ISO10993 - Biocompatibility in medical vacuum systems (vacuum pumps)

Oneves

Starting to get Involved
#1
ISO10993 - Biocompatibility in medical vacuum systems (vacuum pumps)

Dear all
can anyone help me with this?

Since vacuum is empty of matter (there is no material), it is a negative pression, how is biocompatibility applicable?
 
Elsmar Forum Sponsor

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#2
ISO10993 - Biocompatibility in medical vacuum systems (vacuum pumps)

Dear all
can anyone help me with this?

Since vacuum is empty of matter (there is no material), it is a negative pression, how is biocompatibility applicable?
5.2.1 Non-contacting medical devices These include medical devices (or components) that have neither direct nor indirect contact with the body and where biocompatibility information would not be necessary. Diagnostic software, an in vitro diagnostic device and a blood-collection tube are examples of non-contact devices

I am not sure one can simply state "We dont need to do this testing" and be done. Modern medical device QMS are based on a risk based approach. I might suggest a risk review where an analysis of the device in use has no human body contact.
 
Last edited:
Thread starter Similar threads Forum Replies Date
H ISO10993 Requirements for Accessories Other ISO and International Standards and European Regulations 2
B Expert advice on in vitro cytotoxicity test ISO10993-5 Other Medical Device Related Standards 1
I Testing compliant to USP Class VI and ISO10993-1 compliant. Is that possible? Food Safety - ISO 22000, HACCP (21 CFR 120) 10
J Biocompatibility for endoscope external handle/grip US Food and Drug Administration (FDA) 3
S Validity of biocompatibility reports ISO 13485:2016 - Medical Device Quality Management Systems 4
E Biocompatibility testing of our applied part seems redundant Other Medical Device Related Standards 2
S Biocompatibility requirement for electrode adapters Other Medical Device Related Standards 1
S ASTM F86 x Biocompatibility Issues Medical Device and FDA Regulations and Standards News 1
Judy Abbott The impact of laser power on biocompatibility of the products Manufacturing and Related Processes 6
Watchcat Summary of De Novo Biocompatibility Information, 2015-2018 Other US Medical Device Regulations 0
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A How much does a complete biocompatibility test package cost? Other ISO and International Standards and European Regulations 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 13
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
K Biocompatibility evaluation of gas pathways Medical Device and FDA Regulations and Standards News 5
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
Judy Abbott Activation of complement at 90 min - BSI requested for justifications to support the biocompatibility of the device EU Medical Device Regulations 2
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
shimonv Referring to previously submitted biocompatibility results in a new 510(k) submission Other US Medical Device Regulations 1
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
R 510(k) Biocompatibility vs Cleaning Validation Other Medical Device Related Standards 4
K Biocompatibility classification for Lancet CE Marking (Conformité Européene) / CB Scheme 7
F Sample Size for Biocompatibility Tests Other Medical Device Related Standards 4
F Biocompatibility Device Categorization: Priming with Blood Other Medical Device Related Standards 1
W Biocompatibility Risk Analysis for Clinical Practitioner 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F Biocompatibility on aged devices Other Medical Device Related Standards 4
Gamula Biocompatibility GLP conform tests outside China China Medical Device Regulations 1
K Biocompatibility Testing - Component Level or Assembled Medical Device? ISO 13485:2016 - Medical Device Quality Management Systems 7
I Biocompatibility Impact on Autoclaved Silicone Other Medical Device Related Standards 3
D Should Biocompatibility Tests be performed on Production Samples? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R What is the expectation for Biocompatibility Testing when switching Suppliers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
C Biocompatibility Test for a Non Contact Medical Device US Food and Drug Administration (FDA) 11
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4
planB Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance Other Medical Device Related Standards 1
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4
M Biocompatibility - why are animal studies necessary? Other Medical Device and Orthopedic Related Topics 11
R Biocompatibility Test of Blue Gown vs Blue Drape 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R FDA Biocompatibility questions for Surgical Gown 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Biocompatibility requirements for a Class IIa medical device CE Marking (Conformité Européene) / CB Scheme 7
S Biocompatibility testing for nasal prongs made of medical grade silicone 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
J Biocompatibility tests in AAA LAC Laboratory ISO 13485:2016 - Medical Device Quality Management Systems 6
B Biocompatibility for Packaging Materials Other Medical Device Related Standards 3
J Biocompatibility Evaluation component other than Testing Other Medical Device Regulations World-Wide 1
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3
S Laminaria - Is a Biocompatibility Study Required? EU Medical Device Regulations 6

Similar threads

Top Bottom