Medical Device White Paper Series Sterilization - Regulatory .
Medical Device White Paper SeriesSterilization– Regulatoryrequirements andsupporting standardsAuthor - Eamonn Hoxey, technical author,trainer and consultant
Sterilization – Regulatory requirements and supporting standardsDisclaimer – This white paper is issued for information only. It does not constitute an official or agreedposition of BSI Standards Ltd. The views expressed are entirely those of the authors. All rights reserved.Copyright subsists in all BSI publications including, but not limited to, this white paper. Except as permittedunder the Copyright, Designs and Patents Act 1988, no extract may be reproduced, stored in a retrievalsystem or transmitted in any form or by any means – electronic, photocopying, recording or otherwise –without prior written permission from BSI. While every care has been taken in developing and compiling thispublication, BSI accepts no liability for any loss or damage caused, arising directly or indirectly in connectionwith reliance on its contents except to the extent that such liability may not be excluded in law.OverviewSterile devices are free of viable microorganisms. Regulatory requirements for medical devices includeparticular requirements for devices supplied or intended to be used in a sterile state. These regulatoryrequirements relate both to general safety and performance requirements for the products and requirementsfor independent, third-party conformity assessment of the processes or instructions for achieving sterility.These regulatory requirements have been supported by a portfolio of standards on:designating products as sterile;validating and routinely controlling the sterilization process; andmaintaining sterility over time with appropriate sterile barrier systems.This paper provides an overview of these regulatory requirements and the standards that support them.2
bsigroup.comIntroductionThe European Medical Devices Regulation 2017/745 (MDR) includes general safety and performancerequirements (GSPRs) in Annex I related to infection and microbial contamination. These GPSRs includerequirements related to sterility. The In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR)includes parallel requirements to the MDR. This paper focuses on the requirements of the MDR, but the IVDRrequirements can be considered by analogy with the guidance contained here.The regulations have specific roles for harmonized standards in demonstrating conformity. Article 8 in eachregulation indicates that harmonized standards are those referenced in the Official Journal of the EuropeanUnion. Devices in conformity with relevant harmonized standards are presumed to be in conformity with therequirements of the regulation covered by those standards. Additionally, the presumption of conformity alsoapplies to system or process requirements, including those requirements relating to risk management.In order for a standard to be harmonized under the regulations, a standardization request has to be agreedbetween the European Commission and the European Standards organizations – CEN and CENELEC. A draftof this standardization request was published by the European Commission. The European standards fordesignating medical devices as sterile, validating and routinely controlling particular sterilization processesand aseptic processing are on the list of standards to be harmonized in this draft standardization request.The deadline for adoption of most of the listed standards is 27 May 2024. This deadline applies to thestandards for designating devices as sterile, validation and routine control of sterilization processes andaseptic processing.Harmonized European standards include European Annex Zs that show the relationship between therequirements of the standard and the regulatory requirements in the European Directives or Regulations thatare applicable to the scope of that standard. Work is in progress to include Annex Zs into new editions oramendments to the applicable sterilization and aseptic processing standards.In addition, there are numerous references in the MDR to the manufacturer taking into account the generallyacknowledged state of the art. The intention of the standards for sterilization is that these are regularlyreviewed and updated as necessary in order to reflect this state of the art.BSI has published over 70 documents on sterilization and associated equipment and processes. Of these,46 are adoptions of ISO standards, most of which are common European and International standards. Theother British Standards documents are 17 adoptions of European standards that do not have internationalequivalents and nine standalone British Standards. The standalone British Standards have been in place for along time and remain either because there is no European or International standard on the topic or becausethere is a cross-reference to the document from another current standard. Work has been started recently toupdate:BS 3970, focusing on a specification for sterilizers using moist heat for fluids in sealed containers;BS 2646, giving requirements and performance tests for laboratory sterilizers; andBS 6256, focusing on a method for determination of methylene blue particulate penetration ofpackaging for terminally-sterilized medical devices.3
Sterilization – Regulatory requirements and supporting standardsRequirements of the EU Medical Devices RegulationThe scope of the MDR is wider than that of the Medical Devices Directive that it replaces. A change in thedefinition of a medical device now includes products specifically intended for the cleaning, disinfection orsterilization of devices. These were previously covered as accessories.Table 1 presents the GSPRs related to infection and microbial contamination and compares these with theessential requirements of the Medical Device Directive (93/42/EEC).Table 1 – Comparison of the requirements in relation to Infection and microbial contamination in the MedicalDevices Regulation and the Medical Devices DirectiveMedical Devices Regulation EU2017/7451Annex I General safety andperformance requirements (GSPRs)11.1. Devices and their manufacturingprocesses shall be designed in sucha way as to eliminate or to reduce asfar as possible the risk of infectionto patients, users and, whereapplicable, other persons.The design shall:(a) reduce as far as possibleand appropriate the risks fromunintended cuts and pricks, such asneedle stick injuries;Medical Devices Directive93/42/EEC2 Annex I EssentialRequirements (ERs)8.1. The devices and manufacturingprocesses must be designed in sucha way as to eliminate or reduce asfar as possible the risk of infectionto the patient, user and third parties.The design must allow easy handlingand, where necessary, minimizecontamination of the device by thepatient or vice versa during use.CommentsAddition of specific reference toneedle-stick injuries. Added detailon ‘minimizing contamination of thepatient by the device and vice versa’.(b) allow easy and safe handling;(c) reduce as far as possible anymicrobial leakage from the deviceand/or microbial exposure duringuse; and(d) prevent microbial contaminationof the device or its content such asspecimens or fluids.11.2. Where necessary, devices shallbe designed to facilitate their safecleaning, disinfection, and/or resterilisation.New emphasis on cleaning,disinfection and sterilization ofreusable devices.Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices,amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealingCouncil Directives 90/385/EEC and 93/42/EEC12COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices4
bsigroup.com8.2. Tissues of animal origin mustoriginate from animals that havebeen subjected to veterinarycontrols and surveillance adapted tothe intended use of the tissues.Notified bodies shall retaininformation on the geographicalorigin of the animals.Processing, preservation, testingand handling of tissues, cells andsubstances of animal origin mustbe carried out so as to provideoptimal security. In particular,safety with regard to viruses andother transmissible agents mustbe addressed by implementation ofvalidated methods of elimination orviral inactivation in the course of themanufacturing process.11.3. Devices labelled as havinga specific microbial state shallbe designed, manufactured andpackaged to ensure that they remainin that state when placed on themarket and remain so under thetransport and storage conditionsspecified by the manufacturer.11.4. Devices delivered in asterile state shall be designed,manufactured and packaged inaccordance with appropriateprocedures, to ensure that they aresterile when placed on the marketand that, unless the packagingwhich is intended to maintain theirsterile condition is damaged, theyremain sterile, under the transportand storage conditions specifiedby the manufacturer, until thatpackaging is opened at the pointof use. It shall be ensured that theintegrity of that packaging is clearlyevident to the final user.MDD requirement related totransmissible spongiformencephalopathies (TSEs) nowcovered in GSPR 13 - Devicesincorporating materials of biologicalorigin and Directive 2003/32/EC3 .New requirement. As 11.4 belowrelates to sterile devices, thisrequirement appears to relate tospecific microbial states other thansterility, such as devices that aresupplied with a specified level ofcleanliness, as disinfected, or withan absence of particular types ofmicroorganisms.8.3. Devices delivered in asterile state must be designed,manufactured and packed in a nonreusable pack and/or according toappropriate procedures to ensurethat they are sterile when placed onthe market and remain sterile, underthe storage and transport conditionslaid down, until the protectivepackaging is damaged or opened.Added emphasis on the sterilebarrier system.COMMISSION DIRECTIVE 2003/32/EC of 23 April 2003 introducing detailed specifications as regards therequirements laid down in Council Directive 93/ 42/EEC with respect to medical devices manufactured utilisingtissues of animal origin35
Sterilization – Regulatory requirements and supporting standards11.5. Devices labelled as sterileshall be processed, manufactured,packaged and, sterilized by means ofappropriate, validated methods.8.4. Devices delivered in a sterilestate must have been manufacturedand sterilized by an appropriate,validated method.Added emphasis on the sterilebarrier system.11.6. Devices intended to besterilized shall be manufacturedand packaged in appropriate andcontrolled conditions and facilities.8.5. Devices intended to besterilized must be manufacturedin appropriately controlled (e. g.environmental) conditions.Added emphasis on the packagingprocess for the sterile barriersystem.11.7. Packaging systems for nonsterile devices shall maintain theintegrity and cleanliness of theproduct and, where the devices areto be sterilized prior to use, minimizethe risk of microbial contamination;the packaging system shall besuitable taking account of themethod of sterilization indicated bythe manufacturer.8.6. Packaging systems for nonsterile devices must keep theproduct without deterioration at thelevel of cleanliness stipulated and,if the devices are to be sterilizedprior to use, minimize the riskof microbial contamination; thepackaging system must be suitabletaking account of the methodof sterilization indicated by themanufacturer.Essentially no changes.11.8. The labelling of the device shalldistinguish between identical orsimilar devices placed on the marketin both a sterile and a non-sterilecondition additional to the symbolused to indicate that devices aresterile.8.7. The packaging and/or label ofthe device must distinguish betweenidentical or similar products soldin both sterile and non-sterilecondition.Additional detail that thedifferentiation between sterileand non-sterile versions of similardevices is in the labelling and ismore that the presence or absenceof the sterile symbol.The GSPRs of the MDR related to infection and microbial contamination show:increased detail in the wording;additional focus on reprocessing of devices;a new category of devices having a ‘special microbial state’; andincreased focus on the sterile barrier and its identification.The requirements for conformity assessment require the intervention of a notified body for sterile medicaldevices of all classes. In addition, the MDR adds a conformity assessment requirement for a notified body toreview the instructions for reprocessing of class I reusable surgical instruments.6
bsigroup.comDesignating of medical devices as sterileThe MDR presents requirements for sterile devices but does not provide a definition of the term ‘sterile’.Sterile devices are free of viable microorganisms. The EN 556 series of standards defines requirements fordesignating device as sterile. Parts 1 and 2 of EN 556 provide requirements for terminally sterilized devicesand aseptically produced devices respectively.The standards related to designating devices as sterile and their status is shown in Table 2.Table 2 Standards related to designating medical devices as sterileStandard referenceStandard titleDate ofpublicationEN 556-1Sterilization of medical devices Requirements for medical devices to bedesignated ‘STERILE’ - Part 1: Requirementsfor terminally sterilized medical devices2001/AC:2006EN 556-2Sterilization of medical devices.Requirements for medical devices to bedesignated «STERILE». Requirements foraseptically processed medical devices2015ISO TS 19930Guidance on aspects of a risk-basedapproach to assuring sterility of terminallysterilized, single-use health care products2017CommentsAmendment underwayto add Annexes ZD andZE for the MDR andIVDR.Guidance documentand not intendedto provide anypresumption ofconformity withEuropean regulatoryrequirements.EN 556‑1 is the European standard specifying requirements for designating a terminally-sterilized device assterile. It has also been adopted in a number of countries outside Europe, for example Australia and China.EN 556‑1 specifies that a probability of a viable microorganism on a device of 10 6 or less (e.g. 10 7, et seq.)has to be achieved in order to designate a terminally sterilized medical device as sterile. The probability ofsurvival of a single microorganism is also known as the sterility assurance level (SAL).There can be, however, devices that are unable to withstand a terminal sterilization process achieving thisprobability. This might be because some or all of the materials that constitute the device are sensitive totraditional sterilization processes, for example cellular or biologically based components. EN 556‑1 includesan explanatory note that indicates that permission for acceptance of a probability greater than 10 6 (e.g.10 5) can be sought through appropriate regulatory bodies. Such permission requires consideration of theindividual situation, including the risk assessment undertaken by the manufacturer of the device. However,EN 556-1 gives no guidance on criteria that might be considered in seeking such approval and there is noalignment on how such devices should be labelled.7
Sterilization – Regulatory requirements and supporting standardsISO/TS 19930:2017 (see Table 2) provides:background information on assurance of sterility and sterility assurance level,guidance on strategies that can allow the achievement of a maximal SAL of 10 6, and,general guidance on the considerations to be taken into account in selecting a SAL for a healthcare product that is unable to withstand terminal sterilization to meet the general requirement toachieve maximally a SAL of 10 6.ISO/TS 19930 has not yet been adopted as a European Standard. It is a guidance document and not intendedto provide any presumption of conformity with European regulatory requirements. This topic is contentiousfor some regulatory agencies, conformity assessment bodies, manufacturers and national standards bodies.This TS does not relax the regulatory and quality requirements to claim that a product is sterile. Its purposeis to bridge a gap in existing standards and regulations. ISO TS 19930 provides guidance on technicalaspects when considering an alternative SAL to 10 6 for identified high clinical need, terminally sterilizeddevices unable to withstand the processing conditions necessary to achieve maximally a SAL of 10 6.When terminal sterilization is not possible, aseptic processing provides an alternative means of achieving asterile device. Aseptic processing is based on preventing contamination of sterile items. Aseptic processingis not based on inactivation of microorganisms and so the concept of extrapolation of a probability ofsurvival of a microorganism does not apply. EN 556-2 provides requirements for designating an asepticallyprocessed medical device as sterile. The EN ISO 13408 series of standards (see section on Aseptic Processingof medical devices and Table 4) provide means to support conformance with EN 556-2.8
bsigroup.comValidation and routine control of sterilization processesThere is a portfolio of European Standards for development, validation and routine control of sterilizationprocesses. These standards are European adoptions of International Standards. The standards and theirstatus are listed in Table 3. These standards for validation and routine control of sterilization are listed in thedraft Standardization Request of priority standards to be harmonized for the MDR.Table 3 Standards for development, validation and routine control of a sterilization processStandard referenceStandard titleDate ofpublicationCommentsEN ISO 14937Sterilization of health care products General requirements for characterizationof a sterilizing agent and the development,validation and routine control of asterilization process2009Provides structure usedin all the standards forvalidation and routinecontrol of sterilizationprocesses. Givesrequirements for anyprocess which doesnot have a specificstandard for validationand routine control.EN ISO 11135Sterilization of health-care products Ethylene oxide - Requirements for thedevelopment, validation and routine controlof a sterilization process for medical devices2014 AMD1:20192019 amendmentchanges the Annex onsingle batch validationand adds Annexes ZDand ZE for the MDR andIVDR.ISO TS 21387Sterilization of health care products– Ethylene oxide - Guidance on therequirements for processes usingparametric releaseEN ISO 11137-1:Sterilization of health care products- Requirements for the development,validation and routine control of asterilization process for medical devices Radiation - Part 1: RequirementsTechnical Specificationdue for publication in20202006/AMD12013, AMD220192019 amendmentaddresses useof measurementuncertainty in productrelease and addsAnnexes ZD and ZE forthe MDR and IVDR.9
Sterilization – Regulatory requirements and supporting standardsEN ISO 11137-2Sterilization of health care products- Requirements for the development,validation and routine control of asterilization process for medical devices- Radiation - Part 2: Establishing thesterilization doses2013Provides the methodsfor establishing asterilization doesfor sterilization byirradiation.BS EN ISO 11137-3Sterilization of health care products.Radiation. Guidance on dosimetric aspectsof development, validation and routinecontrol2017Provides guidanceon the application ofdose measurements(dosimetry) duringall stages of thesterilization process.ISO CD TS 11137-4Sterilization of health care products Radiation - Part 4: Guidance on processcontrolISO TS 13004Sterilization of health care products –Radiation – Substantiation of a selectedsterilization dose: Method VDmaxSD2013Extends the methodfor substantiation ofa sterilization doss forradiation sterilizationfrom the use of 15kGyand 25kGy given in ENISO 11137-2.ISO 17665-1Sterilization of health care products –Moist heat – Part 1: Requirements for thedevelopment, validation and routine controlof a sterilization process for medical devices2006Revision started tocombine parts 1, 2and 3.CEN/ISO TS 17665-2Sterilization of health care products - Moistheat - Part 2: Guidance on the application ofISO 17665-12009ISO TS 17665-3Sterilization of health care products - Steamsterilization - Part 3: Product families2013EN ISO 20857Sterilization of health care products – Dryheat – Requirements for the development,validation and routine control of anindustrial sterilization process for medicaldevices2013Technical specificationin development.10
bsigroup.comEN ISO 25424Sterilization of medical devices – Lowtemperature steam and formaldehyde –Requirements for development, validationand routine control of a sterilization processfor medical devices2019Includes Annexes ZDand ZE for the MDR andIVDR.EN ISO 14160Sterilization of health care products - Liquidchemical sterilizing agents for single-usemedical devices utilizing animal tissuesand their derivatives - Requirements forcharacterization, development, validationand routine control of a sterilization processfor medical devices2011New edition of thestandard awaitingpublication. Newedition includesAnnexes ZD and ZE forthe MDR and IVDR.ISO NP 22441Sterilization of health care products - Lowtemperature vaporized hydrogen peroxide- Requirements for the development,validation and routine control of asterilization process for medical devicesStandard indevelopmentThe standards are intended to ensure that the sterilization process is reliable and reproducible. Reliability andreproducibility provide confidence that predictions can be made that there is an acceptable, low probabilityof there being a viable microorganism present on device after sterilization. These standards provide a meansto demonstrate conformity with the requirements for sterility for terminally-sterilized medical devicesspecified in EN 556-1.All the standards for validation and routine control have a common format and use a common set ofdefinitions. The common structure includes:Sterilizing agent characterization – defines the sterilizing agentProcess and equipment characterization – defines the entire sterilization process and theequipment necessary to deliver the sterilization process safely and reproduciblyProduct definition – defines the product to be sterilized, including the microbiological quality ofthe product prior to sterilization and the manner in which product is packaged and presented forsterilizationProcess definition – details a specification for the sterilization process to be applied to the definedproductValidation – demonstrates that the sterilization process established in the process definition canbe delivered effectively and reproducibly to the sterilization load. Validation consists of installationqualification (IQ), operational qualification (OQ) and performance qualification (PQ) IQ is undertaken to demonstrate that the sterilization equipment and any ancillary items havebeen supplied and installed in accordance with their specification11
Sterilization – Regulatory requirements and supporting standards OQ is carried out either with unloaded equipment or using appropriate test materials todemonstrate the capability of the equipment to deliver the sterilization process that has beendefined PQ is the stage of validation that uses product to demonstrate that the equipment consistentlyoperates in accordance with predetermined criteria and the process yields product that issterile and meets the specified requirementsRoutine monitoring and control – demonstrates that the validated and specified sterilizationprocess has been delivered to the productProduct release from sterilization – specifies the procedure for product release from sterilizationMaintaining process effectiveness – addresses ensuring the consistent condition of productpresented for sterilization, maintenance and calibration of equipment, assessment of changes toproduct, process or sterilizing equipment and periodic requalificationAn amendment to EN ISO 11135 for ethylene oxide sterilization was published in late 2019. The amendmentchanges one of the Annexes in the standard – Annex E: Single batch release. This annex covers requirementsfor releasing product from a sterilization process that is not in routine production – for example, duringdesign and development, including product for clinical investigation. This approach can be applicable if anew product cannot be assigned to an existing family of products for the purposes of sterilization validation.The changes to Annex E provide more detail, in particular on the need to select a suitable sample ofproducts for:evaluating bioburden;determining a suitable process challenge device (PCD) with biological indicators (BIs) to beincorporated within the sterilization load;performing tests of sterility;determining ethylene oxide residuals;performing stability tests, functionality tests, testing for biological safety and any other necessaryevaluations such as tests for the presence of bacterial endotoxins.12
bsigroup.comThe approach described in Annex E is to expose the sterilization load, incorporating PCDs with BIs, andtemperature and humidity sensors, to an ethylene oxide process with the exposure time set to half thesterilization cycle time (called a half cycle). The BIs from the PCDs are tested and product items from the halfcycle undergo a test of sterility. After aeration and equilibration to ambient conditions, the load from the halfcycle undergoes a full sterilization cycle with temperature and humidity sensors and new PCDs incorporatingBIs included. Product is tested for functionality and ethylene oxide residuals after exposure to both the halfcycle and full sterilization cycle. Criteria for release of product include, but are not limited to:conformance to the process specification for the half cycle and full sterilization cycle;no growth from BIs from the half cycle and full sterilization cycle;no positive tests of sterility from the half cycle; andethylene oxide residual levels complying with EN ISO 10993-7, Biological evaluation of medicaldevices - Ethylene oxide sterilization residuals after exposure to both the half cycle and fullsterilization cycle.13
Sterilization – Regulatory requirements and supporting standardsAseptic processing of medical devicesAs indicated above, aseptic processing provides an alternative means of achieving a sterile device whenterminal sterilization is not possible and the EN ISO 13408 series of standards provide means to supportconformance with EN 556-2. The standards in the EN 13408 series and their status are indicated in Table 4.Table 4 Standards for aseptic processingStandard referenceStandard titleDate ofpublicationEN ISO 13408-1Aseptic processing of health care products –Part 1: General requirements2011/AMD12013EN ISO 13408-2Aseptic processing of health care products –Part 2: Filtration2018EN ISO 13408-3Aseptic processing of health care products –Part 3: Lyophilization2011EN ISO 13408-4Aseptic processing of health care products –Part 4: Clean-in-place technologies2011EN ISO 13408-5Aseptic processing of health care products –Part 5: Sterilization-in-place2011CommentsRevision just startingUnder revisionEN/ISO 13408-6Aseptic processing of health care products –Part 6: Isolator systems2011EN ISO 13408-7Aseptic processing of health care products –Part 7: Aseptic qualification of solid medicaldevices and combination medical devices2015ISO 18362Manufacture of cell-based health careproducts – Control of microbial risks duringprocessing2016EN ISO 13408 presents general requirements of aseptic processing in Part 1. Subsequent parts of the seriesprovide additional details on specific aspects of aseptic processing. Aseptic processing of solid medicaldevices can present particular issues and EN ISO 13408-7 is specifically focused on solid devices.14
bsigroup.comISO 18362 addresses the processing of cell-based products. A cell-based health care product comprisescells or cell-derived biological entities as an essential ingredient. Cell-based or cell derived starting materialcan be viable or non-viable and of human, animal, microbial or plant origin. Such products are classified asmedicines, medical devices, biologics or combination products depending on the international, national and/or regional regulations that govern their supply. Cell-based products can have limited ability to withstandsterilization and purification methods. ISO 18363 describes the minimum elements necessary for a risk-basedapproach to the processing to reduce the potential for an increase in intrinsic contamination of product andto avoid extrinsic contamination of product.Microbiological methodsThere are several microbiological methods that are used in developing, validating and routinely controllingsterilization processes. These methods relate to estimation of the population of microorganisms on aproduct prior to sterilization, determining the bioburden and determining the presence or absence of viablemicroorganism through performing a test of sterility. The principles for conducting these microbiologicalmethods are described in the EN ISO 11737 series of standards and are outlined in Table 5.Table 5 Standards for microbiological methods used in development, validation and routine control ofsterilizationStandard referenceEN ISO 11737-1Standard titleSterilization of medical devices.Microbiological methods. Determinationof the population of microorganisms onproductsDate ofpublication2018CommentsAmendment in process15
Sterilization – Regulatory requirements and supporting standardsEN ISO 11737-2Sterilization of medical devices.Microbiological methods. Tests of sterilityperformed in the validation of a sterilizationprocessISO 11737-3Sterilization of medical devices –Microbiological methods – Part 3: Bacterialendotoxin testingIn preparationISO TS 22456Sterilization of healthcare products –
The European Medical Devices Regulation 2017/745 (MDR) includes general safety and performance requirements (GSPRs) in Annex I related to infection and microbial contamination. These GPSRs include requirements related to sterility. The In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) includes parallel requirements to the MDR.
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