The ISO 14155:2020 GCP Standard applies to clinical investigations of medical devices, including in vitro diagnostic medical devices, for the purpose of gathering clinical data to provide evidence of the safety and performance of the device.

ISO 14155

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ISO 14155 Clinical investigation of human medical devices — Good Clinical Practice

This international standard addresses good clinical practice for the design, management, recording and reporting of clinical investigations performed on humans to assess the safety and performance of medical devices for regulatory purposes. However, it does not apply to in vitro diagnostic medical devices.

This standard was developed by the technical committee of ISO ISO/TC 194. The second edition of ISO 14155 was published in February 2011. The third edition was released in July 2020.

Editing and proofreading

The first edition of ISO 14155-1 was published on February 15, 2003. The second revision of the standard was released in February 2011, the third revision and therefore the current version of the standard was released in July 2020, ISO 14155 :2020.

Main requirements of the standard

ISO 14155 adopts the structure in the following division:

  1. Reach
  2. normative references
  3. Terms and definitions
  4. ethical considerations
  5. Clinical investigation planning
  6. Clinical investigation conduct
  7. Suspension, termination and termination of clinical investigation
  8. Sponsor’s Responsibilities
  9. Principal Investigator Responsibilities

Assessment

The ISO 14155:2011 standard is an evaluable and therefore certifiable standard. The standard concerns good clinical practice and protocols for clinical investigations and medical device plans. The evaluation is carried out following protocols defined in this international standard.

Certification

Independent assessment bodies perform independent assessments following the auditing principles and practices and protocols of this International Standard.

History

Year Description
2003 ISO 14155-1 (1st Edition)
2011 ISO 14155 (2nd edition)
2020 ISO 14155 (3rd Edition)

See too

References

External Links

  • ISO 14155—Clinical investigation of human medical devices—Good clinical practice
  • ISO 14155:2020 – Clinical investigation of human medical devices — Good clinical practice
  • ISOTC 194—Biological and clinical evaluation of medical devices


Source: ISO 14155
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