Medical devices and health care products sterilisation


28 April 2010

Clinical investigation of medical devices for human subjects – General requirements BS EN ISO 14155-1:2009 defines the procedures for the conduct and performance of clinical investigations of medical devices, where their clinical performance and safety is being assessed. The Standard is intended to protect people and to ensure the scientific conduct of the clinical investigation.

BS EN ISO 14155-1:2009 specifies:

  • requirements for the organisation, conduct, monitoring, data collection, and documentation of the clinical investigation
  • requirements that establish the performance of the device under conditions intended to mimic normal clinical use, thereby revealing adverse events in normal use and allowing the assessment of acceptable risks.

Sterilization of health care products – Biological indicators – Guidance for the selection, use and interpretation of results ISO 14161:2009 includes guidance for the selection, use, and interpretation of results from the application of biological indicators when used in the development, validation, and routine monitoring of sterilisation processes. ISO 14161:2009 applies to biological indicators for which Standards exist (for example, in the ISO 11138 series).

The information provided in ISO 14161:2009 can have useful application for processes and biological indicators not currently addressed by existing Standards, for example, new and developing sterilisation processes.

In ISO 14161:2009 users will find guidance on selection of the correct biological indicator for their particular sterilisation process and critical parameters as well as guidance on its appropriate use.

Order BS EN ISO 14155-1:2009, ISO 14161:2009, or the ISO 11138 Standards from (enter '14155-1' or '11138' and select ISO), email, or call 0800 782 632. To order PDFs of BS and ISO Standards email or call 0800 782 632 during business hours.

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