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References & evidence

Operational results, validation and regulation, clearly separated

Customer references, laboratory evidence, conformity records and regulatory sources are presented with a clear source and scope.

Operational and programme evidence

Sterilwave in practice

A hospital reference, an independent programme evaluation and a European assessment make performance and implementation conditions tangible.

The Netherlands

UMC Utrecht

UMC Utrecht uses Sterilwave as part of a broader approach to processing infectious clinical waste and demonstrates its operational and quantitative value.

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Senegal

Hazardous-waste programme

1,959 kg in 224 cycles

An independent UNIDO evaluation documents operation of Sterilwave 100 in Tivaouane and also identifies training and continuity as critical success factors.

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European Union

Green Assist assessment

Environmental and circular assessment

CINEA documents support for environmental-benefit assessment, DNSH and possible reuse routes for treated Sterilwave residue.

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SimpleComply in the Benelux

International evidence, applied locally

SimpleComply translates Sterilwave evidence into the actual waste stream, site conditions, permits, validation, business case and daily operation of each organisation.

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Independent validation

Evidence by question type

A certificate, laboratory test and operational reference do not prove the same thing.

Microbiology

IRM test series

NF X 30-503 tests report 7.41 to 8.68 log10 reduction. Four regrowth tests recorded 0 CFU/g through day 28.

Emission measurement

SGS, UMC Utrecht

Report EZEM-2021-08-00009 documents off-gas measurements before and after HEPA and carbon filtration.

Site validation

Whipps Cross

Report 16/0691 records more than 4 log10 inactivation in all tested samples, consistent with STAATT Level III.

Quality assurance

Conformity and certification

Model-specific conformity records and ISO certifications support quality management but are not stand-alone microbiological evidence.

6 log1099.9999% reduction under the test conditions
8 log1099.999999% reduction under the test conditions

Each additional log step is a further tenfold reduction. Log values are test results, not a blanket guarantee for every waste stream or site.

Regulatory & European evidence

Approval and programme assessment

France

Interministerial circular

Circular DGS/EA1/DGPR/2012-335 addresses Sterilwave for pre-treatment by decontamination of infectious healthcare waste, with technical requirements and excluded streams.

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Europe

Green Assist assessment

CINEA describes support for assessing environmental benefits, DNSH and potential reuse routes for treated residue under European environmental conditions.

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Application note: Applicability and waste acceptance remain dependent on country, waste stream, model and site conditions.

Next step

Need a site-specific evidence file?

SimpleComply translates the available evidence into your acceptance matrix, validation plan, permit strategy, business case and implementation requirements.

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