SBS - The best value in QMS software

Coverage and differences: EN 60601-1:2006+A12:2014 Vs AAMI/IEC 60601-1:2005+AMD1:2012

A

Ash Watson

Starting to get Involved
#1
#1
I have BS EN 60601-1:2006+A12:2014, but the device being developed is destined for US market, so ANSI/AAMI ES60601-1:2005 (R2012) applies.

Can anyone advise/comment on where in general the differences - if any - exist and whether complying to the european version (particularly during design, development and verification) will cover for the FDA's Recognised Consensus Standard.

...the ANSI/AAMI document is expensive!
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
P

primavesvera

Involved In Discussions
#2
#2
When we submitted 510(k) in 2018, we didn't have any problem. The test report was done by a certified lab based on the EN version of the standard.
But it was in 2018, so maybe to wait for someone with recent experience (I think their pilot project for accreditation of laboratories is still on-going).
 
A

Ash Watson

Starting to get Involved
#3
#3
primavesvera said:
When we submitted 510(k) in 2018, we didn't have any problem. The test report was done by a certified lab based on the EN version of the standard.
But it was in 2018, so maybe to wait for someone with recent experience (I think their pilot project for accreditation of laboratories is still on-going).
Click to expand...
Thanks primavesvera, so I can probably proceed against EN version without too much risk for the time being.
Was wondering mainly if there are any glaring differences in documentation or specifications in the ES version
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Impact of an MDSAP certificate with all countries coverage Other Medical Device Regulations World-Wide 8
A Internal Audit - Coverage for ISO 9001:2015 Internal Auditing 4
A Coverage factor in calibration certificate for a multimeter General Measurement Device and Calibration Topics 4
B ISMS Certified - Any requirement for Insurance Coverage for Infrastructure Assets? IEC 27001 - Information Security Management Systems (ISMS) 4
K ISO9001:2008 Internal Audit Period Coverage Internal Auditing 18
J Code Coverage in VHDL and Verilog for Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 17
V Coverage of Process Failures in dFMEA (Scope/Boundaries for Inclusion) & vice versa Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
D Influence of the Coverage Factor - Worksheets based on the Average and Range Method Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
DanteCaspian Operator Break Coverage - Custom injection mould shop Manufacturing and Related Processes 9
G Coverage of ISO 14001 within an organization - Implementation ISO 14001:2015 Specific Discussions 5
N Painting experts: Coverage area for each litre of paint and thinner mix Manufacturing and Related Processes 5
C ISO 14001 Coverage and exclusion - Testing of electonics devices ISO 14001:2015 Specific Discussions 2
B Opinions on the best conference to go to in terms of ISO 14001 coverage ISO 14001:2015 Specific Discussions 7
N R&R for Differences between 2 measurements Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
A VDA2 - 6th edition June 2020 | Differences for the previous VDA2 VDA Standards - Germany's Automotive Standards 0
S SAE AS13004 vs. SAE J1739 - What are the main differences? FMEA and Control Plans 0
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
A MSA results differences - Supplier results vs. My results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
DuncanGibbons Clear differences between ISO 13485 and AS 9100D requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
K Differences between Manufacturing Process Audit & Layered Process Audit Lean in Manufacturing and Service Industries 4
S Differences in CB expectations between the US and Europe Registrars and Notified Bodies 3
M Authorized Rep (AR), competent authority, NCA and notified body - Differences EU Medical Device Regulations 9
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab ISO 17025 related Discussions 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab US Food and Drug Administration (FDA) 6
P HVAC System vs Air Handling Unit (AHU) - Differences Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
G Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions ISO 13485:2016 - Medical Device Quality Management Systems 16
M What are the differences between "Process Flowchart form" and "Process Flow Diagram form"? IATF 16949 - Automotive Quality Systems Standard 4
K Differences between EN ISO 11607-1:2009 vs. 2017 Other Medical Device Related Standards 1
M What are the differences between TIR 13004:2013 and TIR 33? Other Medical Device Related Standards 2
I "Method" vs "Process" - Differences Document Control Systems, Procedures, Forms and Templates 33
S The key differences in 510k types - Traditional vs. Abbreviated vs. Special US Food and Drug Administration (FDA) 0
M Differences in CQE, CSTE, CSQA, CQA Professional Certifications and Degrees 3
H Differences between CQI 15 and CQI 17 IATF 16949 - Automotive Quality Systems Standard 0
L GMDN code differences, Manufacturer and Sponsor Other Medical Device Regulations World-Wide 3
F UMDN vs GMDN - What are the differences? EU Medical Device Regulations 1
D AS9100D vs AS9120B differences AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A ISO 13485:2003 vs ISO 13485:2016 - What are the differences between the two? ISO 13485:2016 - Medical Device Quality Management Systems 1
F EU IVD registrations - CFG or CFS - Differences EU Medical Device Regulations 1
C Differences between IATF 16949 and AS9100 IATF 16949 - Automotive Quality Systems Standard 13
P Differences CSQA vs CQA ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
T PPAP differences between TS16949 and VDA APQP and PPAP 1
E Differences between IEC 60601-1-11:2015 and 2010 Other US Medical Device Regulations 0
J Differences between a Risk Management Plan vs. Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Y Differences between the Classic 7 QC Tools and New QC Tools Quality Tools, Improvement and Analysis 3
M Standard work, standardized work instruction & work instruction: What are differences IATF 16949 - Automotive Quality Systems Standard 7
M Barrier Free vs. Wheelchair Accessible - Differences Occupational Health & Safety Management Standards 1
F IEC 60601-1-2: Differences 2007 and 2015 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R 510(k) Executive Summary vs 510(k) Summary - Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Differences between IATF 16949:2016 vs ISO/TS 16949:2009 IATF 16949 - Automotive Quality Systems Standard 13
A ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom