medical Devices Regulation (EU)2017/745
Comments Off on IEC 60601-1-9 Environmentally Conscious Design – What is it?