Infoteenus
11 TERVISEHOOLDUS
Uued standardid
EVS-EN ISO 80369-1:2026
Meditsiinis kasutatavad väikseavalised liitmikud vedelikele ja gaasidele. Osa 1: Üldnõuded
Käsitlusala:
ISO 80369-1 specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. It also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
— respiratory,
— enteral,
— limb cuff inflation,
— neural,
— intravascular or hypodermic,
— other use cases utilising an ISO 80369-7 small-bore connector.
ISO 80369-1 provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this standard as well as those that can be developed under future parts of the ISO and IEC 80369 series.
ISO 80369-1:2025 text has been approved in Europe as EN ISO 80369-1:2026 without any changes.
Alusdokumendid: ISO 80369-1:2025; EN ISO 80369-1:2026
Asendab: EVS-EN ISO 80369-1:2018
EVS-EN ISO 12487:2026
Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO 12487:2026)
Käsitlusala: This document specifies the requirements and methods for the clinical investigation of medical electrical (ME) equipment used to measure the body temperature in indirect measurement mode.
This document covers both intermittently and continuously measuring clinical thermometers.
NOTE 1 This document does not apply to clinical thermometers measuring the body temperature in direct measurement mode.
NOTE 2 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with ISO 80601-2-56:—1) is considered sufficient.
This document is applicable to clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as predictive type thermometers and fall under the scope of this document.
This document specifies additional disclosure requirements.
This document does not apply to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution.
NOTE 3 ISO 80601-2-56:—1) does include pulmonary artery catheter for the determination of cardiac output by thermodilution.
This document covers both intermittently and continuously measuring clinical thermometers.
NOTE 1 This document does not apply to clinical thermometers measuring the body temperature in direct measurement mode.
NOTE 2 For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with ISO 80601-2-56:—1) is considered sufficient.
This document is applicable to clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as predictive type thermometers and fall under the scope of this document.
This document specifies additional disclosure requirements.
This document does not apply to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution.
NOTE 3 ISO 80601-2-56:—1) does include pulmonary artery catheter for the determination of cardiac output by thermodilution.
Alusdokumendid: ISO 12487:2026; EN ISO 12487:2026
EVS-EN 18167:2026
Quality along the patient pathway for medical imaging in radiology services
Käsitlusala: This document specifies the requirements for implementation of a quality system along the patient pathway in radiology services. The objective is to ensure high quality delivery of all aspects of the examination safety and patient care.
This document deals with procedures using X-rays, ultrasonography and magnetic resonance imaging on humans, including diagnostic procedures and interventional radiology as well as remote practices. It also applies, in its principles, to any other technique and modality that would be used in radiology services.
The document covers:
- the different steps of patient care (from the imaging referral, before, during, and after the examination);
- the corresponding human resources and technical-medical requirements;
- quality and risk management.
This document does not apply to radiotherapy and nuclear medicine, nor to equipment and radiation controls which are covered in other standards. This document excludes requirements related to research and education themes.
This document establishes best practices description which constitutes a reference for audits, including clinical audits. Nevertheless, the clinical audits methodology, already defined at the European level, and implemented under the responsibility of each country is excluded from the document.
This document deals with procedures using X-rays, ultrasonography and magnetic resonance imaging on humans, including diagnostic procedures and interventional radiology as well as remote practices. It also applies, in its principles, to any other technique and modality that would be used in radiology services.
The document covers:
- the different steps of patient care (from the imaging referral, before, during, and after the examination);
- the corresponding human resources and technical-medical requirements;
- quality and risk management.
This document does not apply to radiotherapy and nuclear medicine, nor to equipment and radiation controls which are covered in other standards. This document excludes requirements related to research and education themes.
This document establishes best practices description which constitutes a reference for audits, including clinical audits. Nevertheless, the clinical audits methodology, already defined at the European level, and implemented under the responsibility of each country is excluded from the document.
Alusdokumendid: EN 18167:2026
EVS-EN ISO 9680:2026
Dentistry - Operating lights (ISO 9680:2026)
Käsitlusala: This document specifies requirements and test methods for operating lights used in dental treatment and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources and those intended for patient contact, e.g. from dental handpieces and dental headlamps, fibreoptic intraoral operating lights and operating lights which are specifically designed for use in oral surgery.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources and those intended for patient contact, e.g. from dental handpieces and dental headlamps, fibreoptic intraoral operating lights and operating lights which are specifically designed for use in oral surgery.
Alusdokumendid: ISO 9680:2026; EN ISO 9680:2026
Asendab: EVS-EN ISO 9680:2021
EVS-EN ISO 5364:2026
Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2026)
Käsitlusala: This document specifies requirements for oropharyngeal airways.
This document is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
This document is not applicable to supralaryngeal airways, which are covered by ISO 11712[1].
The requirements that are also applicable to other airway devices have been removed from this document as they now appear in the general airway device standard (ISO 18190).
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190).
This document is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
This document is not applicable to supralaryngeal airways, which are covered by ISO 11712[1].
The requirements that are also applicable to other airway devices have been removed from this document as they now appear in the general airway device standard (ISO 18190).
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190).
Alusdokumendid: ISO 5364:2026; EN ISO 5364:2026
Asendab: EVS-EN ISO 5364:2016
ISO 3964-1:2026
Dentistry — Coupling dimensions for handpiece connectors — Part 1: Mechanical properties
Käsitlusala: This document specifies coupling between handpieces and motors that are connected to dental units. For the purposes of this document, the couplings described in this document are not equipped with electronic terminal(s).
This document specifies the nominal dimensions, tolerances and extraction force of coupling systems for use between handpieces and motor which supply the handpiece with water, air and light and rotation energy.
This document specifies the nominal dimensions, tolerances and extraction force of coupling systems for use between handpieces and motor which supply the handpiece with water, air and light and rotation energy.
Alusdokumendid:
ISO 3630-8:2026
Dentistry — Endodontic instruments — Part 8: Accuracy of electronic apex locator
Käsitlusala: This document specifies requirements and test methods for measuring the accuracy of electronic apex locators that are used to determine the apex location during endodontic treatment.
Alusdokumendid:
ISO 11040-8:2026
Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
Käsitlusala: This document is applicable to aseptically processed or terminally sterilized finished prefilled syringes (intended for single use only) based on syringe barrel components addressed in ISO 11040-4 or ISO 11040-6, together with a plunger stopper (sealing the back end) based on components addressed in ISO 11040-5 and a front end closure for parenteral preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.
Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent-containing syringes that have been emptied for reconstitution and in which the reconstituted injectable product has been aspirated after reconstitution) are excluded from the scope of this document.
NOTE 1 This document can also be used as a guidance for other types, designs and/or sizes of finished prefilled syringes, for example dual chamber prefilled syringes.
NOTE 2 For finished prefilled syringes that are used in needle-based injection systems, see also ISO 11608 (all parts).
NOTE 3 Attention is drawn to applicable national or regional regulations and pharmacopoeias, such as Ph.Eur. [2], USP [3] or JP [4].
NOTE 4 Finished prefilled syringes for parenteral preparations which are medical devices or which, according to the principal mode of action of the product (i.e. the means by which the product achieves its principal intended action), are borderline between medical devices and medicinal products fall within the scope of this document, even if they are not always regulated as medicinal products.
Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent-containing syringes that have been emptied for reconstitution and in which the reconstituted injectable product has been aspirated after reconstitution) are excluded from the scope of this document.
NOTE 1 This document can also be used as a guidance for other types, designs and/or sizes of finished prefilled syringes, for example dual chamber prefilled syringes.
NOTE 2 For finished prefilled syringes that are used in needle-based injection systems, see also ISO 11608 (all parts).
NOTE 3 Attention is drawn to applicable national or regional regulations and pharmacopoeias, such as Ph.Eur. [2], USP [3] or JP [4].
NOTE 4 Finished prefilled syringes for parenteral preparations which are medical devices or which, according to the principal mode of action of the product (i.e. the means by which the product achieves its principal intended action), are borderline between medical devices and medicinal products fall within the scope of this document, even if they are not always regulated as medicinal products.
Alusdokumendid:
Asendab: ISO 11040-8:2016
ISO 9680:2026
Dentistry — Operating lights
Käsitlusala: This document specifies requirements and test methods for operating lights used in dental treatment and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources and those intended for patient contact, e.g. from dental handpieces and dental headlamps, fibreoptic intraoral operating lights and operating lights which are specifically designed for use in oral surgery.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources and those intended for patient contact, e.g. from dental handpieces and dental headlamps, fibreoptic intraoral operating lights and operating lights which are specifically designed for use in oral surgery.
Alusdokumendid:
Asendab: ISO 9680:2021
Asendatud standardid
EVS-EN ISO 5364:2016
Anesteesia- ja hingamisaparatuur. Suu-kõrikaudsed õhutorud
Käsitlusala: ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.
ISO 5364:2016 is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units, or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard.
ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.
ISO 5364:2016 is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units, or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard.
ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.
Alusdokumendid: ISO 5364:2016; EN ISO 5364:2016
Asendatud: EVS-EN ISO 5364:2026
EVS-EN ISO 80369-1:2018
Meditsiinis kasutatavad väikseavalised liitmikud vedelikele ja gaasidele. Osa 1: Üldnõuded
Käsitlusala: This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.
This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields include, but are not limited to:
— breathing systems and driving gases;
— enteral;
— limb cuff inflation;
— neuraxial;
— intravascular or hypodermic.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered.
NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur.
NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.
This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields include, but are not limited to:
— breathing systems and driving gases;
— enteral;
— limb cuff inflation;
— neuraxial;
— intravascular or hypodermic.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered.
NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur.
NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.
Alusdokumendid: ISO 80369-1:2018; EN ISO 80369-1:2018
Asendatud: EVS-EN ISO 80369-1:2026
ISO 3964:2016
Dentistry -- Coupling dimensions for handpiece connectors
Käsitlusala: ISO 3964:2016 specifies the coupling between handpieces and motors connected to dental units.
ISO 3964:2016 specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motor which supply the handpiece with water, air and light and rotation energy.
ISO 3964:2016 specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motor which supply the handpiece with water, air and light and rotation energy.
Alusdokumendid:
Asendatud: ISO 3964-1:2026
ISO 11040-8:2016
Prefilled syringes -- Part 8: Requirements and test methods for finished prefilled syringes
Käsitlusala: ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040-4 or ISO 11040-6, together with ISO 11040-5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.
Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of ISO 11040-8:2016.
Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of ISO 11040-8:2016.
Alusdokumendid:
Asendatud: ISO 11040-8:2026
ISO 3964:2016/Amd 1:2018
ISO 3964:2016 - Amendment
Käsitlusala: Amendment to ISO 3964:2016
Alusdokumendid:
Asendatud: ISO 3964-1:2026
ISO 9680:2021
Dentistry — Operating lights
Käsitlusala: This document specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.
Alusdokumendid:
Asendatud: ISO 9680:2026
EVS-EN ISO 9680:2021
Dentistry - Operating lights (ISO 9680:2021)
Käsitlusala: This document specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.
Alusdokumendid: ISO 9680:2021; EN ISO 9680:2021
Asendatud: EVS-EN ISO 9680:2026
Kavandid
prEN 1865-1
Patient handling equipment used in ambulances - Part 1: Specification for general stretcher systems and patient handling equipment
Käsitlusala: This document specifies minimum requirements for the design and performance of stretchers and other patient handling equipment used in road ambulances for the handling and carrying of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.
Alusdokumendid: prEN 1865-1
prEN ISO 7551
Dentistry - Endodontic absorbent points (ISO/DIS 7551:2026)
Käsitlusala: This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.
Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.
Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.
Alusdokumendid: ISO/DIS 7551; prEN ISO 7551
prEN 1865-3
Patient handling equipment used in ambulances - Part 3: Heavy duty stretcher
Käsitlusala: This document specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.
Alusdokumendid: prEN 1865-3
prEN 1865-4
Patient handling equipment used in ambulances - Part 4: Foldable patient transfer chair
Käsitlusala: This document specifies minimum requirements for the design and performance of foldable patient transfer chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment.
Alusdokumendid: prEN 1865-4
prEN ISO 7198
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO/DIS 7198:2026)
Käsitlusala: ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to ISO 7198:2016. It can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.
NOTE Due to the variations in the design of implants covered by ISO 7198 :2016 and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 7198 :2016 will be necessary.
It is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.
Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of ISO 7198:2016.
While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, ISO 7198:2016 does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources.
Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of ISO 7198:2016.
Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of ISO 7198:2016. It includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539‑1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts).
NOTE Requirements for endovascular prostheses are specified in ISO 25539‑1.
The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of ISO 7198:2016. It can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices.
Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of ISO 7198:2016.
NOTE Requirements for vascular stents are specified in ISO 25539‑2.
Requirements regarding cell seeding are excluded from the scope of ISO 7198:2016. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in ISO 7198:201
NOTE Due to the variations in the design of implants covered by ISO 7198 :2016 and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 7198 :2016 will be necessary.
It is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.
Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of ISO 7198:2016.
While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, ISO 7198:2016 does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources.
Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of ISO 7198:2016.
Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of ISO 7198:2016. It includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539‑1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts).
NOTE Requirements for endovascular prostheses are specified in ISO 25539‑1.
The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of ISO 7198:2016. It can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices.
Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of ISO 7198:2016.
NOTE Requirements for vascular stents are specified in ISO 25539‑2.
Requirements regarding cell seeding are excluded from the scope of ISO 7198:2016. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in ISO 7198:201
Alusdokumendid: ISO/DIS 7198; prEN ISO 7198
prEN IEC 60601-2-18:2026
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Käsitlusala: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ENDOSCOPIC EQUIPMENT together with its INTERCONNECTION CONDITIONS and INTERFACE CONDITIONS.
Alusdokumendid: 62D/2302/CDV; prEN IEC 60601-2-18:2026
prEN IEC 80601-2-77:2026
Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
Käsitlusala: This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS. If a clause or subclause is specifically intended to be applicable to ME 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 ME EQUIPMENT and to ME SYSTEMS, as relevant.
If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the particular standard applies in addition to this standard.
EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT; IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for operating tables, etc.
Note: ME EQUIPMENT can be used with RASS for intraoperative surgical planning and visualization.
ME EQUIPMENT and ME SYSTEMS intended to be used for radiotherapy, nuclear medicine and radiation dosimetry (example: IEC 60601-2-68[8]) are excluded from the scope of this document.
If RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the particular standard applies in addition to this standard.
EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC EQUIPMENT; IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 60601-2-46[7] for operating tables, etc.
Note: ME EQUIPMENT can be used with RASS for intraoperative surgical planning and visualization.
ME EQUIPMENT and ME SYSTEMS intended to be used for radiotherapy, nuclear medicine and radiation dosimetry (example: IEC 60601-2-68[8]) are excluded from the scope of this document.
Alusdokumendid: 62D/2299/CDV; prEN IEC 80601-2-77:2026
prEN IEC 80601-2-78:2026
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Käsitlusala: This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of medical robots that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
Note: A MOVEMENT FUNCTION is a function consisting of one or more of sensory, neuromusculoskeletal or movement-related body functions that comprise PATIENT motor control.
A RACA ROBOT is defined in this standard as a PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS) with a LEVEL OF AUTONOMY greater than zero, comprising an ACTUATED APPLIED PART, intended by its MANUFACTURER to perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION
Note 1: a LEVEL OF AUTONOMY of zero is defined as having no AUTONOMY in any of its functions
RACA ROBOTS covered by this particular standard include but are not limited to:
• Exoskeletons or robotic orthoses for upper and lower limbs for ASSESSMENT, REHABILITATION, ALLEVIATION or COMPENSATION
• Robotic end-effectors for upper / lower extremities for ASSESSMENT or REHABILITATION
• Active balance control equipment for ASSESSMENT or REHABILITATION
• Overhead robotic body weight support systems
• Robotic walkers
• Robots intended to alleviate hemiplegic shoulder/ joint pain or spasticity through movement
• Continuous Passive Motion devices with a LEVEL OF AUTONOMY
Note 2: Annex AA lists examples of RACA ROBOT.
Note 3: This particular standard is primarily focused on human beings but, may also be used for animal PATIENTS.
The RISK MANAGEMENT PROCESS may be necessary to address specific BASIC SAFETY and ESSENTIAL PERFORMANCE for animal PATIENTS.
This particular standard does not apply to:
• Devices that support activities of daily living (including active assisted living), but do not directly address PATIENT MOVEMENT FUNCTIONS, such as:
o electric wheelchairs (use ISO 7176 (all parts)),
o personal care / service robots (use ISO 13482: 2014), e.g. feeding robots, robotic hoists, robotic bed
• Devices with a LEVEL OF AUTONOMY of zero
o E.g. Continuous Passive Motion devices with no AUTONOMY
• the following devices which are covered by other standards:
o external limb prosthetic devices (use ISO 22523: 2006),
o diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33: 2022),
____________
1 The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
o stationary training equipment (ISO 20957 series) e.g. treadmills
If a clause or subclause is specifically intended to be applicable to ME 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 ME EQUIPMENT and to ME SYSTEMS, as relevant.
NOTE See also 4.2 of the general standard.
Note: A MOVEMENT FUNCTION is a function consisting of one or more of sensory, neuromusculoskeletal or movement-related body functions that comprise PATIENT motor control.
A RACA ROBOT is defined in this standard as a PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS) with a LEVEL OF AUTONOMY greater than zero, comprising an ACTUATED APPLIED PART, intended by its MANUFACTURER to perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION
Note 1: a LEVEL OF AUTONOMY of zero is defined as having no AUTONOMY in any of its functions
RACA ROBOTS covered by this particular standard include but are not limited to:
• Exoskeletons or robotic orthoses for upper and lower limbs for ASSESSMENT, REHABILITATION, ALLEVIATION or COMPENSATION
• Robotic end-effectors for upper / lower extremities for ASSESSMENT or REHABILITATION
• Active balance control equipment for ASSESSMENT or REHABILITATION
• Overhead robotic body weight support systems
• Robotic walkers
• Robots intended to alleviate hemiplegic shoulder/ joint pain or spasticity through movement
• Continuous Passive Motion devices with a LEVEL OF AUTONOMY
Note 2: Annex AA lists examples of RACA ROBOT.
Note 3: This particular standard is primarily focused on human beings but, may also be used for animal PATIENTS.
The RISK MANAGEMENT PROCESS may be necessary to address specific BASIC SAFETY and ESSENTIAL PERFORMANCE for animal PATIENTS.
This particular standard does not apply to:
• Devices that support activities of daily living (including active assisted living), but do not directly address PATIENT MOVEMENT FUNCTIONS, such as:
o electric wheelchairs (use ISO 7176 (all parts)),
o personal care / service robots (use ISO 13482: 2014), e.g. feeding robots, robotic hoists, robotic bed
• Devices with a LEVEL OF AUTONOMY of zero
o E.g. Continuous Passive Motion devices with no AUTONOMY
• the following devices which are covered by other standards:
o external limb prosthetic devices (use ISO 22523: 2006),
o diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33: 2022),
____________
1 The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
o stationary training equipment (ISO 20957 series) e.g. treadmills
If a clause or subclause is specifically intended to be applicable to ME 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 ME EQUIPMENT and to ME SYSTEMS, as relevant.
NOTE See also 4.2 of the general standard.
Alusdokumendid: 62D/2304/CDV; prEN IEC 80601-2-78:2026