JIS T 1115 Comparison (Japan Medical Device Standard)

QM Becky

Involved In Discussions
#1
Hi All,
I am stumped at the moment regarding a Japanese standard (specifically JIS T 1115) but the question is generic in case you aren't familiar with that particular standard.

With respect to the Japanese standards, does anyone know of a good site or collection of data comparing the Japanese standards with their closest IEC or ISO or ANSI/AAMI etc standards? We have a clinical validation to an IEC standard and our Japanese partners are asking for the JIS compliant version of our validation. SO, I am trying to confirm if the IEC standard is the same as or what are the differences.

Anyone?

Thank you!
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
GoKats78 ASME Y14.5 Dimensioning and Tolerancing - Is there a JIS equivalent to Y14.5? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
M Informational EC – Guide for referencing standards in public procurement in Europe (JIS Action 11) Medical Device and FDA Regulations and Standards News 0
P JIS T 0601-1:2014 Transition Date IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels Japan Medical Device Regulations 2
V Test Lab for JIS T 1501 (Performance of Ultrasonic Pulse-Echo Diagnostic Equipment) Japan Medical Device Regulations 1
M Infusion Pumps Japan - JIS T 0601-2-24 Japan Medical Device Regulations 5
R Can some one share JIS B7502/7507 or DIN862 with me for study purpose? General Measurement Device and Calibration Topics 2
S Surface Finish - Conversion factor to transform Rz Jis in Rz Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
R JIS B 7502, B7507 - what are these standards and where/how to use them? General Measurement Device and Calibration Topics 2
F Spring Steel Wires - JIS 3560, DIN 17223 & SAE 9254 (JIS G 3561) Manufacturing and Related Processes 2
Chennaiite English version of the JIS D5707 Standard - Where to buy Other ISO and International Standards and European Regulations 1
P Where to find JIS (Japan) Standards Various Other Specifications, Standards, and related Requirements 6
J Mechanical Properties Standard for S45C (JIS / ASTM / ANSI / ISO) General Measurement Device and Calibration Topics 4
D Bolt Size per Standard - JIS standard and the ISO standard on thread size Other ISO and International Standards and European Regulations 7
Q Capability - CPk comparison values Capability, Accuracy and Stability - Processes, Machines, etc. 8
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 0
T Interlaboratory comparison or proficiency testing in destructive testing of welded joints ISO 17025 related Discussions 2
F Measurement Audit and ILC for ISO 17025 Clause 7.7.2 - Comparison with results of other laboratories ISO 17025 related Discussions 0
K Comparison essential requirements EU compared to those of MDSAP countries Other Medical Device Regulations World-Wide 3
L Comparison matrix between IATF 16949:2016 to ISO 12207, ISO 9001 and Automotive SPICE IATF 16949 - Automotive Quality Systems Standard 3
P ISO 15378 2015 to 2017 Comparison wanted General Auditing Discussions 4
E 2 participants in inter-laboratory comparison tests ISO 17025 related Discussions 3
T MDD and IVD comparison Other Medical Device Regulations World-Wide 2
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Machinery Directive vs. MDD Comparison Matrix wanted EU Medical Device Regulations 6
T Automated and Manual Measurement System Comparison (Correlation) Quality Tools, Improvement and Analysis 3
A ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO9001:2015 comparison with AS9100:2016 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Comparison of ISO 9001:2008 and CAN3-Z299.3 Other ISO and International Standards and European Regulations 1
C Checklist comparison between ISO9001:2008 and ISO 3834 Quality Management System (QMS) Manuals 1
N Digital vs Dial Caliper Comparison Measurement Uncertainty (MU) 17
P Comparison of OEDC and US FDA GLP (Good Laboratory Practices) Other Medical Device and Orthopedic Related Topics 4
P Alternative To PT/ILC (Inter-Laboratory Comparison) Requirement General Measurement Device and Calibration Topics 3
ncwalker Ranking Criteria Systematically - Pairwise Comparison.xlsm Lean in Manufacturing and Service Industries 7
C What is "Participation in interlaboratory comparison or proficiency-testing programs" General Measurement Device and Calibration Topics 8
G Comparison Study of CMMs and software along with Probe Types Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
F Comparison of 2 CMM machines using Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
M SAE AS 9101 Rev D and E Comparison wanted - March 2014 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
S ISO 9001:2008 / ISO TS16949:2009 Comparison ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q ISO 9001:2008 & 2015 comparison ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C How to determine a sample size for comparison purposes ? Quality Tools, Improvement and Analysis 2
S Comparison between Rapapport Vassilliadis Broth and Selenite Broth for Salmonella Food Safety - ISO 22000, HACCP (21 CFR 120) 1
M CMDR vs. MDD Comparison Canada Medical Device Regulations 3
L Australia/Canada and USA v's EU Medical Devices Regulations Comparison Other Medical Device Regulations World-Wide 4
S Method Comparison Design Onput Sample Range Requirement Design and Development of Products and Processes 3
S Comparison between Microgen A+B,API 24e and microbact 24e US Food and Drug Administration (FDA) 1
F Statistical Comparison of Product: High Average vs. Low Range Capability, Accuracy and Stability - Processes, Machines, etc. 13
M Comparison between TS 16949 clauses 8.5.2 and 8.5.2.1 IATF 16949 - Automotive Quality Systems Standard 6
J Comparison table between ISO 20000 and ISO 9001 IT (Information Technology) Service Management 7
P GMP or quality system "requirement" comparison for different sector Various Other Specifications, Standards, and related Requirements 1
Similar threads


















































Top Bottom