EN ISO 11135-1 pdf download

EN ISO 11135-1 pdf download Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
This part of ISO 11135 does not cover analytical methods for determining levels of residual ethylene oxideand/or its reaction products.
NOTE 7For further information see ISO 10993-7
NOTE 8Attention is drawn to the possible existence of regulations specifying limits for the level of ethylene oxideresidues present on or in medical devices and products
2Normative references
The following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.
ISO 10012 Measurement management systems– Requirements for measurement processes and measuringequipment
ISO 10993-1, Biological evaluation of medical devices 一 Part 1: Evaluation and testing
ISO 10993-7, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
ISO 11138-1:2006，Sterlization of health care products – Biological indicators- Part 1: Generalrequirements
ISO 11138-2:2006,Sterilization of health care products — Biological indicators – Part 2: Biological indicatorsfor ethylene oxide sterilization processes
SO 11140-1, Sterilization of health care products — Chemical indicators 一 Part 1: General requirements
ISO 11737-1, Sterilization of medical devices – Microbiological methods – Part 1: Determination of a populationof microorganisms on products
SO 11737-2, Sterlization of medical devices — Microbiological methods – Part 2: Tests of sterility performed irthe validation ofa steriization process
SO 13485:2003, Medical devices 一 Quality management systems 一 Requirements for regulatory purposes
ISO 14161, Sterilization of health care products – Biological indicators — Guidance for the selection, use andinterpretation of results
SO 14937:2000 Sterilization of health care products — General reguirements for characterization of asterlizing agent and the development, validation and routine control of a sterilization process for medicadevices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.3.1
aeration
part of the sterilization process during which ethylene oxide and/or its reaction products desorb from themedical device until predetermined levels are reached
NOTEThis may be performed within the sterilizer and/or in a separate chamber or room.
3.2
aeration area
either a chamber or a room in which aeration occurs
3.3
bioburden
population of viable microorganisms on or in the product and/or sterile barrier system
[ISO/TS 11139:2006, definition 2.2]
3.4
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[ISO/TS 11139:2006, definition 2.3]