Regulation and standards

The texts governing medical devices reprocessing and education activities may be grouped in 3 categories : 

  • Regulation (or legislation): Published by govermental bodies, they are of compulsory application. They can be national like in the USA1 or supra-national like in the European Union2. Example of key regulatory aspects pertaining to medical device reproccessing are the obligations for Medical Device Manufacturers to provide reprocessing instructions, for Healthcare facilities to report  incidents related to Medical Device including those related to reprocessing. Regulation may also structure sterilization activities in a given country (for example, authorization to open a sterilization department, qualification required to Manage a CSSD, audit rules etc….),  The present guidelines will not comment regulation.
  • Standards (also referred to as norms): They set common expectations on products, services or processes to facilitate trade and enhance end user confidence and safety. Standards can be specific (for example steam sterilization processes or equipments) or transversal (for example, Quality Management). Standards are defined by consensus. Standards can be international (for example ISO), Regional (for example CEN for the European Union or national (DIN, BS etc..). National standards (i.e. applicable in only one country) will not be commented in this paragraph. ISO standards exist for sterilization but not for disinfection. Countries select the applicable standard for the various disinfection claim. (for example CEN and/or AOAC or ASTM)


  • Standards are generally of voluntary application. Some can be made mandatory by local regulation. In practice, once a standard is adopted, it is convenient and safe for manufacturers, users and health care authorities to seek or verify compliance. When compliance is stipulated in a contract it is binding on the parties

  • Guidelines (also referred to as recommended practices or best practices) are published by scientific societies, governmental bodies or standard organizations. Standards ease the interpretation of regulation and standards by healthcare facilities and serve as a framework for education programs and audits. 


      At national level, guidelines are often co-written by 2 or more entities (for example Scientific societies and governmental bodies) or written by societies and endorsed by governments

In case of overlaps the applicable regulation always supersedes standards and guidelines.  

International sterilization and washer-disinfector Standards

ISO sterilization and washer-disinfector standards are under the responsibility of Technical Committee 198 (TC 198). EN sterilization and washer-disinfection standards are under CEN TC 102, and CEN TC 204.

Standards are prepared by experts nominated by their national delegations.

Proposal for a new standard may be submitted via a national delegation or by ISO or CEN technical committees. 

Once the scope of new work item proposal is approved by a majority of ISO or EN country members, the project is assigned by the Technical Committee to a working group. 

The first draft is often prepared by the initiators of the project. It is circulated for comments by national committees. Comments are then reviewed one by one by the working group experts. 

Several rounds of drafts, votes and comments review are usually needed until a consensual text is obtained and submitted for final approval. Along the road, collaborative tests may be needed to align on performance thresholds. Details can be obtained on ISO or CEN websites.

Once published, Standards are periodically submitted for revision, amendment, confirmation or withdrawal.


        In the case of the European community, the compliance to an harmonized standard (i.e. a standard endorsed by the CEE) indicates that the essential requirement of the medical device regulation are met. Standards are also used as a reference by notified body for CE marking.


       Standards are subject to copyright and fees. Revenues generated by the sales of standards are used to finance the standardization effort and organizations.


There are many standards but not all products or processes are covered by standards. For example there are ISO and EN standards for automated cleaning and disinfection processes but none for manual processes. 

The figure below illustrates ISO and CE framework for sterilization activities. It is provided for illustration purpose only. This diagram is subject to constant change and only valid for the indicated period. Official list and status can be found on ISO and CEN websites


       Radiation sterilization standards which are not commonly used in routine in healthcare facilities are not represented. 

Some new standards in development (but not yet published) are displayed with a WIP tag (Work In Progress). 

Sterilization process standards are intended for all stakeholders involved in device reprocessing i.e. healthcare facilities, manufacturers of reprocessing equipment or consumables, as well as manufacturers of medical devices and service providers.  

For example, the sterilization process standards3,4,5,6,7,8,9,10 will be used by:

  • healthcare facilities to develop and implement procedure for validation, routine control, load release and maintaining process effectiveness over time
  • sterilizer manufacturers for the characterization of the sterilizing agent, equipment and cycles, 
  • manufacturers of reusable medical devices to validate that the devices can be efficiently and safely reprocessed 
  • manufacturers of single-use medical devices 
  • organizations performing sterilizing services to healthcare facilities or medical devices manufacturers
  • organization performing validation services for healthcare facilities or medical devices manufacturers

Packaging standards 11,12 and guidance 13  will be used by healthcare facilities for  packaging process validation.  Most of the requirements included in the standards will however be for manufacturers of single use devices and for manufacturer of sterile barrier systems (SBS) and for packaging materials.

Other standards or guidances are primarily intended for manufacturers of sterilizing equipment, consumables or medical devices. They define the requirements and test methods to be applied to justify compliance. Those standards are however also of interest for healthcare facilities. For example, sterilizers standards may be used to prepare tenders,  

Examples of non TC 198 standards to which ISO and EN sterilization standards commonly refer are:

  • ISO 1348548 and ISO 1497149 for quality management and risk management,
  • IEC 61010-2-4050 for safety (electrical, environmental etc..) of sterilizers and washer-disinfector

ISO 1099351,52,53 for the evaluation of the biological safety of the material after exposure to a sterilization or cleaning process

ISO standards for thermal and chemical washer-disinfectors 35,36,37,38,39 are also primarily intended for manufacturers. However they contain guidance for healthcare facilities to check the conformity of installed washer-disinfector throughout its working life. ISO 15883-440 and EN 1644241 are dedicated to heat sensitive flexible endoscopes (reprocessing and storage respectively). ISO 15883-542 describes test method and criteria for cleaning efficacy

 


       EN sterilization standards are often referred to as equipment standards and ISO standards as process standards. This is not an official ISO language but it well depicts the respective role of each group of standards.

Other ISO TC 198 standards and guidance displayed on the above diagram come in support of other TC 198 documents.

Examples of non TC 198 standards to which ISO and EN sterilization standards commonly refer are:

  • ISO 1348548 and ISO 1497149 for quality management and risk management,
  • IEC 61010-2-4050 for safety (electrical, environmental etc..) of sterilizers and washer-disinfector

ISO 1099351,52,53 for the evaluation of the biological safety of the material after exposure to a sterilization or cleaning process

In the above diagram key standards not belonging to ISO TC 198, EN TC 102 or TC 204 but to which ISO and EN standards refer, are also displayed

Examples of non TC 198 standards to which ISO and EN sterilization standards commonly refer are:

  • ISO 1348548 and ISO 1497149 for quality management and risk management,
  • IEC 61010-2-4050 for safety (electrical, environmental etc..) of sterilizers and washer-disinfector

ISO 1099351,52,53 for the evaluation of the biological safety of the material after exposure to a sterilization or cleaning process

The following diagram illustrates how the various sterilization, washer-disinfector, BI, CI, processing information and packaging standard may be used by healthcare facilities, manufacturers of processing equipments and consumables as well as medical device manufacturers 


Normative language can sometimes be difficult to translate into practical considerations for healthcare facilities. Some possible explanations are listed below (not exhaustive): 

  • Standards contributes to the improvement of business practices by stimulating competition, innovation and avoid products that could put operator or patient at risk. Normative language hence is carefully chosen to avoid commercial bias, avoid design restrictive requirement which could hinder innovation, ensure complementarity with safety standards. 
  • Sterilization standards apply to reprocessing of medical device by both healthcare facilities and manufacturers of medical devices. Normative Requirements must hence be compatible with 2 domains with significant differencies. 

       An example of a difference between healthcare facilities and device manufacturing industry are loads configurations: Typical single use medical device manufacturer loads are homogenous (i.e. same single use item with initial contamination levels under control. Typical healthcare facility load are heterogenous (i.e. different devices with variable levels of contamination even after thorough cleaning) 

  • Standard must be compatible with local guidelines or regulation. For example, responsibility assignments (who does what) are considered as guidelines or regulation matters are not addressed by standards.

       Some standards provide informative (non normative) guidance that will describe responsability assignements for various scenario such as healthcare facility. 

  • Among the standards of highest level of interest to user there are the sterilization process standards. The table content of those standard is aligned on ISO 14937.

The sterilization process standards contain a foreword, an introduction,12 normative paragraphs and a variable number of normative or informative annexes.

  • Foreword:  reminding key ISO principles 
  • Introduction: provides general information on the purpose of the standard, reminds some key principles of sterility assurance and quality management common to all sterilization process standards. It also explain which part of the text are normative (i.e. those containing normative requirements) and those which are of informative nature (i.e. supporting the normative paragraph). It is also reminded that process standards apply to both healthcare facility and medical device manufacturing domains.

The first three normative paragraphs equally apply to all categories of potential user of the standards.

  1. Scope defines what is covered or not covered by the standards (inclusions and exclusions) and who are the potential users of the standard. An exclusion common to all process standards is prion inactivation. Although some sterilization process such as some hydrogen peroxide cycles are effective on prion, methods used to evaluate activity are not standardized. 
  2. Normative reference lists the published standards to which the process standard refers
  3. Terms and definition provides the definition of standardized terms used by the process standards. Most definitions come from ISO 11139 (Vocabulary of terms used in sterilization and related equipment and process standards). Notes specific to a given sterilization technology may be added after the ISO 11139 definition.
  4. Quality management system reminds high level quality management guidance for all organizations concerned by the standard. Manufacturers are certified according to ISO 13485 or other applicable quality management framework. In some countries, some sterilization departments are certified according to ISO 13485 or other quality management norms
  5. Sterilization agent  characterization is in hands of sterilizer manufacturer. It with the evaluation of microbial efficacy, impact on properties and biological safety of materials after exposure. Evidence comes from scientific peer reviewed literature and experiments run by the sterilizer manufacturer. The amount of experimental data to be provided by the manufacturer depends on the sterilization modality. For example, there is less to be proven for standardized steam cycles than with manufacturer specific H2O2 cycle. The healthcare facility reviews the information that must be made available by the sterilizer manufacturer.
  6. Process and equipment characterization. Each propcess standard lists process and cycle variables that must be measured to verify the process. The manufactiuer of the sterilizer may add more variables. The steriizer manufacturer defines the parameters (values range) for each variable and means by which those parameters are controlled and monitored. Healthcare facility reviews the information provided by the sterilizer manufacturer. Process variables have an impact on the microbicidal effectiveness, Cycle variables are needed to control and monitor the process but have no impact on microbial effectiveness. For example, process variables for steam sterilization are time and Temperature (T°C). Pressure is a cycle variable. Parameters are the value of the variables including tolerances. 
  7. Product definition. For this paragraph, the product is the adequately cleaned and packaged medical device or surgical set. After checking that the sterilizer and cycle is approved by the medical device manufacturer (MDM), the healthcare facility writes the cleaning and packaging procedure in accordance with the instructions for reprocessing that must be provided and validated by the MDM. 
  8. Process definition; The medical device manufacturer (MDM) must verifies that a given medical device can be sterilized and remains safe and fully functional after the number of reprocessing cycles that he has defined. Sterilizer manufacturer is commonly involved to support sterility tests with his expertise. For reprocessing of reusable medical device in healthcare facilities sterilty efficacy is according to the overkill principle (described in normative annex of the process standard). The MDM may subcontract functionality test but the evaluation is under its responsibility. If different cycles are recommended by the manufacturer IFU, evidence must be available for each cycle. If the medical device contains material for which no adequate date are available in term of biological evaluation, test must be performed. As specified in 7, product Product may be grouped by family to reduce the number of tests but justification for grouping must be provided. 
  9. Validation; The healthcare facility may contract with sterilizer manufacturer for installation qualification (IQ) and operational qualification (OQ) and, with sterilizer manufacturer or third party, for performance qualification (PQ) . The healthcare faciliy must however validate and sign all qualification reports.
  10. Routine control and monitoring. Process standard require the control, monitoring and recording of cycle parameters but do not impose the use of BI and CI. Requirement or guidance are technology or country dependent. 
  11. Product release from sterilization Practices are country and modality dependent and in accordance with 10. Parametric release may be systematic (for example for steam in Western Europe). For other modalities, BI may be used, peridodically (each week, day) or systematically.
  12. Maintaining process effectiveness the healthcare facility may contract with the sterilizer manufacturer for maintenance, operational requalification, performance requalification or qualified third party for performance requalification 
Disinfection standards

Unlike for sterilization, there are no universal ISO Standards for evaluation of disinfection chemicals. Depending on the region different methods and acceptance criteria apply. 


       For example EN standards in Europe, AOAC or ASTM in USA. Some countries may look at both EN and AOAC and ASTM, in some cases, with adaptations (for example Australia) 


Disinfectant are commonly classified in 3 categories: low level, intermediate level and high level. However the borders between each category are not universally defined. For example high level disinfection is always associated to some level of efficacy on spores but the efficacy threshold on spores is not the same. 

An example of a commonly used definition for a sporicidal formulation is: a germicide that inactivates all microbial pathogens, except large numbers of bacterial endospores (Rutala 1990, Spaulding 1970). However the applicable test method and criteria is country dependent different. For example : 

  • US FDA definition for a high-level disinfectant is:  a “sterilant” used for a shorter contact time to achieve a 6-log10 kill of an appropriate Mycobacteriumspecies. High level disinfectant must hence first qualify as a “sterilant” The FDA definition differs from the ISO one and is based upon AOAC 966.0454  . It requires a total of 720 carriers (360 penicyclinders and 360 silk sutures loops) containing > 6 log of spores of Bacillus subtilis or Clostridium sporogenes. 3 different lots of the tested chemical are used. All 720 carriers must be negative after a pre-defined exposure time. The same formulation is then tested according to the same principles (720 carriers) at the claimed (shorter) exposure time except that spores are replaced by > 6 log of Mycobacterium bovis or Mycobacterium terrae or an alternative equivalent mycobacterium species prepared according to AOAC 965.1255 . The chemistry must also demonstrate fungicidal activity (Trichophyton mentagrophytes according to AOAC 955.1756), efficacy on Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa, according to (AOAC 955.1457, 955.1558, and 964.0259) and virucidal activity. 
  • Australia TGA high-level disinfectant is not necessarily a “sterilant” according to FDA but also use qualitative tests inspired by FDA. At the labelled exposure time, there must not be more than 2 positive carriers on a total of 60 with >  6 log of spores using AOAC Sporicidal Test (AOAC 966.0454, ASTM E219760 or a modified EN 1712666 (EN suspension sporicidal norm – see below)).
  • EN has no specific criteria for high level disinfectant and sporicidal tests are quantitative (log-reduction objective) instead of qualitative (no growth on a defined quantity of carriers) like in US and Australia

Unlike for sterilization in health care facilities, where sterility test are performed only with the germs predetermined as the most resistant, disinfection claims are for specific categories of germs : bacteria, fungi and yeast, virus (envelopped and non envelopped) and mycobacteria and spores, expressed in log reduction, with log reduction objective which may differ between catgories of microorganismes and region. 


       For sterilization in healthcare facilities according to the overkill principle: > 6 log of the spore selected as the most resistant to the sterilization process and SAL of 10-6

In the European community the test method to be applied for the various type of disinfection claims are defined by EN 14885.

EN 1488561 covers human medicine, veterinary, food, industrial, domestic and institutional areas. Within the medical domain EN 14885 proposes adapted substantiating strategies for various field of application hand hygien (hygienic handrub, hygienic handwash, Surgical Handrub or-wash), surface disinfection (with or with mechanical action and airbone), textile disinfection and aqueous system and instrument disinfection.

The rest of this paragraph will focus on disinfection of instruments.

EN 14885 list test in suspension (phase 2.1) or on carrier (Phase 2.2). For medical devices, phase 2.2 carrier tests are more representative of real life and closer to AOAC and ASTM approach. 

Interference matter is added to simulates soil (in clean or dirty condition depending on the application)

Test are performed at the concentration and exposure time specified by the manufacturer. At the end of the exposure time a neutralizer is added to stop the microbiocidal activity before counting to check that the targeted log reduction is achieved.

Detergent

Unlike for disinfectant there are no international standard for the evaluation of cleaning efficacy but the efficacy of the cleaning process (i.e. combination of mechanical and chemical action) can be evaluated according to ISO 15883-5. 


        Although ISO 15883-5 was developped for the evaluation of automated process. It may be applied to manual processes with the drawback, for manual processes, that there are operator dependence.

Synthesis: standards for terminal sterilization, liquid sterilant, disinfection and detergent

The illustration below is an attempt to illustrate the objectives and related normative or regulation framework for terminal sterilization, liquid sterilant, the various categories of disinfectants, prion inactivation and detergent.

  • The disinfection claims are according to efficacy on germs of increasing resistance (from envelopped viruses and bacteria to spores). Applicable tests methods and criteria are region or country dependent. High-level disinfectants must have some level of activity on the most resistant  germs i.e. spores (In addition to being efficient on all other categories of micro-organisms). Test methods and thresholds for high-level disinfection are country/region dependent. 
  • Liquid sterilant is unique to US FDA (and country which follows FDA guidance). Sterilant means a 6 log reduction of spores. FDA reminds that liquid sterilant are not equivalent to sterilization. 
  • Exposure to a sterilant is followed by rinsing which may present a risk of recontamination and the liquide sterilized device is not protected by a sterile barrier system. Sterilant will hence only be used for critical devices when terminal sterilization cannot be performed.
  • Terminal sterilization with steam or low temperature processes  are the preferred methods for critical devices. Sterility is preserved until aseptic opening of the SBS.
  • Prion inactivation is not universally standardized but recognized in vivo and in vitro methods exist. According to these tests methods, prion inactivation can be obtained by sterilization (for example some H2O2 cycles), some powerful detergent (for example high pH alkamine), or specific combination of detergent and sterilization processes. Some sterilization method are know as fixative on prion (i.e. reinforce their adherence on surfaces – for example dry heat, EO, Formaldehyde). Attention paid to prion risk is highly country dependent.
  • There is no universal standard for evaluation of cleaning agent performances but cleaning process (i.e. mechanical action + Chemical action) can be benchmarked against ISO 15883-5. 
Guidelines

Guidelines may be specific to a given topic, for example steam sterilization or global like WFHSS guidelines. Some guidelines are access free like WFHSS. For other, fees must be paid. 

WFHSS guidelines and other worldwide or regional guidance do not supersede local guidelines when they exist. See Guidelines for example of international, local or regional guidelines

  • The specific objective of the WFHSS guidelines is to share and promote best practices and encourage alignment on best available evidence based practice.

     

It is often considered that significant differences exists between guidelines. In reality, core reprocessing directives are common and differences are in the how. 

  • For example, there is a consensus on need to avoid drying of soil on instrument but there can be different opinions on how this is best achieved. Another key difference which is often outined pertains to the use of biological indicators for load release. There again, difference may not be as big as it seems. All standards requires validation and systematic control of process parameters. In some countries however bacteriological indicators and chemical will be commonly used in routine while other will rely solely or mainly on careful revision of process parmeters (so-called parametric release). Countries which use BI often release the load before the BI can be read and use BI or CI as a double check.
WFHSS recommendations for regulation, standards and guidelines
  1. Sterilization training and practices are governed or guided by international and/or regulation, standards and guidelines. Core principles are common to all countries but interaction and role played by each category of text vary according  to country history.
  2. Regulation is country or region specific. Some device reprocessing responsibilities are defined by national or supra-national medical device regulations. Organization of sterilization activities may also be defined by governmental bodies.
  3. International  standards for sterilization and washer disinfector define common expectations that contribute to facilitate trade and enhance confidence. Applicable standardization framework may however vary according to countries. There are no ISO standards for disinfection and no universal definition of High Level Disinfection. Disinfectant activities evaluation method and acceptance criteria are defined by local regulation or guidance.
  4. Guidelines complete and ease interpretation of regulation and standards. They serve as a framework for education and trainings. WFHSS guidelines do not replace national guidelines when they exist but can be used when they are none or used to achieve progressive alignment on best practices across the world.
Standards and guidelines flowchart
Bibliographic references – Regulation, standards and guidelines
  • Title 21 CFR parts 800-1299
  • Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 on medical devices
  • ISO 17665-1: Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices – 2006
  • ISO 17665-2: Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1 (2009)
  • ISO 17665-3: Sterilization of health care products – Moist heat – Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization (2013)
  • ISO/DIS 22441: Sterilization of health carte products – Low temperature vaporized hydrogen peroxide – requirements for development, valudation and routine control of a steriization process for medical devices (Work In Progress)
  • ISO 11135: Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (2014)
  • ISO 25424: Sterilization of health care products – Low temperature steam and formaldehyde – requirements for development, valudation and routine control of a steriization process for medical devices (2018)
  • ISO 20857: Sterilization of health care products – Dry heat – requirements for development, valudation and routine control of a steriization process for medical devices (2010)
  • ISO 14937: Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (2009)
  • ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (2019) 
  • ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (2019) 
  • ISO 16775: Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2 (2014) 
  • EN 285: Sterilization – Steam sterilizers – Large sterilizers – 2016
  • EN 13060: Sterilization – Steam sterilizers – Small steam sterilizers – 2018
  • EN 1422: Sterillizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods (2014)
  • EN 14180: Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – requirements and testing (2014)
  • EN 17180: Sterilizers for medical purposes – Low temperature vaporized hydrogen peroxide sterilizers – requirements and testing (Work In Progress)
  • EN 868 2 to 10 Packaging for terminally sterilized medical devices – Part 2 to 10.
  • ISO 11138-1 Sterilization of health care products — Biological indicators — Part 1: General requirements (2017)
  • ISO 11138-2 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (2017)
  • ISO 11138-3 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for moist heat sterilization processes (2017)
  • ISO 11138-4 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes (2017)
  • ISO 11138-5 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (2017)
  • ISO/AWI 11138-6 Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processes (Work In Progress)
  • ISO 11138-7 Sterilization of health care products — Biological indicators — Part 7: guidance for the selection, use and interpretation of results (2019)
  • ISO 11140-1: Sterilization of Health care products – Chemical indicators – Part 1: General requirements (2014)
  • ISO 11140-3: Sterilization of Health care products – Chemical indicators – Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (2007)
  • ISO 11140-4: Sterilization of Health care products – Chemical indicators – Part 4: Class 2 indicators as an alternative to Bowie and  Bowie and Dick-type test for detection of steam penetration test (2007)
  • ISO 11140-5: Sterilization of Healthcare products – Chemical indicators – Part 5: Class 2 indicators for Bowie and  Bowie and Dick-type air removal test (2007)
  • ISO/DIS 11140-6: Sterilization of Healthcare products – Chemical indicators – Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers Bowie and  Bowie and Dick-type air removal test (Work In Progress)
  • ISO 17664-1: Sterilization of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1 critical and semi critical medical devices (2021)
  • ISO 17664-2: Sterilization of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2 non-critical medical devices (2021)
  • ISO/DIS 22421: Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities (2021)
  • ISO 15883-1 : Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (2006)
  • ISO 15883-2 : Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (2006)
  • ISO 15883-3 : Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (2006)
  • ISO 15883-6 : Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (2011)
  • ISO 15883-7: Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (2016)
  • ISO 15883-4 : Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (2018)
  • EN 16442: Controlled environment storage cabinet for processed thermolabile endoscope (2015)
  • ISO 15883-5: Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (2021)
  • ISO 11139: Sterilization of health care products – Vocabulary of terms used in sterilization and related equipment and process standards (2018) 
  • ISO 11737–1: Sterilization of health care products – Microbiological method – Part 1: Determination of a poluplation of microorganisms onproducts (2018)
  • ISO 11737–2: Sterilization of health care products – Microbiological method – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (2018)
  • ISO/CD 11737–3: Sterilization of health care products – Microbiological method – Part 3: bacterial endotoxin testing (Work In Progress)
  • ISO/TS 5111: Quality of water for sterilizers, sterilization and washer-disinfectors (work in progress)
  • ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes (2016)
  • ISO 14971: Medical devices – Application of risk management to medical devices (2019)
  • IEC 61010-2-40: Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-40: Particular requirements for sterilizers and washer-disinfecfors used to treat medical material (2020)
  • ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (2018)
  • ISO 10993-7 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (2019)
  • ISO 10993-17 Biological evaluation of medical devices – Part 7: Establishment of allowable limits for leachable substances (2002)
  • AOAC 966.04-2002, Sporicidal Activity of Disinfectants
  • AOAC 965.12-1967(2008), Tuberculocidal activity of disinfectants
  • AOAC 955.17-1955, Fungicidal activity of disinfectants. Using trichophyton mentagrophytes
  • AOAC 955.14-1959(2006), Testing disinfectants against salmonella
  • AOAC 955.15-1959(2009), Testing disinfectants against staphylococcus aureus.
  • AOAC 964.02-2012 Testing Disinfectants Against Pseudomoans aeruginosa
  • ASTM E2197 Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
  • EN 14885 Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics (2022)
  • EN 13727:2012+A2:2015: Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity in the medical area. Test method and requirements (phase 2, step 1)
  • EN 13624:2021: Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area – Test method and requirements (phase 2, step 1)
  • EN 14348:2005: Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants. Test methods and requirements (phase 2, step 1)
  • EN 14476 +A2 : Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity in the medical area – Test method and requirements (Phase 2/Step 1)
  • EN 17126 EN 17126: 2018: Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area – Test method and requirements (phase 2, step 1)
  • EN 14561:2006 : Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area. Test method and requirements (phase 2, step 2)
  • EN 14562:2006: Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2)
  • EN 14563:2008: Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area – Test method and requirements (phase 2, step 2)
  • EN 17111: 2018: Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of virucidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2

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“The WFHSS executive committee is pleased to put the WFHSS Guidelines at your disposal.
They have been written for all the professionals working directly or indirectly in the field of the reprocessing of Reusable Medical Devices (RMD) used in Health Care facilities.

They are the result of a consensus from a review of national practices, standards, regulations.
They are intended to provide guidance and the state of the art recommendations from an academic world society focused on science but their purpose is not to supersede local regulation, standards or guidelines.
They will be updated regularly to follow the evolution of the science and the evolution of the RMD and the technologies.

Your feedback is essential to contribute to the improvement of the Guidelines , feel free to use the form to send your comments or suggestions.

We wish you interesting reading!

On behalf of the Executive Committee

Dr Christine DENIS, President”  

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“The WFHSS executive committee is pleased to put the WFHSS Guidelines at your disposal.
They have been written for all the professionals working directly or indirectly in the field of the reprocessing of Reusable Medical Devices (RMD) used in Health Care facilities.

They are the result of a consensus from a review of national practices, standards, regulations.
They are intended to provide guidance and the state of the art recommendations from an academic world society focused on science but their purpose is not to supersede local regulation, standards or guidelines.
They will be updated regularly to follow the evolution of the science and the evolution of the RMD and the technologies.

Your feedback is essential to contribute to the improvement of the Guidelines , feel free to use the form to send your comments or suggestions.

We wish you interesting reading!

On behalf of the Executive Committee

Dr Christine DENIS, President” 

Reusable medical device (RMD)

For the present guidlelines reusable medical device (RMD) means:

  • an item that is not intended by its manufacturer for single use.
  • A medical device designated or inrtended by the manufacturer as suitable for reprocessing.

The reprocessing of single use medical device is outside the scope of theses guidelines.
Medical device regulations vary between regions. Some items may not be registered as medical devices in some regions.

Sterilization

Sterilization is intended to renders the reusable medical device free from viable microorganisms. Sterilization is implemented on a clean RMD. Most common Sterilization process is steam. Low temperature sterilization processes are available for heat sensitive RMD

Disinfection :

Process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose (ISO 11139 : 2018) 

Cleaning :

Removal of contaminants to the extent necessary for its further processing or for intended use (ISO 11139 : 2018)  

Other definition: The first step required to physically remove contamination by foreign material, e.g. dust soil. It will also remove organic material such as blood, secretion, excretion and microorganisms, to prepare a medical device for sterilization or disinfection (WHO : 2016) 

Cleaning may be combined to disinfection in cleaning & disinfections processes (for instance in automated washer-disinfectors)

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Sterilization :

Process used to render product free from viable microorganisms (ISO 11139 : 2018)

  • courthouse-3-1 Sterilization is intended to renders the reusable medical device (RMD) free from viable microorganisms.

Reusable Medical device (RMD) 

Medical devices wich are not single use i.e. which can be reused under appropriate reprocessing conditions, for an undelimited number of time or for a predetermined number of use.