Understanding IEC 60601-2-68 requirements

karthika subramaniam

Starting to get Involved
#1
Can anyone help me out in understanding the standard IEC 60601-2-68 would be very helpful?

IEC 60601-2-68:2014 - Medical electrical equipment ? Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment - Edition 1.0

Thank you all!
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 
Thread starter Similar threads Forum Replies Date
P Understanding IEC 60601-1:2005, Clause 8.1 b) - Short Circuiting Double Insulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House Medical Device and FDA Regulations and Standards News 0
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
J Properly understanding SPC - Newbie SPC questions Statistical Analysis Tools, Techniques and SPC 29
S Understanding control chart and measurement capability Statistical Analysis Tools, Techniques and SPC 2
P Minitab Data Analysis - Understanding if a Process is in Control or Not Using Minitab Software 2
R Understanding a few points on ISO 9001's Design and Development Planning ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Understanding Cycle Time - Why the time of the other activities are left out Lean in Manufacturing and Service Industries 11
J Understanding ISO 9001:2015 - 10.3 Continual Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
J Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Root Cause Analysis - Is Insufficient Understanding an acceptable Root Cause? General Auditing Discussions 9
E Understanding of TS 16949 Clause 7.6.2 IATF 16949 - Automotive Quality Systems Standard 5
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Understanding the absolute uncertainty specification for a Fluke 5500A Measurement Uncertainty (MU) 3
N Understanding, Challenging & Approving Supplier Control Plans FMEA and Control Plans 7
M Definition Recommendations - Understanding "recommendations" and "recommended corrective action" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
S Understanding UDI (Unique Device Identification) Other US Medical Device Regulations 10
T Understanding USP <1112> Water Activity as applicable to Medical Devices Other Medical Device and Orthopedic Related Topics 4
K Understanding Risk Management Requirements according to AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S MIL-HDBK-217 - Understanding the various Environmental Conditions Reliability Analysis - Predictions, Testing and Standards 1
D What is your understanding or interpretation of TS16949 7.4.1.2 IATF 16949 - Automotive Quality Systems Standard 6
C Understanding the relationship between 62304 and the MDD ER IEC 62304 - Medical Device Software Life Cycle Processes 7
S Understanding Subgroup Size - Multi Cavity (Minitab) Statistical Analysis Tools, Techniques and SPC 4
R Understanding clause 15.4.2.1 d) of amendment 1:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Understanding accreditation, MoUs, certifications Other ISO and International Standards and European Regulations 28
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
M Understanding Versions of Collateral and Particular Standards IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S Understanding, Analysis and Monitoring Quality Defects on Composite Components Statistical Analysis Tools, Techniques and SPC 3
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
B Understanding why my CpK and PpK are low, and LCL Statistical Analysis Tools, Techniques and SPC 20
S Understanding Quality Objectives, Metrics and KPI ISO 13485:2016 - Medical Device Quality Management Systems 15
Q Beginner's Understanding - The Purpose and Applications of QMS/ISO Standards Philosophy, Gurus, Innovation and Evolution 12
Q Understanding Configuration Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
W Understanding PPAP Appearance Approval APQP and PPAP 22
V Understanding Automotive Coating for Seating Mechanism Components Manufacturing and Related Processes 1
M Understanding of Regression and ANOVA in Minitab Statistical Analysis Tools, Techniques and SPC 8
4 Understanding ILAC policy P14:12/2010 6.3 part a) General Measurement Device and Calibration Topics 28
H Understanding 8.2.3 M&M of Processes for our Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Understanding ISO 26262 Road Vehicle Functional Safety Other ISO and International Standards and European Regulations 2
arios Understanding adoption of a product to an existing Sterilization Cycle Other US Medical Device Regulations 1
M Learning ISO 13485 - Getting a better understanding of the requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
S Understanding FDA rules regarding MDDS Status and Clinical Trials 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Understanding Identification of Design in QSR 21 CRF Part 820.30 Design Control (f) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Understanding the general Philosophy with Complaints and CAPAs ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom