An overview of sterilizer equipment standards current and planned. Richard Bancroft Science & Technical Director STERIS

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1 An overview of sterilizer equipment standards current and planned Richard Bancroft Science & Technical Director STERIS #deconevent2018

2 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

3 Equipment & Process Standards Equipment standard STANDARDS FOR DECONTAMINATION Supporting standards Process standard

4 High Temperature Sterilization Standards Equipment standard EN Equipment standard EN 285 STEAM Process standard EN ISO 17665

5 Low Temperature Sterilization Equipment standard EN 1422 Standards Equipment standard EN Equipment standard EN EO VHP FORM Process standard EN ISO Process standard EN ISO Or ISO Process standard EN ISO 25454

6 High Temperature Equipment Standards EN EN Sterilization. Steam sterilizers. Small Sterilizers EN 285 EN 285 Sterilization. Steam sterilizers. Large Sterilizers

7 EN Small Steam sterilizers EN 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

8 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

9 High Temperature Process Standard EN ISO Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

10 EN ISO EN ISO replaced EN 554, ISO and ISO 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 are likely to occur

Low Temperature Equipment Standards EN 1422 Sterilizers for

test methods EN 14180 Sterilizers for medical purposes Low

and testing pren 17180 Sterilizers for medical purposes Low

11 Low Temperature Equipment Standards EN 1422 Sterilizers for medical purposes Ethylene oxide sterilizers - Requirements and test methods EN Sterilizers for medical purposes Low temperature steam and formaldehyde sterilizers Requirements and testing pren Sterilizers for medical purposes Low temperature vaporized hydrogen peroxide sterilizers Requirements and testing

12 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 Annex D deleted (sound power test)

13 EN 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 Machinery safety requirements, mainly as a consequence of compliance with the machinery directive added Requirements and testing for sound power and vibration updated

14 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

Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices EN ISO 14937

15 Low Temperature Process Standards EN ISO 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 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices EN ISO Requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

16 EN ISO 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

17 EN ISO EO Process EN ISO 11135:2014 is latest version; superseded ISO :2007 and ISO/TS :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 :2007 and ISO/TS :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

18 EN ISO 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

19 EN ISO Information to be provided EN ISO 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 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

20 Scope of EN ISO 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

21 EN ISO Requirements Requires MD manufacturers to: validate the decontamination processes identified in the instructions for use perform risk analysis in accordance with ISO 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

22 EN ISO Example Format

23 ISO 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 and IEC

Does your equipment meet your needs and the operational capacity stated by the manufacturer?

Does your equipment meet your needs and the operational capacity stated by the manufacturer? Richard Bancroft, B.Sc (Hons) Registered Authorising Engineer (Decontamination), UK Convenor, ISO/TC 198 WG