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Standards & regulation

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Standards, regulation and guidelines

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

  1. Regulation: Medical device regulations (including reprocessing aspects) are published by govermental bodies. They can be national like in the USA1 or supra-national like in the European Union2. Regulatory texts are of compulsory application. Present WFHSS guidelines will not comment regulation.
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Common regulatory requirements for device reprocessing include obligations for medical device manufacturers to provide detailed reprocessing instructions, ensuring safe and effective reuse. Hospitals are also mandated to report any incidents involving medical devices, including those related to reprocessing failures. Additionally, national regulations often structure sterilization practices by setting specific requirements, such as the need for authorization to establish a sterilization department, defined qualifications for personnel managing a Central Sterile Services Department (CSSD), and rules governing the frequency and procedures for auditing sterilization processes.

  1. Standards set common expectations on products, services or processes to facilitate trade and enhance confidence and safety. They result from a consensus between experts representing their country. They are generally of voluntary application although some can be made compulsory by local regulation.
  • Standards can be multiregional in scope (ISO), regional (CEN for the European Union) or national (DIN, BS etc..).
  • Governing bodies define which standards are applicable. They may decide to not endorsed an ISO standard. Conversely Non EU nations can make the choice to use EN standards
  • Standards can be specific to a given category of product or processes (e.g. steam sterilization) or transversal (e.g. Quality Management)
  • Standards are subject to copyright and fees. Revenus generated by the sales of standards are used to finance the standardization effort
  • While many international standards exist, they do not cover all products or processes. For example, highly innovative concepts or niche products may not justify the effort required for standardization, and achieving multiregional consensus may be challenging.
  • When available, standards are advantageous for manufacturers, end users, and regulatory authorities. For instance, if compliance with a specific standard is specified in a tender, it becomes binding for all

Sterilization and disinfection standards come in support of applicable medical device regulation but do not supersede it.

iso

In the case of the European Union, the compliance to an harmonized standard (i.e. a standard endorsed by the EU) indicates that the essential requirements of the medical device regulation are met and are used by notified bodies who audit manufacturers, for CE marking.

The present chapter will give an overview of international sterilization and disinfection standards (ISO and CEN) but will not comment on national standards (i.e. those applicable in only one country or a limited number of nations).

  1. Guidelines provide best practice recommendations (there are also called best practice or recommened practices).They take into applicable regulation and standards and serve as a framework for education programs.

Sterilization guidelines are many and diverse:

  • They can be multi-regional (e.g., WFHSS), regional, or most commonly, national..
  • Guidance may encompass all reprocessing steps or sterilization methods within a single document (e.g., WFHSS) or be segmented across multiple documents, as with AAMI’s recommended practices.
  • Guidelines are access free (like WFHSS) or subject to fees. Links to access free national or international guidelines are provided under the international guidelines tab of WFHSS guidelines homepage.
  • A variety of organizations contribute to sterilization guidelines, including scientific societies focused on sterilization or hygiene, medical or nursing societies, standards organizations, and sometimes governmental bodies, either by creating or endorsing existing guidelines.
  • WFHSS guidelines are intended to encourage progressive alignment on evidenced based device reprocessing best practices for health care facilities. They do not supersede locally applicable guidelines if they exist.
  • The interactive format allows adaptation to local needs (via the “show more” function) and a growing number of local languages (as artificial Intelligence improves translation)
  • WFHSS acknowledges that there are different ways to achieve the same outcomes in terms of patient safety and environment friendliness. For example, there is a consensus to avoid drying of soil before cleaning but there are different opinions on how this is best achieved
  • The above classification (regulation, standards, guidelines) is proposed for convenience and not universal or official. Borders between regulation, standards and guidelines are subject to local interpretation. For example, guidelines may be considered as part of the regulatory framework when they are endorsed by governmental bodies.
  • In case of overlaps, regulation will always supersede standards and guidelines.
  • The combination of regulation and the most recent standards and guidelines will constitute the state of the art in case of legal dispute.

International sterilization and washer-disinfector Standards

International ISO and EN standards are written by experts nominated by their national delegations.

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Process for Proposing and Developing a New Standard

  • Proposal Submission:
    Proposals for new standards can be submitted through a national delegation or by ISO or CEN technical committees.
  • Approval of New Work Item (NWI):
    Once the scope of a new work item (NWI) is approved by a vote, the project is assigned to a working group for development.
  • Drafting and Initial Review:
    The first draft is typically created by the project initiators and then distributed to national committees for feedback. Comments are reviewed and discussed in meetings of working group experts.
  • Iterative Review and Consensus:
    The standard usually undergoes multiple rounds of drafting, voting, and review to reach a consensus. Performance testing may be required to establish and align on specific performance thresholds.
  • Final Approval and Periodic Review:
    Once the text is finalized and approved, the standard is published. Every three years, member countries are asked whether they wish to confirm, modify, or withdraw the standard

A graphic representation of ISO and CEN sterilization standards of interest to healthcare facilities can be accessed via this link:  Download PDF

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Radiation standards (not commonly used) in healthcare facilities and aseptic reprocessing (mainly intended for industry) are not displayed or commented in the following pararaphs

Normative or informative
  • Normative sections or annexes within international standards include requirements that are essential for compliance claims, regulatory inspections, or certification assessments.
  • Informative sections or annexes support the normative content without altering its requirements. Notes within normative sections are also informative and do not modify the normative requirements.
  • Documents labeled as ISO/TS (Technical Specifications) are informative in nature. They provide guidance for implementing standards or consolidate information applicable to multiple standards (e.g., water quality standards for washer-disinfectors and sterilizers).
Healthcare Facilities and Industry in Sterilization Standards
  • International sterilization standards apply to the reprocessing of medical devices in both healthcare facilities and industry settings.
  • Normative requirements must be consistent across both domains, despite their significant differences. For example, industry typically processes homogeneous loads (e.g., identical single-use items with controlled initial contamination levels), whereas healthcare facilities often handle heterogeneous loads (e.g., diverse devices with varying contamination levels, even after thorough cleaning).

Terms and definition used by all sterilization standards are compiled in ISO 111393. For convenience each standard defines the normative terms used by the standard.

Some standards contain requirements for all categories of stakeholders involved in device reprocessing i.e. healthcare facilities, manufacturers of reprocessing equipment or consumables, as well as manufacturers of medical devices and various service providers. This is the case of the ISO sterilization process standards (ISO 17665 for steam4 , ISO 22441 for low temperature vaporized hydrogen peroxide5, ISO 11135 for ethylene oxide6, ISO 25424 for low temperature steam and formaldehyde7, ISO 20857 for dry heat8, ISO 149379 for sterilization technologies which do not have a dedicated standard).

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Sterilization process standards have a common structure inspired by ISO 14937. They include a foreword, an introduction,12 normative paragraphs and a variable number of normative or informative annexes.

Sterilization standards do not assign responsibilities (i.e. who is responsible for compliance to each normative requirements). However typical task ownerships may be described in an informative annex included in the standard or referring to Annex E (paragraph 4 of ISO 14937).

  • Foreword: reminds ISO principles
  • Introduction: provides general information on the purpose of the standard, sterility assurance and quality management principles. It reminds that process standards apply to healthcare facility and medical device manufacturing domains.
  1. Scope defines what is covered and not covered by the standards (inclusions and exclusions) and who are the potential users of the standard. Prion inactivation is outside the scope of ISO sterilization standards as no standardized methods exist yet for prion protein (although internationally recognized methods exist and some processes such as some H2O2 LTS cycle are effective).
  2. Normative reference lists the published standards to which the process standard refers
  3. Terms and definition gives the definition of standardized terms used by the process standards. When needed informative notes are added after the ISO 111393
  4. Quality management system reminds high level quality management guidance for all organizations concerned by the standard.
  5. Sterilization agent characterization concerns the evaluation of microbial efficacy, impact on properties and biological safety of materials after exposure. Compliance is in the hands of the sterilizer manufacturer. Supporting evidence comes from scientific peer reviewed literature and experiments run by the sterilizer manufacturer. The healthcare facility reviews the information provided by the sterilizer manufacturer.
  6. Process and equipment characterization. Each process standard lists process and cycle variables that must be measured. 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) while pressure is a cycle variable. The parameters (with tolerances) are the value of the variables. The sterilizer manufacturer owns compliance and defines the parameters (values range) for each variable and means by which those parameters are controlled and monitored. The healthcare facility reviews the information provided by the sterilizer manufacturer.
  7. Product definition means the load of devices or set of devices adequately adequately cleaned, organized and packaged. This task is owned by the healthcare facility who checks sterilization modality and cycle is approved by the medical device manufacturer (MDM) and writes the cleaning, control and assembly, packaging and sterilization procedure in accordance with the instructions for reprocessing that provided and validated by the MDM (see below).
  8. Process definition pertains to the reprocessing instructions for a given medical device. The definition and validation of reprocessing instructions (from point of use reprocessing to sterilization) is owned by the medical device manufacturer (MDM). Concerning sterilization. the MDM verifies that a given medical device can be sterilized and remains safe and functional after repeated reprocessing for each modality and cycle specified in the IFU. The MDM often partners with the sterilizer manufacturer or third parties but remains responsible for reprocessing instructions. Medical devices may be grouped by product families to reduce the number of tests but the grouping must be justified.
  9. Validation means the verification that sterilization operations give the expected results. Compliance is owned by the healthcare facility. The latter may contract with sterilizer manufacturer for installation qualification (IQ) and operational qualification (OQ) and, with the sterilizer manufacturer or third party, for performance qualification (PQ). The healthcare facility must however validate and sign all qualification reports.
  10. Routine control and monitoring encompass all daily or periodic verifications. Compliance is owned by the healhtcare facility. Process standards require the control, monitoring and recording of cycle parameters but do not impose the use of BI’s and CI’s. Guidance or obligation related to CI and BI usage depend on the sterilization technology and country.
  11. Product release from sterilization. Release modalities (i.e., procedures to allow the use of sterilized product on patient) are country and modality dependent and in accordance with 10. The release may be only Parametric (i.e., based on records demonstrating that the sterilization process variables were delivered within specified tolerances) or on a combination of periodic or systematic BI and/or CI verification. Compliance is owned by the healthcare facility in accordance with locally applicable guidance or obligations.
  12. Maintaining process effectiveness means the measures that must be implemented to ensure that the sterilization process continues to perform as intended. Compliance is owned by the healthcare facility. The latter will contract with the sterilizer manufacturer for maintenance, operational requalification, performance requalification or qualified third parties for performance requalification. Requalification intervals are not defined by process standards but, in practice, is often annual.

Other CEN and ISO standards are mainly intended for Manufacturers of sterilization equipment, washer-disinfectors, biological and chemical indicators, packaging or various service activities. They may however contain some requirements or guidance useful to healthcare facilities, for example to establish tender specifications, validate washer reprocessors process, select and validate packaging processes.

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Sterilizer standards

The EN sterilizers standards for steam 10,11, ethylene oxide 12, low temperature steam and formaldehyde 13 , low temperature H2O2 (work in progress) 14, specify requirements and relevant type and works tests. They are used by manufacturers to verify compliance to requirements, by applying type tests, or to implement works test (verifications before delivery). EN sterilizer standards can also be of interest to healthcare facilities to establish tender specifications.

EN sterilizer standards are complementary  to ISO sterilization process standards. For example, ISO process standards provide high level objectives for equipment characterization while EN sterilizer standards detail technical requirements, corresponding test methods and acceptance criteria.

ISO/TS 2242115 (guidance) set common requirements for all sterilizers used in healthcare facilities. All EN sterilizer standards are or will be reorganized according to the table of contents of ISO 22421.

Washer-disinfectors

ISO standards for thermal and chemical washer-disinfectors16,17,18,19,20,21 are primarily intended for manufacturers but they also contain detailed guidance for validation and routine controls by the healthcare facility.

ISO 15883-522 describes test method and criteria to control cleaning efficacy during type testing by manufacturers of washer-disinfectors and process validation by healthcare facilities.

EN 1644223 specify the test method and criteria for equipment used to store heat sensitive flexible endoscopes between uses. The maximum allowed storage period and validation modalities and validation frequency are defined by local regulation or guidelines.

Biological and chemical indicators

ISO 11138-1 describes the general type test and acceptance criteria for biological indicators24, while ISO 11138-2 to ISO 11138-6 25,26,27,28,29 add specific test and acceptance criteria for each sterilization modalities, ISO 11138-730 contains guidance for implementation of BI tests and interpretation of results. ISO 11138-831 defines the method to validate a reduced incubation time (i.e. shorter than 7 days).

ISO 11140-132 contains the general requirements and test method for chemical indicators (CI) and defines the various types of CI (1 to 6 according to the number of process variables that they take into account). ISO 11140-3,-4,-5 33,34,35 focus on type 2 chemical indicators for steam sterilization processes. ISO 11140-6 standardizes a type test BI and challenge device for small steam sterilizers36 , it corrects the weaknesses of EN 867-5.

ISO 1847237 describes the test equipment (resistometers) used for evaluation of BI and CI.

Type

 Name Description (the classification from 1 to 6 has no hierarchical significance)
1 Process indicator Intended for use with individual units (packs or containers) to distinguish between processed and unprocessed units. Type 1 indicator are usually included in packaging or packaging accessories.
2 Indicators for use in specific tests Intended for use in specific test procedures, such as, the Bowie- Dick test for air removal in steam sterilizer pre-vacuum cycles. Various type of Bowie and Dick type indicators are described by international standards/ ISO 11140-3 to ISO 11140-6
3 Single variable indicators React to one of the sterilization variables, e.g. time and temperature, and are intended to indicate exposure to a predetermined sterilization process variable, e.g. 134°C
4 Multivariable indicators React to two or more of the sterilization variables, e.g. time and temperature, and are intended to indicate exposure to predetermined sterilization process variables, e.g. 134°C, 3 minute
5 Integrating indicators React to all variables of the sterilization process, e.g. time, temperature and presence of moisture, and are intended to be equivalent to or exceed the performance requirements given in the ISO 11138 series (see below) for biological indicators
6 Emulating indicators

React to all critical variables of the sterilization process, e.g. time, temperature and presence of moisture, and are intended to match the variables of specified sterilization cycles

 

Packaging

ISO 11607-138 gives the general requirements and test methods for packaging systems while ISO 11607-239 focuses on validation of packaging processes. ISO/TS 1677540 provides comprehensive guidance on ISO 11607-1 and ISO 11607-2. EN packaging standards EN 868-2 to -1041 detail ISO  test methods and criteria for each type of packaging and/or material (wraps, paper bags, sealable pouches and reels, paper and adhesive coating for LTS, reusable containers)

Information provided by Medical Manufacturers

ISO 17664-142 and ISO 17664-2 43, respectively, specify requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices.

 

Microbiological methods

Microbiological methods standards give requirements and guidance for controls performed on medical devices, raw materials or packages

  • Enumeration and microbial characterization of microorganisms: ISO 11737-144
  • Tests of sterility at reduced treatment (for example ½ cycle test) for validation of sterilization processes ISO 11737-2,45. In practice, in healthcare facilities validation are performed with biological indicators instead of contaminated devices
  • determination of bacterial endotoxins on or in health care products, components or raw materials: ISO 11737-346.

Water quality

ISO/TS 511147 provides guidance on the quality of water for sterilizers, sterilization and washer-disinfectors (WDs)

International Sterilization and washer-disinfectors standards frequently refer to other international standards, under the responsibility of other ISO or IEC committees. For example:

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

Disinfection standards

Unlike for sterilization, there are no 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 the USA.
  • Both EN and AOAC and ASTM, in some cases with adaptations, like in Australia.

Unlike sterilization, where tests focus exclusively on microorganisms predetermined to be the most resistant to the specific sterilization process, disinfection claims are validated across multiple categories of microorganisms with varying resistance levels. These categories include bacteria, fungi and yeast, viruses (both enveloped and non-enveloped), mycobacteria, and spores.

Efficacy targets are expressed in log reduction (instead of Sterility Assurance Level for sterilization). The log reduction to be achieved may differ between categories of microorganisms and region.

Known levels of resistance to disinfection and sterilization processes is as follows

    Resistance

  • Prion protein
  • Bacterial spores
  • Mycobacteria
  • Fungal spores
  • Gram-negative bacteria
  • Non-enveloped viruses
  • Gram positive bacteria

Disinfectants are commonly grouped in three levels: low, intermediate and high. However, the definitions and limits of the categories are not universally agreed upon.

For example, a commonly used definition for High Level Disinfectant (HLD) is: a germicide that inactivates all microbial pathogens, except large numbers of bacterial endospores (Rutala 1990, Spaulding 1970). HLD means some level of efficacy on spores, but test method and efficacy thresholds are country or region dependent.

  • For the US FDA, the definition for a high-level disinfectant is: a “sterilant” used for a shorter contact time to achieve a 6-log10kill of an appropriate Mycobacterium species. Note that, for ISO, sterilant has a different meaning (a sterilant is the liquid solution that is vaporized to become a sterilizing agent, (e.g., in H2O2 low temperature processes, the liquid H2O2 solution is the sterilant and vaporized H2O2 the sterilizing agent)
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The sterilant concept is specific to US FDA and based upon AOAC 966.0454.

Demonstration of sterilant capabilities requires a total of 720 carriers (360 penicyclinders and 360 silk sutures loops) containing > 6 log of spores of Bacillus subtilis or Clostridium sporogenes on each. Three different lots of the chemical are evaluated (120 penicylinders and 120 suture loops per lot).

All 720 carriers must be negative after a pre-defined exposure time longer than the exposure time recommended for routine use.

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 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.

Formulations may be used at “sterilant” concentration and referred to as “liquid sterilization”. It must however be kept in mind that liquid sterilant application will be followed by a rinsing and unlike in terminal sterilization the device is not protected by a sterile barrier system.  Terminal sterilization is the preferred modality for critical devices

  • Australia TGA high-level disinfectant is not necessarily a “sterilant” according to FDA but also use qualitative tests inspired by FDA.
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At the labelled exposure time, there must be no more than two 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

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

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EN 14885:2018 specifies testing methods applicable across sectors such as human medicine, veterinary medicine, food production, industry, domestic environments, and institutional settings.

Within the medical field, EN 14885 outlines specific test methods adapted to various applications: hand hygiene, surface disinfection, textile disinfection, aqueous systems, and instrument disinfection.

For instrument disinfection, EN 14885 provides suspension-based methods (phase 2, step 1) and carrier-based methods (phase 2, step 2). Carrier tests (phase 2, step 2) are particularly relevant for medical devices, as they better represent real-life conditions and align more closely with AOAC and ASTM methodologies.

To simulate real-use conditions, interfering substances are added to microorganisms, representing either ‘clean’ or ‘dirty’ conditions depending on the application. This substance protects the microorganisms during inoculum preparation, ensuring viability during inoculum drying.

Tests are conducted at the concentration and exposure time specified by the manufacturer. At the end of the exposure time, a neutralizer is applied to halt biocidal activity, after which a microbial count is performed to confirm that the target log reduction has been achieved.

Claim Phase 2 Step 1
Suspension		 Phase 2 Step 2
Carrier
Bactericidal activity EN 1372762 EN 1456167
Yeasticidal EN 1362463 EN 1456268
Fungicial EN 1362463 EN 1456268
Tuberculocidal EN 1434864 EN 1456369
Mycobactericidal EN 1434864 EN 1456369
Virucidal against enveloppe viruses EN 1711170
Virucidal EN 1447665 EN 1711170
Sporicidal against Clostridium difficile. EN 1712666
Sporicidal EN 1712666

Detergent

There are currently no international standards specifically for evaluating detergent efficacy. However, the effectiveness of the overall cleaning process (i.e., the combination of mechanical, thermal, and chemical actions) can be assessed according to ISO 15883-522. This standard recommends specific analytes (chemical substances that can be collected from the surfaces of medical devices after cleaning) to measure cleaning efficacy.

ISO 15883-5 defines ‘alert’ and ‘action’ levels for each analyte, expressed in µg of analyte per cm² of device surface. The ‘alert’ level serves as an early indication of potential deviations in the cleaning process, while the ‘action’ level indicates the need for corrective measures, such as addressing process failures or device damage that may promote soil or biofilm accumulation.

For example, with the reference analyte ‘residual protein’ specified in ISO 15883-5, the alert and action levels are 3 µg/cm² and 6.4 µg/cm², respectively. Some countries, like the UK, measure residual soil per device side and may set different threshold values.

Additionally, ISO 15883-5 suggests artificial test soils representative of real-life contaminants for specific medical or surgical procedures (e.g., coagulated blood for general surgery or flexible endoscopy). Other artificial test soils may be proposed, provided they are benchmarked against standardized references.These analytes, test soils and corresponding thresholds are used by manufacturers of washer-disinfectors, medical device and end-users for process validation.

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Although ISO 15883-5 was developed to evaluate automated cleaning processes, it could also be applied to manual processes. However, a limitation for manual processes is their dependency on operator technique, which can introduce variability in outcomes.

Synthesis: standards for terminal sterilization, disinfection and detergent

The graph below summarizes the key differences among terminal sterilization, disinfection, detergents, and prion inactivation from a regulatory and normative perspective:

  • Prion Inactivation: No ISO standards currently exist for prion inactivation. However, internationally recognized in vivo and in vitro methods are available for evaluating efficacy.
  • Disinfection: There are no ISO standards for disinfection. Efficacy evaluations and claims are based on categories of microorganisms, with test methods varying by region or country. While the underlying principles are similar, the specific test methods and efficacy thresholds for high-level disinfection are regionally specific. For example, the United States FDA requires high-level disinfectant formulations to function as a “sterilant” when used for extended exposure times.
  • Terminal Sterilization: Defined by ISO standards, terminal sterilization evaluations include determining the most resistant microorganism and performing sterility assurance tests. These evaluations use methods tailored to the application (e.g., the “overkill” method in hospital settings).
  • Detergents: There are no ISO standards specifically for detergent efficacy evaluation. However, the effectiveness of the cleaning process (involving mechanical, thermal, and chemical actions) can be benchmarked using methods and thresholds provided in ISO 15883-5.

A graphic representation of Synthesis: standards for terminal sterilization, disinfection and detergent via this link: Download PDF

WFHSS recommendations for regulation, standards and guidelines

  1. Sterilization training and practices are governed or guided by international and/or regulation, standards and guidelines.
  2. Regulations are country or region-specific. In cases of overlap, applicable country regulations take precedence over standards and guidelines.
  3. International sterilization and washer-disinfector standards establish common expectations to facilitate trade and build confidence. ISO standards exist for terminal sterilization across multiple regions, though not yet for disinfection. Cleaning processes can, however, be benchmarked against ISO 15883-5.
  4. Guidelines are developed with consideration of applicable regulations and standards, providing a framework for education and training. WFHSS guidelines aim to promote alignment with evidence-based best practices.

Bibliographic references – Regulation, standards and guidelines

  1. Title 21 CFR parts 800-1299
  2. Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 on medical devices
  3. ISO 11139: Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards (2018)
  4. ISO 17665: Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices (2024)
  5. ISO 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) (2022)
  6. 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)
  7. 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)
  8. ISO 20857: Sterilization of health care products – Dry heat – requirements for development, valudation and routine control of a steriization process for medical devices (2010)
  9. 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)
  10. EN 285: Sterilization – Steam sterilizers – Large sterilizers (2016)
  11. EN 13060: Sterilization – Steam sterilizers – Small steam sterilizers (2018)
  12. EN 1422: Sterillizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods (2014)
  13. EN 14180: Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – requirements and testing (2014)
  14. prEN 17180: Sterilizers for medical purposes – Low temperature vaporized hydrogen peroxide sterilizers – requirements and testing (Work In Progress)
  15. ISO/TS 22421: Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities (2021)
  16. ISO 15883-1 : Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (2006)
  17. 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)
  18. ISO 15883-3 : Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (2006)
  19. ISO 15883-4 : Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (2018)
  20. 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)
  21. 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)
  22. ISO 15883-5: Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (2021)
  23. EN 16442: Controlled environment storage cabinet for processed thermolabile endoscope (2015)
  24. ISO 11138-1 Sterilization of health care products — Biological indicators — Part 1: General requirements (2017)
  25. ISO 11138-2 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (2017)
  26. ISO 11138-3 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for moist heat sterilization processes (2017)
  27. ISO 11138-4 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes (2017)
  28. ISO 11138-5 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (2017)
  29. ISO/AWI 11138-6 Sterilization of health care products — Biological indicators — Part 6: Biological indicators for hydrogen peroxide sterilization processes (Work In Progress)
  30. ISO 11138-7 Sterilization of health care products — Biological indicators — Part 7: guidance for the selection, use and interpretation of results (2019)
  31. ISO 11138-8 Sterilization of health care products — Biological indicators — Part 8: Method for validation of a reduced incubation time for a biological indicator (2021)
  32. ISO 11140-1: Sterilization of Health care products – Chemical indicators – Part 1: General requirements (2014)
  33. 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)
  34. 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)
  35. 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)
  36. 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
  37. ISO 18472: Sterilization of Healthcare products – Biological and chemical indicators – Test equipments (2018)
  38. ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (2019)
  39. ISO 11607-2: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (2019)
  40. ISO 16775: Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2 (2021)
  41. EN 868-2 to 10 Packaging for terminally sterilized medical devices – Part 2 to 10.
  42. 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)
  43. 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)
  44. ISO 11737–1: Sterilization of health care products – Microbiological method – Part 1: Determination of a poluplation of microorganisms onproducts (2018)
  45. 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)
  46. ISO 11737–3: Sterilization of health care products – Microbiological method – Part 3: bacterial endotoxin testing (2023)
  47. ISO/TS 5111: Quality of water for sterilizers, sterilization and washer-disinfectors (work in progress)
  48. ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes (2016)
  49. ISO 14971: Medical devices – Application of risk management to medical devices (2019)
  50. 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)
  51. ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (2018)
  52. ISO 10993-7 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (2019)
  53. ISO 10993-17 Biological evaluation of medical devices – Part 7: Establishment of allowable limits for leachable substances (2002)
  54. AOAC 966.04, Sporicidal Activity of Disinfectants (2002)
  55. AOAC 965.12-1967, Tuberculocidal activity of disinfectants (2008)
  56. AOAC 955.17, Fungicidal activity of disinfectants. Using trichophyton mentagrophytes (1995)
  57. AOAC 955.14, Testing disinfectants against salmonella (2013)
  58. AOAC 955.15-1959, Testing disinfectants against staphylococcus aureus (2009)
  59. AOAC 964.02-2012 Testing Disinfectants Against Pseudomoans aeruginosa (2012)
  60. ASTM E2197 Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
  61. EN 14885 Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics (2022)
  62. 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)
  63. 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)
  64. 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)
  65. 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)
  66. 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)
  67. 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)
  68. 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)
  69. 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)
  70. 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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