Question Stainless Steel grade required for Medical Devices

M

madannc

#1
HI All

Does anyone know if there are any regs regarding the grade of stainless steel required for rollers that transfer plastic moulded medical probe tips from the press to packaging machines?

thx Nigel
 
Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#2
I tend to think the concern would be about cleanliness, hygiene, and contamination of the product [from oxidation flakes from the roller or other material] from ANY of the process equipment used in transferring and packaging a product, but my understanding after working with various stainless steel alloys for years is most grades would be capable of service for such process equipment.

In direct answer to your question, a quick perusal of the FDA regs did not turn up any comment pertaining to material specifications of transfer equipment. A direct question to FDA would resolve the matter definitively (be sure to ask for a written response!)
 

Wes Bucey

Quite Involved in Discussions
#3
These weren't for implants, but for rollers used to transport product to a packaging machine
stainless steel required for rollers that transfer plastic moulded medical probe tips from the press to packaging machines?
- no human patient contact involved - internal or external.
 
M

madannc

#4
Thx Wes much appreciated, you have confirmed my initial thoughts, there seems to be a view here that as its for medical devices we need to use 316L which is typically used for implants (hip replacements etc). My opinion was that as long as there are no contamination, oxidation issues or damage/wear being caused to the moulded tips we do not need to have such a high grade.

once again thx

Nigel:thanx:

just read second post - yes for transfer equipment NOT implants
 
J

Jimmy the Brit

#5
Thx Wes much appreciated, you have confirmed my initial thoughts, there seems to be a view here that as its for medical devices we need to use 316L which is typically used for implants (hip replacements etc). My opinion was that as long as there are no contamination, oxidation issues or damage/wear being caused to the moulded tips we do not need to have such a high grade.
Hi Nigel,

We tend to use 316L on all manufacturing equipment for its chemical resistance to cleaning agents. We have found that 314 gets corroded when using hypochlorites and some tertiary ammonium based cleaning agents and it just become easier to specify the more resistant low carbon grade to improve equipment longevity. I certainly don't think that there is any specific requirement for medical device manufacturing equipment, beyond the sensible parameters Wes suggests.

Jimmy
 
Thread starter Similar threads Forum Replies Date
J ASTM A313 - Testing of 304ss (Stainless Steel) question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J Question about certificate/norm for stainless steel tubes Various Other Specifications, Standards, and related Requirements 1
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 0
C Gauge R&R Question Using Minitab Software 1
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
K Question on MDR classification EU Medical Device Regulations 4
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
D Work Instruction Question ISO 13485:2016 - Medical Device Quality Management Systems 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
John C. Abnet VDA 6.3 - Question 7.3 - "blocking of parts" VDA Standards - Germany's Automotive Standards 6
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question regarding "storage and distribution" ISO 13485:2016 - Medical Device Quality Management Systems 1
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
S Study sign off question / responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 3
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
M Question for Auditors - "Off the Record" Conversation? General Auditing Discussions 14
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
A Question on Authorized Representative in Malaysia Other Medical Device Regulations World-Wide 3
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
T Question for: Cg & Cgk calculation General Measurement Device and Calibration Topics 3
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 6
hogheavenfarm GDT Flatness measurement question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 11
dinaroxentool Question about FDA Classification of a Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Another DFAR question 252.225-7009 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
F Conflict Mineral Smelter Question RoHS, REACH, ELV, IMDS and Restricted Substances 8
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D API 6A Certification Question Oil and Gas Industry Standards and Regulations 4
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
C MDR - Question around software accesories EU Medical Device Regulations 2
K My question is, what/when is a nonconformity? Therefore what requires an NCR? Nonconformance and Corrective Action 9
Watchcat Authoritative References about the Research Question? Quality Tools, Improvement and Analysis 0
T Question about Quality Department employee position titles Quality Manager and Management Related Issues 10
N Question on creepage/clearance requirements for HF Active Accessories for 2nd edition 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Question: How to create an IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 3
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
O Mitutoyo Digital Caliper to PC USB question General Measurement Device and Calibration Topics 2
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
B Minitab Type 1 Gage Study on True Position Question Measurement Uncertainty (MU) 1

Similar threads

Top Bottom