Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

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1   Scope

This document provides requirements for the development, validation and routine control of moist heatsterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heatsterilization processes according to this document. The application within industrial and health care settings is considered.

1.1   Inclusions

Moist heat sterilization processes covered by this document include, but are not limited to:
  1. a) saturated steam sterilization in which air is removed by passive purging (gravity displacement principle);
  2. b) saturated steam sterilization in which air is removed by active air removal (dynamic air removal, pre-vacuum/fractionated vacuum principle);
  3. c) contained product sterilization in which heat transfer is achieved by steam or steam-air mixtures;
  4. d) contained product sterilization in which heat transfer is achieved by water sprays;
  5. e) contained product sterilization in which heat transfer is achieved by water immersion.

NOTE 1 See Annex D where the processes are explained further.

NOTE 2 Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products and industrial applications.