James Morrison


Gas Pathways – ISO 18562 progress

The ISO 18562 series of standards for Biocompatibility evaluation of breathing gas pathways in healthcare applications was initially published in 2017. These standards evaluate the safety of substances added to...

When is a Standard Actually a Standard?

Just because a document declares it is a standard, does not mean that it is universally acceptable. A standard (including an ISO standard) is just another interesting (and certainly well-intentioned)...
MRI Machine

MR Compatibility and Materials Science

Magnetic Resonance Imaging (MRI) is a well-established diagnostic technology. Since its introduction in the early 1980s, it has been widely used and extensively developed. It has many of the capabilities...

FDA & “Certain Devices” with Intact Skin Contact – Draft Guidance Assessment

The human body’s biggest organ is the skin. It is also our best organ because it keeps the outside out and our insides in. Yet, despite its remarkable toughness and...
Lab Testing

“How Irritating!” A new paradigm for irritation testing.

In January 2021, a new biocompatibility standard was published: ISO 10993-23 Biological evaluation of medical devices - Tests for irritation. This has been long-anticipated and is a very welcome event....

New Guidance on FDA ISO 10993-1

On 4 September 2020 FDA re-issued their guidance on the use of ISO 10993-1 and Biocompatibility. I don’t think anyone saw this coming. It’s a big surprise! But the good...
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Chemical Characterisation – no simple matter

Understanding Chemistry is now mandatory The most recent edition of ISO 10993-1 in 2018 added to the evaluation table (Table A.1) the interesting item “Physical and/or chemical information.” This is...

Inaugural Course on Molecular Toxicology

Molecular toxicology is the discipline that particularly emerged in recent years as a result of the paradigm shift currently going on in the field of toxicology. This shift is the...
Wringing out

On Extraction – the vagaries

In previous articles, some months ago on LinkedIn, I discussed the process of extraction. That is the process of preparing a sample for testing (perhaps biological) from a test article...

TC194 Wrap Up 2018

TC194 – The Big Wrap The ISO Technical Committee 194 is responsible for the biological and clinical evaluation of medical devices. The Annual meeting of TC194 was recently conducted in...


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