Standards to use for Propylene Glycol Heat/Cooler Fluid in a Device

12 questions to ask before buying a QMS
Elsmar Forum Sponsor
Stijloor

Stijloor

Staff member
Super Moderator
#2
#2
Re: What Standards to use for Propylene Glycol heat/cooler Fluid in a device.

A Quick Bump!

Can someone help? Thank you very much!
 
Statistical Steven

Statistical Steven

Statistician
Staff member
Super Moderator
#3
#3
Re: What Standards to use for Propylene Glycol heat/cooler Fluid in a device.

Highground said:
Can Glycol be sterile and would ISO 10993 be a good start to test for bacteria?
Click to expand...
Not sure I understand the question. Would the Glycol come in contact with the patient or user? If it is in a sealed coil used to heat/cool a device it would not be to be sterile, but instead risk analysis would need to be performed on what happens if there is a leak. Or am I missing something?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
P Citing EN standards Other Medical Device Related Standards 6
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
N Harmonized Standards for MDR Certification EU Medical Device Regulations 6
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
D Imaging/Image Quality Standards Other Medical Device Related Standards 1
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
Govind Informational ISO COVID-19 response: freely available ISO standards Other ISO and International Standards and European Regulations 1
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 25
Richard Regalado Informational ISO makes available relevant BCMS standards free for online access Business Continuity & Resiliency Planning (BCRP) 5
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
A NB (Notified Body) Audit of Standards ISO 13485:2016 - Medical Device Quality Management Systems 3
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
P Static Electricity/Pacemaker - Standards for static electricity generation CE Marking (Conformité Européene) / CB Scheme 3
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 4
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
S IVF medical devices standards and test methods Medical Device and FDA Regulations and Standards News 4
M What are the standards for malls management? ISO 14001:2015 Specific Discussions 1
A Complaint alert levels - Industry standards pertaining to alert levels for complaints Customer Complaints 5
R MDR standards - which standards to comply with ? EU Medical Device Regulations 3
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
M MDR "Common Specifications" (CS) - If not standards, then what? EU Medical Device Regulations 5
L In house calibration - Our CMM's are outside certified can I use them to certify our standards General Measurement Device and Calibration Topics 4
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Industry Labelling Standards - non medical Manufacturing and Related Processes 0
J Medical device related standards or regulations - Disposed records log ISO 13485:2016 - Medical Device Quality Management Systems 2
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3
M Standards Subscription Service and Standards Tracking Service Pros and Cons? Other US Medical Device Regulations 3
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
Q Interpreting China Medical Device regulations/standards China Medical Device Regulations 1
M Informational US FDA – Modifications to the List of Recognized Standards, Recognition List Number: 052 Medical Device and FDA Regulations and Standards News 0
M EMC Directive and product safety standards CE Marking (Conformité Européene) / CB Scheme 1
M Referenced Standards and/or "State of the Art"? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Sidney Vianna Informational List of ISO Management System Standards Other ISO and International Standards and European Regulations 0
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
R Rationale for changes to ISO Standards Other Medical Device Related Standards 4
D IEC EN 61326 Dated Standards - Dated standards for test protocols CE Marking (Conformité Européene) / CB Scheme 3
M Microbiological Testing Lab - Layout & Standards Other Medical Device Regulations World-Wide 0
M Different procedure templates for different standards - We have two different management systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
DuncanGibbons Are there aerospace standards for the development and manufacture of euipment and tools? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
W ISO standards /Social Audit Franchise (Accredited & Non Accredited) Service Industry Specific Topics 6
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
S Standards for real time stability for medical devices Other Medical Device Related Standards 2
S Mammography standards or regulations for radiology software (no hardware)? Other Medical Device and Orthopedic Related Topics 0
E Standards Management Tool Quality Tools, Improvement and Analysis 1
DuncanGibbons To what extent are NASA standards applicable to commercial aviation? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
A MDRS Standards Harmonisation - copy of ISO 15223-1 EU Medical Device Regulations 3

Similar threads

Top Bottom