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Evidence

Six peer-reviewed studies.
Three of them in The Lancet.

We did not commission most of this literature — it belongs to the material. What we add is a weave that holds wool at a medical density, so the material behaves the way the studies describe.

CE Class I
EU MDR 2017/745

Documentation review by ICR Polska, valid to 27 Jun 2028. Class I, non-sterile — self-declared with technical file assessment.

AS 4480.1
Medical sheepskin

Australian standard for medical sheepskins, AS 4480.1-1998. Our material is specified to exceed it.

Bureau Veritas
Formaldehyde: not detected

Report (9323)149-0234-R1, tested to DIN EN ISO 14184-1:2011. Result ND, limit of detection 16 mg/kg.

HeiQ
Antimicrobial finish

Tested per HeiQ LS23-04475. Activity maintained after repeated washing against S. aureus.

Literature

Published research

01
“How do microclimate factors affect the risk for superficial pressure ulcers: a mathematical modeling study”Gefen, A. — 2011
Journal of Tissue Viability
20, 81–88
02
“The effect of wool bedding on sleep”Dickson, P. R. — 1984
Medical Journal of Australia
140, 87–89
03
“Evaluation of quality of life in fibromyalgia patients using wool bedding”Kiyak, E. et al. — 2009
Australian Journal of Advanced Nursing
26, 47–52
04
“Care of jaundiced infants with sheepskin”Powley, M. et al. — 1980
The Lancet
315, 979–980
05
“Weight gain and movement patterns in very low birth weight infants nursed on wool bedding”Scott, S. et al. — 1983
The Lancet
322, 1014–1016
06
“Nursing low birth weight infants on wool”Scott, S. & Richards, M. — 1979
The Lancet
313, 1028
1980
“The use of sheepskin in the care of low birth weight infants was associated with improved weight gain and calmer movement patterns.”
Scott, S. et al. — The Lancet, 1983
Compliance statement

What we claim,
and what we don't.

Our material is a CE Class I medical device under EU MDR 2017/745, non-sterile. The classification is self-declared with a technical documentation review by ICR Polska (certificate ICR Polska/DR/HM230674, valid to 27 June 2028). It is not a Notified Body assessment.

Formaldehyde content was tested by Bureau Veritas to DIN EN ISO 14184-1:2011 and reported as not detected, with a limit of detection of 16 mg/kg.

We publish the literature because it exists, not because it proves a specific outcome for every user. Medical decisions about pressure injury prevention should be made with a clinician.

Pressure relief seat cushion

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