Outgassing - product inside a sealed housing

#1
Good morning Covers
The product is a European pressure transducer for a space application.
For non-metallic products, I expect to see the outgassing values reported in the Declared Materials List. (normal work for a space product, high values are not allowed)
But, the supplier points out the complete assembly is hermetically sealed and any outgassing from non-metallics will be contained inside the housing and will not affect the spacecraft.
I almost agree here, but think if a material outgasses excessively, it could contaminate the electronic circuitry within. So they need to report the outgassing values for the products used during build.
What are your thoughts?
Cheers
Paul
 
Elsmar Forum Sponsor

ChrisM

Involved In Discussions
#2
Is the product designed for use in space? If it is, then the manufacturer should have conducted tests and should be able to provide you with the answers. However if this is a transducer designed for commercial/industrial applications, you are effectively on your own if you have chosen to incorporate it into something that will go into space. Either you will need to change to a product that has been designed for use in space and for which outgassing information is available, or you will need to perform testing to find out (possibly in conjunction with the manufacturer, if they are interested). A starting point will be to obtain the list of materials used in the transducer and check with the NASA and ESA published data on outgassing
 
Thread starter Similar threads Forum Replies Date
A Combination product Canada Medical Device Regulations 2
E UDI on product/packaging levels EU Medical Device Regulations 2
M Drug-Device Combination product CE Marking (Conformité Européene) / CB Scheme 1
H Product Safety & Conformity Representative (PSCR) Training Company IATF 16949 - Automotive Quality Systems Standard 0
X Design stage overview (Product specification) EU Medical Device Regulations 3
9 Responsibility for Product Paid for but not yet Shipped AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Product Acceptance Software (PAS) PROCEDURE (BOEING D6-51991) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Combo Product Assembly Process OQ Qualification and Validation (including 21 CFR Part 11) 0
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
A Product Liability Insurance coverage for EU Importer by UK Manufacturer EU Medical Device Regulations 2
L Temporary Product Deviation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
FRA 2 FDA Product NCRs- Quality Review Nonconformance and Corrective Action 6
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Aftermarket product PPAP approval IATF 16949 - Automotive Quality Systems Standard 1
G How to find applicable standards for a new product? EU Medical Device Regulations 6
T Link GMDN code and FDA product code US Medical Device Regulations 5
S Combination Product - Packaging US Food and Drug Administration (FDA) 6
S Can a product option change the product class? CE Marking (Conformité Européene) / CB Scheme 2
H Regarding EMC & Safety retesting requirements of the product CE Marking (Conformité Européene) / CB Scheme 2
Q Product audit assessment IATF 16949 - Automotive Quality Systems Standard 4
S Submit under a new product code in a 510k? US Medical Device Regulations 5
P Product Quality Review API-GMP Manufacturing and Related Processes 0
D Shelf life of non sterile class IIb product. ISO 13485:2016 - Medical Device Quality Management Systems 1
A Product Update and executing only affected System Tests, leaving out unaffected ones IEC 62304 - Medical Device Software Life Cycle Processes 5
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
J Enough for PSUR to cover product family? (Procedure packs, not the legal manufacturer) EU Medical Device Regulations 1
B Product registration CE Marking (Conformité Européene) / CB Scheme 2
V Product naming: Same name - different perfume & status CE Marking (Conformité Européene) / CB Scheme 0
E Marketing, product and system requirements IEC 62304 - Medical Device Software Life Cycle Processes 2
C PPAP requirements for consumer product APQP and PPAP 2
C How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)? Other US Medical Device Regulations 4
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
S Classification of product (measuring or not?) CE Marking (Conformité Européene) / CB Scheme 5
Ron Rompen 4.4.1.2 Product Safety Compliance IATF 16949 - Automotive Quality Systems Standard 29
M Supplier Control for Unique Product ISO 13485:2016 - Medical Device Quality Management Systems 6
R Shelf life of product Other Medical Device Related Standards 4
D One Software as Medical Device product or two? EU Medical Device Regulations 4
J Aerospace Product Key Characteristics AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
F Product classification according to the 60601-2-57: Particular requirements [...] of non-laser light sources [...] IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Reworking MDD product w MDR labeling CE Marking (Conformité Européene) / CB Scheme 5
D Regulations covering Sterile product shipments ISO 13485:2016 - Medical Device Quality Management Systems 1
M R&R Studies - how many? per product? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
S Reliability issue - Frequent component failure of the product Reliability Analysis - Predictions, Testing and Standards 2
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L How to deal with the model number symbol for X-RAY PRODUCT Other Medical Device Related Standards 1
B Establishment and Product Registration Procedure - UK & EU UK Medical Device Regulations 0
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2

Similar threads

Top Bottom