ISO 10993-1:2009 incorporating Risk Management published by ISO

R

RA Princess

Hi Everyone

I haven't posted for some time but just thought I would let you know that I have just noticed that ISO has published the revision to ISO 10993-1 Biological evaluation of medical devices - evaluation and testing within a risk management process.

Please be aware though that BSI have only recently published a 2009 version of ISO 10993-1. This contains the identical requirements text to the 2003 version and has only been updated to incorporate two informative annexes linking the standard to the relevent essential requirements of the Medical Device Directives.

I think that this is going to cause some confusion as we now have two different standards both labelled as 2009 versions. ISO 10993-1:2009 and BS EN ISO 10993-1:2009. It will be interesting to see what happens when BSI have to update their edition to incorporate the new risk management changes of the ISO 2009 version.

Leeanne
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
E Meeting ISO 10993-1 2009 Material Risk Assessment Requirements Other Medical Device Related Standards 13
I ISO 10993-1:2009 Sensitization (Initial Evaluation Test) vs. USP Other Medical Device Related Standards 3
R What the difference in ISO 10993-11:2006 and 2009? Other Medical Device Related Standards 17
M ISO 10993-5:2009 vs. ISO 10993-5:2003 differences - Cytotoxicity Testing Other Medical Device Related Standards 7
W ISO 10993-6 Implantation Other Medical Device Related Standards 1
Dirk S Contact duration (ISO 10993-1) vs. body contact days (ISO TS 21726) Other Medical Device Related Standards 2
S Microdermabrasion device - classification according to the ISO 10993-1 Other Medical Device Related Standards 1
D Is ISO 10993-1:2020 a Harmonized Standard? Other Medical Device Related Standards 3
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
L ISO 10993-18 vs ISO 18562-4 Other Medical Device Regulations World-Wide 4
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 5
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
M In Vitro irritation testing according to ISO 10993-23 ISO 13485:2016 - Medical Device Quality Management Systems 2
M Extractables testing replicates - Chemical Characterization ISO 10993-18 EU Medical Device Regulations 2
O ISO 10993 or ISO 18562? Other Medical Device Related Standards 1
Judy Abbott ISO 10993-18: 2020 extractables screening Other ISO and International Standards and European Regulations 2
V EN ISO 10993-1, Category of surface device by nature of body contact Other Medical Device Related Standards 2
Y ISO 10993-14:2001 - Gel implants stored in glass syringes Other Medical Device Related Standards 1
C Biologic Evaluation based on ISO 10993-1 EU Medical Device Regulations 2
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
R ISO 10993-18 Medical Device and FDA Regulations and Standards News 1
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 3
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 12
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
T ISO 10993-7 - Ethylene oxide sterilization residues Other Medical Device Related Standards 1
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
M Does ISO 10993 Apply to Packaging? (e.g. Travel Case) Other Medical Device Related Standards 4
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
T Using Risk Management in ISO 10993 - Medical Device Accessory 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P ISO 10993 - Sterile (Irradiation) Polypropylene Syringe Question Other Medical Device Related Standards 6
D Actual Definition of Non-Contact for ISO 10993 Other Medical Device Related Standards 1
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4
T Plastic of an infusion pump enclosure and ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 2
E Upcoming changes for ISO 10993 and IEC 60601 in South Korea Other Medical Device Regulations World-Wide 2
M FDA issues draft guidance to replace G95-1 (Application of ISO 10993) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Verify GB/T 16886 is the same as ISO 10993 US Food and Drug Administration (FDA) 5
B New ISO 10993-12 - Consistency of Extraction Conditions through different Assays Other ISO and International Standards and European Regulations 1
S Suppliers of ISO 10993 compliant Material for Skin Contact Other ISO and International Standards and European Regulations 3

Similar threads

Top Bottom