ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations

planB

Super Moderator
The "Special situations" listed in ISO 10993-7, section 4.3.6, are extensively justified in Annex F, also through risk-assessment. These risk-assessment considerations may support an approach to keep these special situations "special" and their associated limits unmodified.
 

planB

Super Moderator
Yes, keeping these limits unmodified also for infants/neonates is justified by Annex F - quote from section F.2.1:
[...] the life-saving nature of the therapy significantly alters the risk-benefit analysis. The exposure limits given are based on risks and benefits associated with less critical circumstances. Therefore, ISO 10993-17 allows for device benefit alterations in allowable limits on a case-by-case basis. In consequence, there is scope for relaxation of limits in life-threatening situations where it is not possible to meet the specified limits.
 
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