SBS - The Best Value in QMS software

Tip test 10° -> 5°

#1
Hello,
i have a question about the Clause 9.4.2.1 tip test:
If the 10° inclines fails, is it okay to add a warning label if the 5° incline is passed? Cause 9.4.2.1 says prepare the cart as in 9.4.2.2 described.
And in 9.4.2.2 is in the last paragraph: "5° with warning label is okay"

Or must the 10° incline anyways be passed?

Thanks for your help!
KR
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Super Moderator
#2
There should be at least one "transport position" (configuration) that passes the 10° test, for example if the device is on a pole with adjustable height, the warning label + instruction (label or IFU) might say for transport, move to the lowest position. This position must then pass the 10° test. The other positions only need to pass the 5° test.

Of course it is best and common to go for the 10° test in all configurations, that way no label/warning/instruction is needed.
 
Thread starter Similar threads Forum Replies Date
bobdoering Handy training tip for SPC - the Check Engine Light Analogy Statistical Analysis Tools, Techniques and SPC 0
Wes Bucey The "Informational Interview" - a job hunt tip? Career and Occupation Discussions 2
R Tip Load Testing Information Reliability Analysis - Predictions, Testing and Standards 2
G Effects of CMM Probe Tip Ball Size measuring a Round Part OD - CMM Help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 18
A Biocompatibility study necessary? Polycarbonate tip wrench tool Other Medical Device and Orthopedic Related Topics 6
D An important travel tip Imported Legacy Blogs 4
D In the Crosshairs - Stating that the tip of the crosshair is to be used for measuring Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
apestate CMM probe tip qualification -- why do it? General Measurement Device and Calibration Topics 20
D Tip of the hat IATF 16949 - Automotive Quality Systems Standard 23
shimonv Test Method Validation ISO 13485:2016 - Medical Device Quality Management Systems 9
C Test compulsory for Sutures? Manufacturing and Related Processes 6
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 0
K Identification test in ph.eur. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
AllTheThings ISO-17025 accredited TEST lab performing internal calibrations (Yes: Here is how) ISO 17025 related Discussions 6
R Cost per test tool/formula Oil and Gas Industry Standards and Regulations 1
R Cost per test tool/formula Oil and Gas Industry Standards and Regulations 1
A R chart from ANOVA gage R&R test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
K Ground Bond Test for Class I Medical Electrical Equipment - calibration problems IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Burst Test Acceptability Criteria ISO 13485:2016 - Medical Device Quality Management Systems 2
A 60601-1 clause 8.11.3.6 Test Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
E Tensile test machine, tinius olsen 602 Manufacturing and Related Processes 1
M Test failure Root cause not found Customer Complaints 10
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
M Sponsor name presented in the test report EU Medical Device Regulations 4
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 1
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Shelf Life Test for IFU and Implant Card Other Medical Device Related Standards 1
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Non parametric test for semi-quantitative data. Statistical Analysis Tools, Techniques and SPC 5
Ed Panek Disaster Recovery Test IT (Information Technology) Service Management 3
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Z Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices? Other Medical Device Related Standards 0
E When to perform accelerated aging studies and transport test(OQ or PQ) Qualification and Validation (including 21 CFR Part 11) 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
A Test requirements for marketing in US when RATED values are not of US IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
H Secondary Circuits, Voltage Test and Clearance/Creepage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Fogging test as per DIN 75201(50ug/g ) VDA Standards - Germany's Automotive Standards 3
R HV Test of HF Surgical Unit IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E 60950-1 resistance to abnormal heat test Various Other Specifications, Standards, and related Requirements 0
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4

Similar threads

Top Bottom