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

This document provides requirements for the development, validation and routine control of moist heat sterilization 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 heat sterilization 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:

a) saturated steam sterilization in which air is removed by passive purging (gravity displacement principle);

b) saturated steam sterilization in which air is removed by active air removal (dynamic air removal, pre[1]vacuum/fractionated vacuum principle);

c) contained product sterilization in which heat transfer is achieved by steam or steam-air mixtures;

d) contained product sterilization in which heat transfer is achieved by water sprays;

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.

1.2 Exclusions

1.2.1 This document does not specify requirements for development, validation, and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE 1 See ISO 22442-1, ISO 22442-2 and ISO 22442-3.

NOTE 2 Specific regulations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

1.2.2 This document does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent.

1.2.3 This document does not detail a specified requirement for designating a medical device as “sterile.”

NOTE National or regional requirements can designate medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67.

1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of moist heat sterilization facilities.

NOTE There can be applicable national or regional regulations for operational safety