FCC Part 15, 18 harmonized to a standard?

Swimming In The Soup

Starting to get Involved
#1
Hi, I have been trying to find a suitable ISO standard that is harmonized to FCC Part 15 and 18 for a class 2 Medical Device.
I know the general and particular standards for MD but we are confused on the FCC approach. Should we just test to the FCC parts? Any advice is appreciated.
 
Elsmar Forum Sponsor

AllTheThings

Involved In Discussions
#2
Generally, I've asked EMC labs to test to the combined lower "curves" of FCC and CISPR requirements. That way, I can just ignore the differences and know I am passing in my target markets.

Unfortunately, I don't believe there is any harmonized standard between US/FCC and EU/IEC/CISPR requirements.
 

Swimming In The Soup

Starting to get Involved
#4
I called and spoke to FDA. Other than a Q-Sub, I was directed to the consensus standards which I have looked at already. There are no clauses from the FCC section of the CFR.

I believe the 60601-1-2 is required here as medical device regulation supersedes other regulation for medical devices.

Agreement? Other thoughts? Thanks.
 
Thread starter Similar threads Forum Replies Date
thisby_ EMC/FCC part 15 test (NRTL - Nationally Recognized Testing Laboratories) required? US Food and Drug Administration (FDA) 1
amjadrana Medical Device EMC requirements - Canada - Testing to FCC part 18, EN 55011, EN 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R FCC certification (contract manufacturer) TL 9000 Telecommunications Standard and QuEST 1
J Medical System with non-medical device and FCC US Food and Drug Administration (FDA) 5
M CE/FCC/Industry Canada - Standards required for Certification for a Bluetooth Device CE Marking (Conformité Européene) / CB Scheme 6
E Doubts about the FCC regulations for the use of Bluetooth in medical equipment Other Medical Device Related Standards 3
M CE / FCC Compliance for components + final product CE Marking (Conformité Européene) / CB Scheme 2
E Bluetooth Data Transmission Levels - FCC ITU Levels Other Medical Device Related Standards 0
Marc FCC boss says he'll SHAME broadband firms for fibbing on speeds After Work and Weekend Discussion Topics 0
R New product testing for CE marking - Required FCC testing CE Marking (Conformité Européene) / CB Scheme 4
R Is FCC required for Medical Equipment without Radio Frequency Energy? Other US Medical Device Regulations 6
D FCC and ICES Markings for EMC Compliance of Class 1 Medical Device Other US Medical Device Regulations 2
S FCC Rules for Hospital Wireless Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
W Do FCC regulations apply for Medical Devices other than EMC? US Food and Drug Administration (FDA) 3
Marc iPad FCC Teardown and Analysis with photos After Work and Weekend Discussion Topics 4
C FDA Approved Ultrasonic Equipment - FCC Requirements for US sales US Food and Drug Administration (FDA) 4
A Has anyone implemented the Adobe Acrobat Sign Validation Pack to be 21 CFR Part 11 Compliant? ISO 13485:2016 - Medical Device Quality Management Systems 1
H Looking to make inspection faster for part with over 100 dimensions. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
PQ Systems SQCpack Tech Tuesday Webinar 4-Part Series Using SQCpack Software 0
K Device part of combination product certification requirements Medical Device and FDA Regulations and Standards News 3
L "to be treated as APPLIED PART": is shopping in requirements allowed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
X Separation of battery powered FB type applied part IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
N Direct Part Marking of the "CE" symbol- Class I Device EU Medical Device Regulations 1
P Controls over Systems Documentation in 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 1
R Separation and PE Requirements of a Type B Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P Part 21G - Liabilities of a Quality Manager Form 4 Post Holder EASA and JAA Aviation Standards and Requirements 4
W Part 145 Maintenance Data Review EASA and JAA Aviation Standards and Requirements 1
C Part selection for Faro arm MSA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
R Understanding ISO12944 (Part 4) Manufacturing and Related Processes 6
M Part submission warrant with every rev up of drawings APQP and PPAP 2
E Performing a GRR when you get multiple readings over time per part. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
K 13485 do e-signatures have to be 21 CFR Part 11 compliant? ISO 13485:2016 - Medical Device Quality Management Systems 8
I Restricting scope to one part number for one customer IATF 16949 - Automotive Quality Systems Standard 6
P Certifying Staff leaving Part-145 organisation EASA and JAA Aviation Standards and Requirements 4
A Industry standard for stamped part Various Other Specifications, Standards, and related Requirements 2
P Can credentials (ID/PW) used to login be the same as when applying Electronic Signature (Part 11) US Food and Drug Administration (FDA) 2
M Mains on Patient with Part Attached to Protective Earth in Patient Area IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M Documentation accompanying an aerospace part AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
H Better to retain previous made parts or one part that is perfect Reliability Analysis - Predictions, Testing and Standards 2
T Accreditations as part of 9001 - Quality checks on your company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Customer Rejecting Part for Basic Dimension Inspection, Prints (Drawings), Testing, Sampling and Related Topics 16
H Should we stop inspecting a part if its never been rejected? Reliability Analysis - Predictions, Testing and Standards 6
M MSA - Dealing with inherent within-part variation in assemblies Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
C Multiple Part Numbers, IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 2
J IEC 60601 Applied Part - Probes intended to be covered by sheaths IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Saline Infusion- Applied Part, Patient Connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D 21 CFR Part 11 Assessment (Fully Compliant or Not) Qualification and Validation (including 21 CFR Part 11) 9
S Comparing measurement results for a part from two ring gage General Measurement Device and Calibration Topics 3
PQ Systems SQCpack Tech Tuesday Webinar 3-Part Series Using SQCpack Software 4
E Biocompatibility testing of our applied part seems redundant Other Medical Device Related Standards 2

Similar threads

Top Bottom