BS EN ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

NOTE 1 Although the scope of BS EN ISO 11135-1:2007 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products.

Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

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

BS EN ISO 11135-1:2007 does not detail a specified requirement for designating a medical device as sterile.

NOTE 3 Attention is drawn to national or regional requirements for designating medical devices as sterile. See for example EN 556-1 or ANSI/AAMI ST67.

BS EN ISO 11135-1:2007 does not specify a quality management system for the control of all stages of production of medical devices.

NOTE 4 The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this part of ISO 11135 to have a complete quality management system during manufacture or reprocessing, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see in particular Clause 4). National and/or regional regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.

BS EN ISO 11135-1:2007 does not specify requirements for occupational safety associated with the design and operation of ethylene oxide sterilization facilities.

NOTE 5 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist.

NOTE 6 Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling ethylene oxide and for premises in which it is used.

BS EN ISO 11135-1:2007 does not cover sterilization by injecting ethylene oxide or mixtures containing ethylene oxide directly into individual product packages, or continuous sterilization processes.

BS EN ISO 11135-1:2007 does not cover analytical methods for determining levels of residual ethylene oxide and/or its reaction products.

NOTE 7 For further information see ISO 10993-7.

NOTE 8 Attention is drawn to the possible existence of regulations specifying limits for the level of ethylene oxide residues present on or in medical devices and products. This standard is identical to ISO 11135-1:2007



Cross References:
ISO 10012
ISO 10993-1
ISO 10993-7
ISO 11138-1:2006
ISO 11138-2:2006
ISO 11140-1
ISO 11737-1
ISO 11737-2
ISO 13485:2003
ISO 14161
ISO 14937:2000
ISO 9000:2005
ISO 9001
ISO/TS 11139:2006
ISO 11607-1
ISO 11607-2
ISO 14001
ISO 14040
ISO 14971
ISO 17664
ISO 22442-1
ISO 22442-2
ISO 22442-3
ISO/IEC 90003
IEC 61010-1
IEC 61010-2-040
ANSI/AAMI ST67
AAMI TIR16
94/9/EC
EN 556-1
VIM:1993
90/385/EEC
93/42/EEC
98/79/EEC


Replaces BS EN 550:1994 which remains current.