93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

This document specifies general requirements for the design of tests for identifying and quantifying
degradation products from final metallic medical devices or corresponding material samples finished
as ready for clinical use.
This document is applicable only to those degradation products generated by chemical alteration of the
final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results
approximate the in vivo behaviour of the implant or material. The described chemical methodologies
are a means to generate degradation products for further assessments.
This document is applicable to both materials designed to degrade in the body as well as materials that
are not intended to degrade.
This document is not applicable to evaluation of degradation which occurs by purely mechanical
processes; methodologies for the production of this type of degradation product are described in
specific product standards, where available.
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the
scope of this document, such degradation products can evoke a biological response and can undergo biological
evaluation as described in other parts of ISO 10993.
Because of the wide range of metallic materials used in medical devices, no specific analytical
techniques are identified for quantifying the degradation products. The identification of trace elements
(<10–6 w/w) contained in the specific metal or alloy is not addressed in this document, nor are specific
requirements for acceptable levels of degradation products provided in this document.
This document excludes the biological activity of the degradation products. (See instead the applicable
clauses of ISO 10993-1 and ISO 10993-17).

2022-06-21 - lack of compliance - publication on hold

This document specifies the performance requirements of instruments as used in the NON -
INVASIVE MEASUREMENT of X- RAY TUBE VOLTAGE up to 150 kV and the relevant compliance tests.
This document also describes the method for CALIBRATION and gives guidance for estimating
the uncertainty in measurements performed under conditions different from those during
CALIBRATION .
Applications for such measurement are found in diagnostic RADIOLOGY including mammography,
COMPUTED TOMOGRAPHY (CT), dental radiology and RADIOSCOPY . This document is not
concerned with the safety aspect of such instruments. The requirements for electrical safety
applying to them are contained in IEC 61010-1.

IEC 61676:2023 is available as IEC 61676:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61676:2023 specifies the performance requirements of instruments as used in the non-invasive measurement of X-RAY tube voltage up to 150 kV and the relevant compliance tests. This document also describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. Applications for such measurement are found in diagnostic radiology including mammography, computed tomography (CT), dental radiology and radioscopy. This document is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1. IEC 61676:2023 cancels and replaces first edition published in 2002, Amendment 1:2008. This edition constitutes a technical revision. It includes an assessment of the combined standard uncertainty for the performance of a hypothetical instrument for the non-invasive measurement of the tube high voltage (in Annex A) which replaces Annex A of the edition 1.1 titled "Recommended performance criteria for the invasive divider".

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
—    details of in vivo skin sensitization test procedures;
—    key factors for the interpretation of the results.
NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

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20211012-JO-Link to 93/42/EEC and M/295 removed

IEC 60118-13:2019 covers the relevant EMC phenomena for hearing aids. Hearing aid immunity to high frequency fields originating from digital wireless devices such as mobile phones was identified as one of the most relevant EMC phenomena impacting hearing aids. IEC 60118-13:2019 cancels and replaces the fourth edition published in 2016 and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) it introduces a new measurement method and set of EMC requirements for hearing aids immunity to mobile digital wireless devices; b) generic EMC requirements for hearing aids are no longer included – should be covered by other standards as appropriate.

IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) revision of the definition about ESSENTIAL PERFORMANCE; b) revision of the application of IEC 60601-1-2:2014 for electromagnetic disturbances; c) correction of the used voltage for HEARING AIDS from 1,6 V to 4,5 V; d) correction of the drop test level from 1,5 m to 1,0 m; e) correction of the wording of IEC 60601-2-66:2015.

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
—    details of in vivo skin sensitization test procedures;
—    key factors for the interpretation of the results.
NOTE      Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

2022-06-21 - lack of compliance - publication on hold

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:
- equipment for RADIOTHERAPY;
- equipment for COMPUTED TOMOGRAPHY;
- ACCESSORIES intended to be introduced into the PATIENT;
- mammographic X-RAY EQUIPMENT;
- dental X-RAY EQUIPMENT.
NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA.
NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements.
NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 203.6.4.5).
INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard.
If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.
NOTE 4 See also 4.2 of the general standard.
The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.

This document specifies general requirements and test methods for assistive products, considered to be medical devices, intended for use to alleviate or compensate for a disability.
This document does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.
NOTE 1    Assistive products are considered to be medical devices in some jurisdictions but not in others.
NOTE 2    Requirements and test methods for particular types of assistive products are given in other International Standards, e.g. see Reference [33].
NOTE 3    Not all the items listed in ISO 9999 are medical devices. Contracting parties might wish to consider if this document or specific clauses or subclauses can be used for assistive products that are not medical devices.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular: - equipment for RADIOTHERAPY; - equipment for COMPUTED TOMOGRAPHY; - ACCESSORIES intended to be introduced into the PATIENT; - mammographic X-RAY EQUIPMENT; - dental X-RAY EQUIPMENT. NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA. NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements. NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 203.6.4.5). INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard. If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 4 See also 4.2 of the general standard. The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.

This International Standard specifies the performance requirements and test methods for chemical indicators and hollow devices and porous devices within which they are intended to function, to be used for testing the steam penetration performance of type B cycles of small steam sterilizers; small steam sterilizers are defined in EN 13060. The hollow and porous devices described in this standard do not substantiate their suitability as surrogate devices for lumened, hollow and porous medical devices used in health care facilities.
Chemical indicators used with a porous device specified in this standard are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060).
The relevant sections of this International Standard covering porous loads specify the requirements for
— a reference porous device to be used in the small load test for porous loads in small steam sterilizers and as a reference device by which alternative porous devices can be shown to be equivalent in performance according to this standard; ie, a textile test pack in which steam penetration is judged by thermometric means;
— an alternative porous device equivalent in performance to the reference porous device; ie, an alternative porous device, usually commercially manufactured, of any design.
Chemical indicator systems used with a hollow load device specified in this standard are designed to demonstrate the adequacy of steam penetration into a hollow device in small steam sterilizers (see EN 13060).
The relevant sections of this International Standard covering hollow loads specify the requirements for
— a reference hollow device used as a reference device in this standard; ie, a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator;
— an alternative hollow device employing the same specific test load as defined for the reference hollow device and an indicator system designed specifically for use in the reference hollow test load; ie, a lumened device with an attached capsule in which steam penetration is judged by visual examination of an indicator system;
— an alternative hollow device equivalent in performance to the reference hollow device; ie, an alternative hollow device, usually commercially manufactured, of any design.

IEC Corrected version

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

IEC Corrected version

This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:
—    intended for use in the home healthcare environment;
—    intended for use by a lay operator;
—    intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and
—    intended for transit-operable use.
NOTE       An infant cardiorespiratory monitor can also be used in professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.
EXAMPLE        probes, cables distributed alarm system

This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060.
NOTE      The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities.
a)    Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060).
This document specifies the requirements for:
—    a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means;
—    an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design.
b)    Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060).
This document specifies the requirements for:
—    a reference hollow device (RHD) used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator;
—    an alternative hollow device:
—    employing the same specific test load as defined for the RHD and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator;
—    equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.

This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.
This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation.
This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility).
EXAMPLE   Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document.
This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document.
This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

IEC 60601-2-46:2010 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the table top to or from the base or pedestal of an operating table with detachable table top. This second edition cancels and replaces the first edition published in 1998 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1.

IEC 61223-3-5:2019 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD1:2012AMD2:2016. IEC 60601-2-44 and this document • defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 4.3, • defines the methods of testing the essential parameters, and • evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS. The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER. This document does not apply to • aspects of mechanical and electrical safety, and • aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning. IEC 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition and to IEC 61223-2-6: 1) modification of the RADIATION protection and control; 2) modification of the acceptance testing; 3) introduction of constancy testing.

This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:
—    intended for use in the home healthcare environment;
—    intended for use by a lay operator;
—    intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and
—    intended for transit-operable use.
NOTE       An infant cardiorespiratory monitor can also be used in professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.
EXAMPLE        probes, cables distributed alarm system

This device-specific standard specifies requirements for nasal cannulae used in both home-care and hospital environments for the administration of oxygen therapy.

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2017-10-09: Publication on hold due to negative assessment

IEC 80601-2-59:2017 applies to the basic safety and essential performance of screening thermographs intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME equipment. This document sets laboratory characterization test limits for the screening thermograph. This edition includes the following significant technical changes with respect to the previous edition: a) updates of the normative references and the bibliography; b) expansion of the applicability to pandemic infectious diseases in general.

TThis document specifies requirements and test methods for electrically powered wheelchairs, with a maximum speed not exceeding 20 km/h, intended to carry one person of mass not greater than 300 kg, including:
-   electrically powered scooters with three or more wheels,
-   manual wheelchairs with an add-on drive system,
-   handrim-activated power-assisted wheelchairs,
-   electrically powered stand-up wheelchairs,
-   balancing wheelchairs,
-   wheelchairs with a pivot drive wheel unit, and
-   assistant-guided wheelchairs.
This document does not apply to custom-made electrically powered wheelchairs or electrically powered wheelchairs intended for use in sports.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

This document specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not greater than 250 kg, including:
—   stand-up manual wheelchairs, and
—   manual wheelchairs for showering and/or toileting.
This document does not apply to custom-made manual wheelchairs or manual wheelchairs intended for use in sports.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

This document specifies requirements and test methods for manual wheelchairs intended to carry one person of mass not less than 25 kg and not greater than 250 kg, including
- stand-up manual wheelchairs, and
- manual wheelchairs whose intended use includes showering and/or toileting.
This document does not apply to custom-made manual wheelchairs, manual wheelchairs intended for use in sports, or manual wheelchairs intended only for showering and/or toileting.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

This document specifies requirements and test methods for electrically powered wheelchairs, with a maximum speed not exceeding 20 km/h, intended to carry one person of mass not less than 25 kg and not greater than 300 kg, including
- electrically powered scooters with three or more wheels,
- manual wheelchairs with an add-on electrically powered drive system,
- handrim-activated power-assisted wheelchairs,
- electrically powered stand-up wheelchairs,
- wheelchairs with a pivot drive wheel unit, and
- push-assist wheelchairs.
This document does not apply to balancing wheelchairs, custom-made electrically powered wheelchairs or electrically powered wheelchairs intended for use in sports.
This document also specifies requirements and test methods for manual wheelchairs with electrically powered ancillary equipment.

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IEC Corrected version

This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy.
This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.

This document specifies a test method and the minimum requirements for the microbicidal activity of a defined disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as defined in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers instructions shall be sufficient to allow the method in the standard to be carried out fully (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C). This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: — in hospitals, in community medical facilities, and in dental institutions; — in clinics of schools, of kindergartens, and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients. The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product. NOTE This method corresponds to a phase 2, step 2 test (see EN 14885). EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

This European Standard specifies general requirements and test methods for assistive products for persons with a disability, which are medical devices according to the definition laid down in the EU Directive 93/42/EEC.
This European Standard does not apply to assistive products which achieve their intended purpose by administering pharmaceutical substances to the user.
Where other European Standards exist for particular types of assistive products then those standards apply. However, some of the requirements of this standard may still apply and may be considered in addition to those in other European standards.
NOTE   Not all the items listed in EN ISO 9999 are medical devices. Contracting parties may wish to consider if this standard or parts of this standard can be used for assistive products which are not medical devices as defined in the EU Directive 93/42/EEC.

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

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IEC 60601-2-75:2017 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document applies to photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability. In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area), such equipment also comply with any particular standard specifying safety requirements for the additional function. This particular standard does not apply to: - light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia; - low-level laser therapy equipment not intended for use with a photosensitizer; - illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a photosensitizer. This document is to be used with IEC 60601-1:2005 and its amendment 1.

IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment. The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units. For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient. This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply. This document does not apply to implantable parts of multifunction patient monitors. This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8.

IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.

This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C).
This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities, and in dental institutions;
- in clinics of schools, of kindergartens, and of nursing homes;
and could occur in the workplace and in the home.
It could also include services such as laundries and kitchens supplying products directly for the patients.
The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

2021-12-09- JO-  the EN was submitted to FV wiith the link to the legislation (90/385/EEC, 93/42/EEC)
however since these legilsations have been repealed, the link has been removed and the EN is to proceed to publication

IEC Corrected version