Upcoming changes for ISO 10993 and IEC 60601 in South Korea

edgar123

Starting to get Involved
#1
The following changes are on-going in South Korea:

  • Implementation of biocompatibility standards, following the revisions of ISO 10993-4,9,13,16.
  • Implementation of IEC 60601-1 3rd Ed.
Both changes are currently under public consultation.
The due dates for the consultation are respectively Mar. 31, and Feb. 28, 2014.


I thought some people might be interested to know...
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Marc 9 September 2018 - Upcoming User Group Changes Forum News and General Information 1
B Upcoming Changes to RABQSA Lead Auditor Certifications Professional Certifications and Degrees 3
J Ignoring a Failed Gage R&R and upcoming external audit IATF 16949 - Automotive Quality Systems Standard 22
John Broomfield Informational Upcoming vote on the kilogram - November 2018 General Measurement Device and Calibration Topics 5
K No Internal Audits For Upcoming IATF Trans Audit IATF 16949 - Automotive Quality Systems Standard 5
Brizilla Knowledge of the upcoming ISO 17025 Revision ISO 17025 related Discussions 5
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
Marc Upcoming MacOS - Sierra - 2016 After Work and Weekend Discussion Topics 0
O Upcoming IEC/ISO standard on "Distributed alarm systems" (80001-2-5) Medical Information Technology, Medical Software and Health Informatics 6
Sidney Vianna ISO 17023 - Upcoming Standard for Determining Audit Time by CB's Registrars and Notified Bodies 1
Q Upcoming ISO13485 Audit from the parent NB (Notified Body) Quality Manager and Management Related Issues 14
G Need help in an upcoming ISO 13485 Audit ISO 13485:2016 - Medical Device Quality Management Systems 7
T Current and upcoming events (coffee break topic) Coffee Break and Water Cooler Discussions 4
S Outdated Document Control Procedure & Upcoming Audit Document Control Systems, Procedures, Forms and Templates 7
BradM NCSLI this upcoming week! Who will be there? July 2010 General Measurement Device and Calibration Topics 11
Miner Upcoming article - Within-part variation when performing an R&R Imported Legacy Blogs 6
Q Upcoming FAA Audit - What to expect (subtier for a Repair station)? Federal Aviation Administration (FAA) Standards and Requirements 5
J Advice for Upcoming Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Hershal NCSLI this upcoming week! Who will be there?-2009 General Measurement Device and Calibration Topics 8
D Upcoming FDA ISO 13485 audit guidance (draft version) ISO 13485:2016 - Medical Device Quality Management Systems 19
RoxaneB How to Handle Emotional Bias during Upcoming Audit? Internal Auditing 12
G "Inspection Culture " to "Quality Assurance Culture" - Upcoming Job Interview Career and Occupation Discussions 15
K Employee Training For Upcoming ISO 9001 Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Need Advise on upcoming ISO 9001:2000 Surveillance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
CarolX Upcoming Article in "Quality" on gage management General Measurement Device and Calibration Topics 2
C Need Direction on Process Flowchart for our upcoming ISO 9001:2001 audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
A Calculator for ASQ Exams - I can't use my TI-86 calculator for upcoming ASQ exams! Professional Certifications and Degrees 3
N What will change in the upcoming update of ISO 14001? ISO 14001:2015 Specific Discussions 5
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
F Medical devices_hong kong_post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
NDesouza When Customers Make Changes to Orders Contract Review Process 24
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 2
R What are the changes in 5th Edition of FMEA manual? FMEA and Control Plans 6
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
M What are the changes in supervising according to ISO17025? ISO 17025 related Discussions 7
U Changes to Internal Processes and Risk Evaluation - Mitigations Risk Management Principles and Generic Guidelines 10
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
R Rationale for changes to ISO Standards Other Medical Device Related Standards 4

Similar threads

Top Bottom