Reference details

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Reference
EN ISO 10993-7:2008/A1:2022
Title
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
Organisation
CEN
Publisher status in source
WithdrawnThis is the status recorded in the source, not a statement that this is the latest edition.
Source access
19 October 2026

Research and application

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Product research routes

  • Toys and childcare products

    Age, play function, foreseeable use and the distinction between toys and other products used by children.

  • Medical devices

    Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls.

Questions for the evidence file

  • Classification rationale
  • Age assessment
  • Material and component schedule
  • Foreseeable-use evaluation
  • Intended purpose
  • Risk management

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