Maximal limit of Aluminum in Polymer Medical Device Implants (EU)

J

jan.stepanek

#1
#1
Dear All,

I would like to please you about advice where (in which document) I can find a maximal limit of Aluminum in polymer medical device implants. I mean EU market and EU regulation.

Thanks a lot Jan
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Heat Sealers Upper and lower limit setting during OQ for Heat Sealer Qualification and Validation (including 21 CFR Part 11) 0
T The “use-by“ time limit - Terminology discrepancy - MEDDEV & HS EU Medical Device Regulations 0
M Proper way to develop LCL when only given a lower spec limit Reliability Analysis - Predictions, Testing and Standards 7
B Narrow limit gauging Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
shimonv Symbol for temperature limit EU Medical Device Regulations 6
H How to control when control limit is out of Specs limit Statistical Analysis Tools, Techniques and SPC 11
K Small Sample - Lower Limit Probability Statistical Analysis Tools, Techniques and SPC 0
J0anne 90 Day Limit Imposed by NB to complete NCs raised at audit Preventive Action and Continuous Improvement 6
I Cleanroom Actions in case of Actions Limit Alarm Qualification and Validation (including 21 CFR Part 11) 3
S Minitab limit definition from R & R Using Minitab Software 4
L P-Chart Control Limit Calculation help Statistical Analysis Tools, Techniques and SPC 1
Q US FDA Standard Limit for Swab Test Microbial and ATP Other US Medical Device Regulations 1
R How to calculate UCL (Upper COntrol Limit) and LCL (Lower Control Limit) Statistical Analysis Tools, Techniques and SPC 5
R Fixing of tolerance limit - Electronic weighing balance with the capacity of 150 Kgs General Measurement Device and Calibration Topics 5
N More Central Limit Theorem Questions Six Sigma 4
P No-go Ring Over the specifiaction limit Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
V Are microbial limit tests required for sterile products? Qualification and Validation (including 21 CFR Part 11) 3
S CpK in Minitab when 0.0 is the lower spec limit Statistical Analysis Tools, Techniques and SPC 7
A 61010-1 Accessible Parts - Limit Values and Crepage and Air Clearance Distances Other Medical Device Related Standards 1
B What is the safe Temperature Limit for Medical Device with blood contact ? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Specific Capability case - Target Value is same as the Lower Limit Capability, Accuracy and Stability - Processes, Machines, etc. 9
A CQE exam primer Control Limit question Statistical Analysis Tools, Techniques and SPC 2
S SPC Control Limit Calculation Statistical Analysis Tools, Techniques and SPC 2
J Exceeding the DC Leakage Current Limit IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
B Setting Lower Control Limit on Attributes Charts Statistical Analysis Tools, Techniques and SPC 9
A MSA (Measurement System Analysis) for Characteristics with One Tolerance Limit Capability, Accuracy and Stability - Processes, Machines, etc. 10
R Maximum Reverse Speed Limit for Powered Wheelchairs Other US Medical Device Regulations 2
N Protein content limit in condom according to ASTM standard Other ISO and International Standards and European Regulations 3
A Is there a time limit on customer claims? Quality Manager and Management Related Issues 8
M QC Limit Sample template wanted Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
I Shewhart Constants vs Central Limit Theorem in calculating Control Limits Statistical Analysis Tools, Techniques and SPC 18
P CCP Critical Limit and Corrective Action - Plastic Brush Parts Food Safety - ISO 22000, HACCP (21 CFR 120) 14
A Change Ratio [Guideline in Control Limit Update] Statistical Analysis Tools, Techniques and SPC 3
D Appropriate Statistical Methods to set up an Alert/Warning Limit Quality Assurance and Compliance Software Tools and Solutions 15
R Current Limit in IEC 60601 Dielectric Strength Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A How to set Wirebond Alarm Limit? Statistical Analysis Tools, Techniques and SPC 2
R How to understand the IEC 60601 50 ms limit? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
I Bioburden Count Question - Bioburden is above the alert limit >1 CFU/component avg. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J What is the time limit for an auditor to respond to NCR's and submit audit report? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
D Why a Lower Control Limit on Range and Sigma Statistical Analysis Tools, Techniques and SPC 7
D Hole Limit Dimension Values Placement - Smaller Limit On Top? Manufacturing and Related Processes 3
K Is there a "maximum time limit" for nonconformity to fix? Internal Auditing 11
S S-Type Tolerances: How to calculate Cs? Control Limit(s)? Statistical Analysis Tools, Techniques and SPC 8
K Calculating UCL (Upper Control Limit) and LCL (Lower Control Limit) Statistical Analysis Tools, Techniques and SPC 14
C 50 degrees C Temperature Limit for Patient Use Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S What's the maximum post limit in a day? Elsmar Cove Forum ToS and Forum Policies 6
R Windings Temperature exceeds the Limit - Overload Test of Switching Power Supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
O Capability with an Upper Limit but a Lower Limit which is Nominal Value Capability, Accuracy and Stability - Processes, Machines, etc. 4
V Considering a Time Limit for Document Approval Document Control Systems, Procedures, Forms and Templates 22
K How to establish critical limit for Critical Control Points (CCPs) Food Safety - ISO 22000, HACCP (21 CFR 120) 7

Similar threads

Top Bottom