Manufacturers must understand the implications of the 2014 update to ISO 11135 on the sterilisation of medical devices using ethylene oxide
A new paper written by Haroon Atchia identifies and assesses the changes introduced by ISO 11135:2014
London, 7 January 2015
Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written an article on the changes to ISO 11135 on the sterilisation of medical devices by exposure to ethylene oxide.
The paper entitled “Critical examination of changes to ISO 11135 on sterilisation of medical devices by exposure to ethylene oxide” examines the standard in an attempt to understand the implications for medical device manufacturers currently using ISO 11135-1:2007 and those seeking to apply ISO 11135 for the first time.
“When a new standard or edition of an existing standard is published, it is not uncommon for this to create questions on changes and implications but it is not always easy or efficient to understand such factors because of daily demands. Therefore, I hope that this work can assist the reader in the daily application of the new standard and also prompt some fundamental questions that the standard does not seem to answer, so could be considered in the future.”, says H Atchia.
The English language article of 38 pages is available at
RRP: £80 (plus VAT, as applicable).
About Quality First International (QFI)
QFI is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.