An overview of sterilizer equipment standards current and planned Richard Bancroft Science & Technical Director STERIS #deconevent2018
An Overview of Sterilization & Equipment Standards Current & Planned Richard Bancroft, B.Sc (Hons), FRSB Science & Technical Director STERIS Corporation Registered Authorising Engineer (Decontamination) Convenor, ISO/TC 198 WG 6 Convenor, CEN/TC 102 WG 7 Cochair, AAMI ST/WG 06
Equipment & Process Standards Equipment standard STANDARDS FOR DECONTAMINATION Supporting standards Process standard
High Temperature Sterilization Standards Equipment standard EN 13060 Equipment standard EN 285 STEAM Process standard EN ISO 17665
Low Temperature Sterilization Equipment standard EN 1422 Standards Equipment standard EN 17180 Equipment standard EN 14180 EO VHP FORM Process standard EN ISO 11135 Process standard EN ISO 14937 Or ISO 22441 Process standard EN ISO 25454
High Temperature Equipment Standards EN 13060 EN 13060 Sterilization. Steam sterilizers. Small Sterilizers EN 285 EN 285 Sterilization. Steam sterilizers. Large Sterilizers
EN 13060 Small Steam sterilizers EN 13060 first published in 2004 Latest version published in November 2014 Revised to align with machinery directive in Europe Small sterilizers differ from large porous load sterilizers (EN 285) in: size (less than 54 litres) Performance low steam supply capacity small vacuum pumps Minor amendment underway to correct text confusion regarding allowance of 134 C 138 C with older sterilizers versus 134 C- 137 C with 2014 version
EN 285 Large Steam Sterilizers EN 285 first published in 1996; major revision in 2006 Two amendments to 2006 version published in 2008 (A1) and 2009 (A2) EN 285:2015 is latest version Revision/amendment needed to resolve technical comments deferred from main revision Revision/amendment underway to address pressure gauge requirements
High Temperature Process Standard EN ISO 17665 Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
EN ISO 17665 EN ISO 17665-1 replaced EN 554, ISO 11134 and ISO 13683 in 2006 Specifies methods for validation and routine control for moist heat (steam) sterilization Revision underway to incorporate guidance (currently in part 2) and product families (currently in part 3) into a single standard Significant changes to EN ISO 17665 are likely to occur
Low Temperature Equipment Standards EN 1422 Sterilizers for medical purposes Ethylene oxide sterilizers - Requirements and test methods EN 14180 Sterilizers for medical purposes Low temperature steam and formaldehyde sterilizers Requirements and testing pren 17180 Sterilizers for medical purposes Low temperature vaporized hydrogen peroxide sterilizers Requirements and testing
EN 1422 EO Sterilizers EN 1422:2014 is latest version; superseded EN 1422:1997+A1:2009 Harmonised EU standard (harmonised against EU MDD 93/42/EEC) Major revision in 2014: Scope changes Explicit exclusion of sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber Removal of types A and B of EO sterilizers A - user programmable (industrial) B - typically smaller and have fixed cycles (health care) Alignment with structure of LTSF standard EN 14180 Annex D deleted (sound power test)
EN 14180 Formaldehyde Sterilizers EN 14180:2014 is latest version; superseded EN 14180:2003+A2:2009 Harmonised EU standard (harmonised against EU MDD 93/42/EEC) Major revision in 2014: The terms risk assessment, risk analysis and software validation added Biological testing aligned with method from ISO 25424 Machinery safety requirements, mainly as a consequence of compliance with the machinery directive added Requirements and testing for sound power and vibration updated
Vaporized hydrogen peroxide sterilizers Work item to develop a sterilizer standard for vaporized hydrogen peroxide sterilizers; approved in September 2015 Work began at a meeting in Brussels in February 2016 Uses vaporized hydrogen peroxide [VH2O2] as the sterilant Standard defines the design & performance of the sterilizer, rather than the process Work likely to take at least another year (mid-2019 publication)
Low Temperature Process Standards EN ISO 25424 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices EN ISO 11135 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices EN ISO 14937 Requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
EN ISO 25424 Formaldehyde Process EN ISO 25424:2011 is latest version; superseded EN 15424:2007 Harmonised EU standard Harmonised against EU MDD 93/42/EEC on Medical Devices Harmonised against 90/385/EEC on Active Implantable Medical Devices Harmonised against 98/79/EC on in vitro diagnostic medical devices
EN ISO 11135 EO Process EN ISO 11135:2014 is latest version; superseded ISO 11135-1:2007 and ISO/TS 11135-2:2008 Harmonised EU standard Harmonised against EU MDD 93/42/EEC on Medical Devices Harmonised against 90/385/EEC on Active Implantable Medical Devices Updated in 2014: It replaces ISO 11135-1:2007 and ISO/TS 11135-2:2008 Part 1 was requirements and part 2 was guidance on the application of part 1 Both technically revised and condensed into a single standard Guidance placed in annex D
EN ISO 14937 Generic Process EN ISO 14937:2009 is latest version Currently used for novel sterilization processes, e.g. hydrogen peroxide sterilization processes Harmonised EU standard Harmonised against EU MDD 93/42/EEC on Medical Devices Harmonised against 90/385/EEC on Active Implantable Medical Devices
EN ISO 17664 Information to be provided EN ISO 17664-1 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices First published in 2004, then significantly revised and published in 2017 2004 edition was for devices intended to be sterilized for their subsequent use 2017 edition is for devices intended to be disinfected and/or sterilized for their subsequent use e.g. endoscopes Specifies information to be provided by the medical device manufacturer on the processing of medical devices Includes medical devices that are intended for reuse and require processing by way of cleaning, disinfection and/or sterilization Single use devices supplied non-sterile but intended to be used in a clean, disinfected and/or sterile state
Scope of EN ISO 17664-1 Processing instructions are NOT defined (although format is ) Gives requirements to assist manufacturers in providing: initial treatment at the point of use; preparation before cleaning cleaning disinfection drying inspection and maintenance packaging sterilization storage Transport Non-critical medical devices not intended for direct patient contact are not included
EN ISO 17664-1 - Requirements Requires MD manufacturers to: validate the decontamination processes identified in the instructions for use perform risk analysis in accordance with ISO 14971 to determine the content and detail of the information provided state limitations or service life of the device with processing provide cleaning, disinfection and/or sterilization information method specified shall be relevant to the market available in electronic or printed form Provides an example pro-forma template for standardisation of IFUs
EN ISO 17664-1 Example Format
ISO 22421 Common Aspects of Sterilizers ISO has just started developing a new standard on common aspects of sterilizers; work is likely to take 3 years Its application would potentially include all types of sterilizers for health care applications It would enable common requirements across a range of equipment Scope consists of: Material, design and construction Chamber requirements Doors and interlocks Noise, heat, vapour, vibration and EMC emissions Quality & risk management Safety requirements Service and local environment Information to be provided by the manufacturer Test Equipment etc Information being considered from EN, US, Japanese and Australian sterilizer standards, as well as IEC 61010-1 and IEC 61010-2-040