TSO Parts and Critical Components

P

PHANTOM

#1
An 8130-3 tag for a PMA part going to a EU country must contain the phrase: "This PMA part is not a critical component" (assuming it really isn't critical"). But what about TSO parts, they can be critical also? But the EU Bilateral Agreement makes no "critical component" requirement. What am I missing.:cool:
 
Elsmar Forum Sponsor

errhine

Involved - Posts
#2
Re: TSO and critical components

TSO parts can be deemed "critical" if they are on the Catagory Parts List provided by the FAA. A quick discusion with your local MIDO can confirm if you have any critical parts. Here is a link to the CPL provided by the FAA. https://www.faa.gov/aircraft/air_ce...g_best_practice/media/Category_Parts_List.pdf

However, your question seems to be more focused around an 8130-3 Block 12 statement requirements for TSO. The bilateral agreements between FAA and EASA do not require any criticality statement for TSO. A current copy of all bilaterals can be found on the FAA website. http://www.faa.gov/aircraft/air_cert/international/bilateral_agreements/baa_basa_listing/
 

Marc

Fully vaccinated are you?
Leader
Admin
#3
Re: TSO and critical components

A belated Thank You for your help with this one, errhine. It is appreciated.
 
Thread starter Similar threads Forum Replies Date
A TSO (Technical Standard Order) and PMA (Parts Manufacturer Approval) - Differences Federal Aviation Administration (FAA) Standards and Requirements 5
DuncanGibbons FAA approval of articles (PMA, TSO) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
I Material Qualification for TSO (Technical Standard Order) Authorization Federal Aviation Administration (FAA) Standards and Requirements 6
S ETSO, TSO and EASA Form 1 - Do I need the ETSO approval for the installation? EASA and JAA Aviation Standards and Requirements 3
S EU MDR-Replacement Parts when not manufacture is not yet EU MDR compliant US Medical Device Regulations 1
P IMDS Multiple parts RoHS, REACH, ELV, IMDS and Restricted Substances 1
E How to isolate multiple APPLIED PARTS IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Gage Measuring 15 Parts at a Time Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
H Better to retain previous made parts or one part that is perfect Reliability Analysis - Predictions, Testing and Standards 2
K Looking for a tape to perform cross hatch test on powder coating parts Reliability Analysis - Predictions, Testing and Standards 3
A Are defective returned spare parts to be considered as a complaint? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
G Lifecycle / Expected Service Life of Steel Parts Other Medical Device and Orthopedic Related Topics 5
G Shipping Validation of Non-Sterile Parts? Other Medical Device and Orthopedic Related Topics 9
L En 62368 How to complete with incomplete parts details CE Marking (Conformité Européene) / CB Scheme 4
R MSA on set of parts with low variation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 20
H Project management for automotive parts IATF 16949 - Automotive Quality Systems Standard 7
Q BMW Supplied Parts Quality Management -> Is there any new supplier quality manual? Customer and Company Specific Requirements 0
M Declaration of Conformity and Spare Parts EU Medical Device Regulations 0
T Accessible metal parts connected to secondary ground IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Metal parts bonding/grounding on Class II, internally powered with functional earth? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Flammability requirements for applied parts as per 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K Initial capability studies on similar parts APQP and PPAP 7
Evelyn7E The fastest way to get supplier to ship good parts to you Supplier Quality Assurance and other Supplier Issues 10
B Cl. 9.2 - Moving parts - Applicable only to machinery? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B How to test operator to see if they can catch the defective parts? Manufacturing and Related Processes 8
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4
T Is handling chemically treated parts safe? RoHS, REACH, ELV, IMDS and Restricted Substances 18
R Select the 1 Supplier based on the Parts Durability from 6 Supplier Samples using Minitab Using Minitab Software 11
aleexander Grounding of metallic accessible parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K 10 parts, 4 operators, 3 replications and each part has 3 location to measure. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
M MSA angle issue - Nylon parts using Aberlink 3D Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
I What revalidation is necessary if we change parts in a WFI loop ? Qualification and Validation (including 21 CFR Part 11) 1
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
S For Parts Manufacturer Approval (PMA) Is 100% Inspection Required? Federal Aviation Administration (FAA) Standards and Requirements 2
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
F Recording Nonconforming Purchased Parts Nonconformance and Corrective Action 5
D Suggestions for Ishikawa for hyperdetailed customer - plastic molding automotive parts Nonconformance and Corrective Action 9
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Packaging Long Parts Manufacturing and Related Processes 3
D Separation of F-type applied part and remaining parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
John C. Abnet VDA 6.3 - Question 7.3 - "blocking of parts" VDA Standards - Germany's Automotive Standards 6
I When is necessary to have RoHS declaration on non-electrical parts? REACH and RoHS Conversations 1
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
C Scrapping on production floor - Setup parts 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
G Bad Parts cause Customer line stop IATF 16949 - Automotive Quality Systems Standard 13
G Calibration of "Master Parts" Used as Gauges Calibration Frequency (Interval) 5
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
M Identifying Applied Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Nonconforming parts accepted by operator with intention Human Factors and Ergonomics in Engineering 33

Similar threads

Top Bottom