2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water – or in the case of ready-to-use products, i.e. products that are not diluted when applied, – with water. Ready-to-use-products can only be tested at a concentration up to 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
This document is applicable to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This document is applicable 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 can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2, step 1 test.
NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures. It ensures compatibility with containers for blood and blood components as well as intravenous equipment.
This document also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components.
NOTE            In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

This document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular and plasma blood components.
NOTE            In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

TThis document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water - or in the case of ready-to-use products, i.e, products that are not diluted when applied, - with water. Ready-to-use-products can only be tested at a concentration up to 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
This document applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
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 can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.
NOTE 1   The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2   This method corresponds to a phase 2, step 1 test.
NOTE 3   EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.

This document specifies requirements for electrically heated steam boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only steam boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar ∙ l.

This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances.
The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use.
The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal requirement or the manufacturers’ decision.
This document does not cover
—     devices for medication loading and transfer, utilizing a blunt tip design, or
—     invasive products whose intended use is to access small spaces, particularly ear, nose and throat, to perform ophthalmic procedures
because their SIPMs have been found to adversely affect the usability and can increase the risk for patients versus the benefit of the intended use of the device.
This document does not cover solid-core needles used for surgery (e.g. suture needles).

This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially Type IV allergenic substances employed and remaining in medical gloves. It also provides information on the extraction medium, the method of extraction and quantitative assay of residual chemicals.
This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.

This document specifies specific requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and information supplied by the manufacturer.

This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer.
This document is applicable to:
—     all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames;
—     spectacle frames made with additive manufacturing, for example, 3D printing;
—     spectacle frames made from natural organic materials;
—     the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply;
—     prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask.
Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1.
NOTE            See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames.
This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.

This document specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This document applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This document does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE   Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665.
This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

This document specifies requirements for electrically heated steam boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only steam boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar ∙ l.

This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer.
This document is applicable to:
—     all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames;
—     spectacle frames made with additive manufacturing, for example, 3D printing;
—     spectacle frames made from natural organic materials;
—     the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply;
—     prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask.
Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1.
NOTE            See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames.
This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.

This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially Type IV allergenic substances employed and remaining in medical gloves. It also provides information on the extraction medium, the method of extraction and quantitative assay of residual chemicals.
This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.

This document specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This document applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This document does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE   Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665.
This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

This document specifies specific requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and information supplied by the manufacturer.

This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances.
The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use.
The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal requirement or the manufacturers’ decision.
This document does not cover
—     devices for medication loading and transfer, utilizing a blunt tip design, or
—     invasive products whose intended use is to access small spaces, particularly ear, nose and throat, to perform ophthalmic procedures
because their SIPMs have been found to adversely affect the usability and can increase the risk for patients versus the benefit of the intended use of the device.
This document does not cover solid-core needles used for surgery (e.g. suture needles).

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.

This document specifies polymers commonly used in manufacturing dental instruments.
It is applicable to polymers used to manufacture either an entire instrument or part of an instrument.
It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not.
This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers.
This document contains a selection of polymers suitable for use in the manufacture of dental instruments.

This document specifies polymers commonly used in manufacturing dental instruments.
It is applicable to polymers used to manufacture either an entire instrument or part of an instrument.
It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not.
This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers.
This document contains a selection of polymers suitable for use in the manufacture of dental instruments.

This document specifies fundamental requirements for uncut finished spectacle lenses. This document is not applicable to protective spectacle lenses.
This document takes precedence over the corresponding requirements of other standards, if differences exist.

2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes

This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off which is relevant to the verification of performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.
In addition, this document specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features (see NOTE), by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
These loading conditions are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.
The test loading conditions specified in this document are characterized by standardized formats of these loading and locomotion profiles, applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.
This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to the intended use. According to the concept of the tests of this document, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load.
This document is suitable for the assessment and testing of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2016, need not be retested to this document.
NOTE            The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4 (R4) specified in this document approach those determining the sagittal plane loading of the test loading conditions I and II for the principal structural tests referring to ISO 10328:2016, without changing the values of the angles of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328:2016.

2022-05-21-JO- to ensure continuity, HAS assessment should be prepared by Tony Wilkes

This document specifies fundamental requirements for uncut finished spectacle lenses. This document is not applicable to protective spectacle lenses.
This document takes precedence over the corresponding requirements of other standards, if differences exist.

This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off which is relevant to the verification of performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.
In addition, this document specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features (see NOTE), by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
These loading conditions are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.
The test loading conditions specified in this document are characterized by standardized formats of these loading and locomotion profiles, applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.
This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to the intended use. According to the concept of the tests of this document, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load.
This document is suitable for the assessment and testing of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2016, need not be retested to this document.
NOTE            The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4 (R4) specified in this document approach those determining the sagittal plane loading of the test loading conditions I and II for the principal structural tests referring to ISO 10328:2016, without changing the values of the angles of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328:2016.

This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as:
a)       bed frames;
b)       bedside tables;
c)        transport carts;
d)       containers;
e)       surgical tables;
f)         sterilization containers;
g)       surgical clogs;
h)       wheelchairs;
i)         aids for persons with disabilities.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs.
NOTE 1        WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2        The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.

IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be:
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 80601-2-68:2024 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with the new editions of the relevant standards:
– IEC 60601-2-1:2020;
– IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016;
– IEC 60601-2-64:2014;
b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE);
c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.

This document provides an opinion on the application of the classification rules in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as they pertain to dental devices and accessories.

This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as:
a)       bed frames;
b)       bedside tables;
c)        transport carts;
d)       containers;
e)       surgical tables;
f)         sterilization containers;
g)       surgical clogs;
h)       wheelchairs;
i)         aids for persons with disabilities.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs.
NOTE 1        WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2        The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.

IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT. This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be: • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and • subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. IEC 80601-2-68:2024 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with the new editions of the relevant standards: – IEC 60601-2-1:2020; – IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016; – IEC 60601-2-64:2014; b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE); c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.

This document provides an opinion on the application of the classification rules in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as they pertain to dental devices and accessories.

1.1   This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
1.2   This document specifies minimum requirements:
-   for the performance and design of sterilizers intended to deliver an LTSF process capable of sterilizing medical devices;
-   for the equipment and controls of these sterilizers which are needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process.
1.3   This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document.
1.4   This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1.
NOTE            The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

This document specifies general performance requirements for washer-disinfectors (WD) and washer-disinfector accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified.
NOTE 1        The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice.
The requirements for WD intended to process specific loads are specified in ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7. For WD intended to process loads of two or more different types, the requirements of the applicable parts of ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7 apply.
This document does not specify requirements intended for machines for use for laundry or general catering purposes.
This document does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers” and addressed in other standards.
The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 2        Chemicals in some cleaning agents and disinfectants can react with prion protein in a manner that can inhibit its removal or inactivation.  If the presence of prion protein is considered a possibility, then this can influence the choice of cleaning agent and disinfectant.
NOTE 3        This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed WD throughout its service life. Guidance on a routine test programme is given in Annex A.

1.1   This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
1.2   This document specifies minimum requirements:
-   for the performance and design of sterilizers intended to deliver an LTSF process capable of sterilizing medical devices;
-   for the equipment and controls of these sterilizers which are needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process.
1.3   This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document.
1.4   This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

This document specifies requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, washing and thermal disinfection of non-critical devices in the form of human waste containers by one operating cycle.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except for those specified in 4.1.1, and with the requirements of ISO 15883-5:2021, except for those specified in 4.1.2.

This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1.
NOTE            The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

This document specifies requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, washing and thermal disinfection of non-critical devices in the form of human waste containers by one operating cycle.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except for those specified in 4.1.1, and with the requirements of ISO 15883-5:2021, except for those specified in 4.1.2.

This document specifies general performance requirements for washer-disinfectors (WD) and washer-disinfector accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified.
NOTE 1        The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice.
The requirements for WD intended to process specific loads are specified in ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7. For WD intended to process loads of two or more different types, the requirements of the applicable parts of ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7 apply.
This document does not specify requirements intended for machines for use for laundry or general catering purposes.
This document does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers” and addressed in other standards.
The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 2        Chemicals in some cleaning agents and disinfectants can react with prion protein in a manner that can inhibit its removal or inactivation.  If the presence of prion protein is considered a possibility, then this can influence the choice of cleaning agent and disinfectant.
NOTE 3        This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed WD throughout its service life. Guidance on a routine test programme is given in Annex A.