ISO/TR 20416:2020-07

Inhalt (en)

• Foreword
• Introduction
• Scope
• Normative references
• Terms and definitions
• Purpose of post-market surveillance process
• Planning of post-market surveillance Unterkapitel anzeigen Unterkapitel ausblenden

  • General
  • Scope of the post-market surveillance plan
  • Objective of the post-market surveillance plan
  • Responsibilities and authorities
  • Data collection Unterkapitel anzeigen Unterkapitel ausblenden

    • Data sources
    • Defining data collection methods
    • Developing the data collection protocol
  • Data analysis Unterkapitel anzeigen Unterkapitel ausblenden

    • General
    • Considerations concerning planning the data analysis
    • Methods for data analysis
  • Report on data analysis
  • Interface with other processes
• Review of the post-market surveillance plan Unterkapitel anzeigen Unterkapitel ausblenden

  • Purpose of the review
  • Criteria
  • Review
• Examples of data sources (informative)
• Examples of data analysis methods (informative) Unterkapitel anzeigen Unterkapitel ausblenden

  • General
  • Overview table: data analysis methods
  • Descriptive methods for trend analysis
  • Descriptive method: Bar charts
  • Descriptive method, Pareto analysis
  • Qualitative techniques
• Examples of post-market surveillance plans (informative) Unterkapitel anzeigen Unterkapitel ausblenden

  • Example of a post-market surveillance plan for a surgical scalpel Unterkapitel anzeigen Unterkapitel ausblenden

    • General
    • Scope of the post-market surveillance plan
    • Objective of the post-market surveillance plan
    • Responsibilities and authorities
    • Data collection
    • Data analysis
    • Report on data analysis
    • Review of the post-market surveillance plan
  • Example of a post-market surveillance plan for a radiation therapy system Unterkapitel anzeigen Unterkapitel ausblenden

    • General
    • Scope of the post-market surveillance plan
    • Objective of the post-market surveillance plan
    • Responsibilities and authorities
    • Data collection
    • Data analysis
    • Report on data analysis
    • Review of the post-market surveillance plan
  • Example of a post-market surveillance plan for a drug eluting stent Unterkapitel anzeigen Unterkapitel ausblenden

    • General
    • Scope of the post-market surveillance plan
    • Objective of the post-market surveillance plan
    • Responsibilities and authorities
    • Data collection Unterkapitel anzeigen Unterkapitel ausblenden

      • Passive/reactive feedback
      • Proactive feedback
    • Data analysis Unterkapitel anzeigen Unterkapitel ausblenden

      • General
      • Post-market clinical follow-up studies
    • Report on data analysis
    • Review of the post-market surveillance plan
  • Example of a post-market surveillance plan for a blood glucose monitoring system Unterkapitel anzeigen Unterkapitel ausblenden

    • General
    • Scope of the post-market surveillance plan
    • Objective of the post-market surveillance plan
    • Responsibilities and authorities
    • Data collection
    • Data analysis
    • Report on data analysis
    • Review of the post-market surveillance plan
  • Example for large IVD analyser Unterkapitel anzeigen Unterkapitel ausblenden

    • General
    • Scope of the post-market surveillance plan
    • Objective of the post-market surveillance plan
    • Responsibilities and authorities
    • Data collection
    • Data analysis
    • Report on data analysis
    • Review of the post-market surveillance plan
• Bibliography