Reference details

Open the official standard record
Reference
EN ISO 11137-1:2015
Title
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
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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  • Medical devices

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

Questions for the evidence file

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  • Classification rationale
  • Risk management
  • Verification and performance evidence
  • Clinical evidence scope

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Legislation reference records

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Other indexed references in this family

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