11 - HEALTH CARE TECHNOLOGY
ICS 11 Details
HEALTH CARE TECHNOLOGY
MEDIZINTECHNIK
TECHNOLOGIES DE LA SANTE
ZDRAVSTVENO VARSTVO
General Information
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This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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.
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.
NOTE 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
– ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12.
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
– ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.
- Standard89 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the competencies required of assistance dogs’ professionals. The purpose of this document is to improve and ensure the quality of professionals working in a role within an assistance dog organization. Each speciality of assistance dog requires a specific set of role competencies and there are some common core competencies.
Core competencies in:
- breeding;
- puppy raising;
- dog care;
- assessors;
- orientation and mobility;
- trainers;
- instructors.
Specific competencies to train:
- guide dogs;
- hearing dogs;
- medical alert dogs;
- mobility assistance dogs;
- autism and development disorder dogs;
- team training instructor.
It is accepted that assistance dog organisations vary greatly in structure and not every organization will have all the roles identified. Where one person performs more than one role, it is expected that they will have the competencies of all the roles they perform e.g. a dog trainer may also have the competencies of a dog care specialist. And there will be some organisations where some of these roles are not required, e.g. those with no breeding programme will not require the associated role competencies.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
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”.
- Standard51 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a test method and the minimum requirements for mycobactericidal 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 - with water.
Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
This document is applicable to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying or flooding or other means and teat disinfection in the veterinary area - i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE This method corresponds to a phase 2 step 1 test.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
The test methods described are designed to determine the disinfectant activity of processes used in the 1) medical area, 2) veterinary area, 3) food, industrial, domestic and institutional area using automated processes for distributing chemicals by air diffusion with no operator manually applying the disinfectant. This document covers the disinfection of nonporous surfaces but not that of the air.
The objective of the described processes is to disinfect the surfaces of the overall area including the external surfaces of the equipment contained in such rooms. Air handling and products or processes specifically designed for the disinfection of medical devices are excluded from the scope of this document. The test methods and volumes described provide a defined challenge.
This document is applicable to processes for which activity is claimed against the following groups of microorganisms:
— vegetative bacteria,
— mycobacteria,
— bacterial spores,
— yeasts,
— fungal spores,
— viruses,
— bacteriophages.
This document does not cover processes for which the mode of action is based on immersing and/or circulation, flooding, spraying, wiping or other processes where the product is directly applied to the surfaces and not via air dispersion.
- Standard64 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Draft24 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
NOTE This document has been prepared to address the relevant essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.
- Draft43 pagesEnglish languagesale 10% offe-Library read for1 day
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.
- Draft29 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 62083:2025, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system.
This document applies to the communication of the radiotherapy treatment planning system with other devices
– used in medical practice,
– that imports data either through input by the operator or from other devices,
– that outputs data to other devices, and
– that is intended to be
- for normal use, under the authority of appropriately qualified persons, by operators having the required skills and training,
- used and maintained in accordance with the recommendations given in the instructions for use, and
– used within the environmental conditions specified in the technical description.
This document applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system.
IEC 62083:2025 cancels and replaces the second edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
– modification of the title from Medical electrical system - Requirements for the safety of radiotherapy treatment planning systems, to Medical device software - Requirements for the safety of radiotherapy treatment planning systems;
– Adaptive radiotherapy is added with Clause 16;
– The title reflects different implementations of radiotherapy treatment planning systems.
- Standard57 pagesEnglish languagesale 15% off
- Standard63 pagesFrench languagesale 15% off
- Standard120 pagesEnglish and French languagesale 15% off
IEC 61267:2025 applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment, require well-defined X-ray radiation conditions. This document deals with methods for generating X-ray radiation conditions which can be used under test conditions typically found in test laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-ray equipment.
IEC 61267:2025 cancels and replaces the second edition published 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) removing former Annex C “Measurement of the practical peak voltage”;
b) inserting informative “Tabulated values for the squared signal-to-noise ratio per air kerma (SNR2in)” and normative “Additional X-ray radiation conditions as used in mammography and determination of the corresponding nominal aluminium half-value layers”;
c) revision of X-ray radiation conditions;
d) new method for verification of X-ray radiation conditions;
e) change of term definitions.
- Standard44 pagesEnglish languagesale 15% off
- Standard47 pagesFrench languagesale 15% off
- Standard91 pagesEnglish and French languagesale 15% off
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201). This document applies to both electrical and non-electrical(manual) MEDICAL BEDS with or without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm. If a MANUFACTURER wishes to make a bed that can be used by both a CHILD and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply. This document does not apply to: • ADULT only beds covered by IEC 80601-2-52; • SPECIALITY MATTRESS covered by the ISO 20342 series; • incubators covered by IEC 60601-2-19; • devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table). If a clause or subclause is specifically intended to be applicable to a MEDICAL BED 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 MEDICAL BEDS and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1.
- Standard214 pagesEnglish and French languagesale 15% off
- Draft100 pagesEnglish languagesale 15% off
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”.
- Standard49 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE Requirements that are common to both portable units and base units are specified in ISO 18777-1.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-64:2025 applies to the BASIC SAFETY and essential performance of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of patients. 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.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacturer and specified installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-64:2025 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) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020;
b) harmonization with IEC 62667:2017 for defined terms and definitions;
c) address revision to neutrons outside the field of irradiation.
- Standard185 pagesEnglish languagesale 15% off
IEC 80601-2-89:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).
This document applies to both electrical and non-electrical(manual) MEDICAL BEDS with or without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm.
If a MANUFACTURER wishes to make a bed that can be used by both a CHILD and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply.
This document does not apply to:
• ADULT only beds covered by IEC 80601-2-52;
• SPECIALITY MATTRESS covered by the ISO 20342 series;
• incubators covered by IEC 60601-2-19;
• devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table).
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED 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 MEDICAL BEDS and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1.
- Standard105 pagesEnglish languagesale 15% off
- Standard109 pagesFrench languagesale 15% off
- Standard214 pagesEnglish and French languagesale 15% off
IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.
MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the competencies required of assistance dogs’ professionals. The purpose of this document is to improve and ensure the quality of professionals working in a role within an assistance dog organization. Each speciality of assistance dog requires a specific set of role competencies and there are some common core competencies.
Core competencies in:
- breeding;
- puppy raising;
- dog care;
- assessors;
- orientation and mobility;
- trainers;
- instructors.
Specific competencies to train:
- guide dogs;
- hearing dogs;
- medical alert dogs;
- mobility assistance dogs;
- autism and development disorder dogs;
- team training instructor.
It is accepted that assistance dog organisations vary greatly in structure and not every organization will have all the roles identified. Where one person performs more than one role, it is expected that they will have the competencies of all the roles they perform e.g. a dog trainer may also have the competencies of a dog care specialist. And there will be some organisations where some of these roles are not required, e.g. those with no breeding programme will not require the associated role competencies.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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.
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.
NOTE 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
– ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12.
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
– ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.
- Standard89 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment. This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling. MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear). This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient. The requirements in this document take priority over the requirements in ISO 18190. This document does not cover oral appliances. NOTE This document has been prepared to address the relevant essential principles[14] and labelling principles[15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.
- Standard36 pagesEnglish languagesale 15% off
- Standard37 pagesFrench languagesale 15% off
This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE Requirements that are common to both portable units and base units are specified in ISO 18777-1.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
NOTE This document has been prepared to address the relevant essential principles [14] and labelling principles [15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.
- Standard36 pagesEnglish languagesale 15% off
- Standard37 pagesFrench languagesale 15% off
- Amendment38 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
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This document specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. This document also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. The described method is intended to be used to measure the amount of deformation under load and plastic deformation after unloading of various designs and materials used for acetabular components in total hip joint replacement. These measurements are then used in an evaluation of risks associated with acetabular cup deformation for the acetabular component under evaluation to determine if its performance can be adversely affected. In the evaluation of risks associated with acetabular component deformation, it can be useful to take into consideration various design, material and surgical implantation factors (e.g. those identified in REF Section_sec_8 \r \h Clause 8 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0038000000 ), and, if necessary, a comparison of results to a reference implant tested under the same conditions. Depending on this evaluation, either additional testing or clinical data, or both, which is outside the scope of this document, can be necessary. The loading of the acetabular components in vivo differs, in general, from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. This document does not cover methods that examine the test specimens.
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This document specifies a test procedure to simulate and to evaluate lumbar and cervical spinal disc prostheses wear under adverse impingement conditions.
- Standard15 pagesEnglish languagesale 15% off
ISO 80601-2-70:2025 This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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.
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.
NOTE 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
– ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12.
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
– ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.
- Standard78 pagesEnglish languagesale 15% off
- Standard83 pagesFrench languagesale 15% off
This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. 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. 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. NOTE 2 See also 4.2 of the general standard. This document does not specify the requirements for: – ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. – ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. – ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. – ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84. – ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80. – high-frequency ventilators[23], which are given in ISO 80601-2-87. – respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. – user-powered resuscitators, which are given in ISO 10651-4; – gas-powered emergency resuscitators, which are given in ISO 10651-5; – oxygen therapy constant flow ME equipment; and – cuirass or “iron-lung” ventilation equipment.
- Standard78 pagesEnglish languagesale 15% off
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This document provides a method for quantification of marker peptide of type I collagen which was purified products extracted from bovine tissues with liquid chromatography - tandem mass spectrometry (LC-MS/MS). The method described in this document is intended to be used for marker peptide detection of purified bovine type I collagen which will be used for constructing tissue-engineered medical products (TEMPs) or other collagen-based biomaterials, for product quality control. This method also can be used for qualitative analysis and quantitative detection of bovine-specific and/or type I-specific collagen in the samples mixed with other animal sources and/or other type collagen. This document does not exclude other possible methods for quantifying type I collagen, such as hydroxyproline quantification, that can evaluate the total amount of collagen regardless of type. NOTE 1 The collagen has been known there are greater than 28 types and with the different property in each one. This document focuses on the quantification of marker peptide of purified bovine type I collagen. Type I collagen isolated from skin, tendon, bone, etc., can contain other types of collagen, for example, type III and type V. And type I collagen can be sourced from bovine, swine, etc. For quantification of other types of collagens or type I collagen sourced from other species of animals can use this document as a template, but need to design collagen type-specific or/and animal species-specific characteristic peptides for LC-MS/MS method, as well as optimize the determination conditions. NOTE 2 For quantification of the collagen marker peptide of scaffold which combined with other materials, or type I collagen contained in ECM materials of tissues or type I collagen-based regenerative tissues, can refer to this document, but need to isolate or/and purify the type I collagen with a reasonable and verified method at first (9,10), and then quantify it by referring to the method provided in this document.
- Standard10 pagesEnglish languagesale 15% off
The test methods described are designed to determine the disinfectant activity of processes used in the 1) medical area, 2) veterinary area, 3) food, industrial, domestic and institutional area using automated processes for distributing chemicals by air diffusion with no operator manually applying the disinfectant. This document covers the disinfection of nonporous surfaces but not that of the air.
The objective of the described processes is to disinfect the surfaces of the overall area including the external surfaces of the equipment contained in such rooms. Air handling and products or processes specifically designed for the disinfection of medical devices are excluded from the scope of this document. The test methods and volumes described provide a defined challenge.
This document is applicable to processes for which activity is claimed against the following groups of microorganisms:
— vegetative bacteria,
— mycobacteria,
— bacterial spores,
— yeasts,
— fungal spores,
— viruses,
— bacteriophages.
This document does not cover processes for which the mode of action is based on immersing and/or circulation, flooding, spraying, wiping or other processes where the product is directly applied to the surfaces and not via air dispersion.
- Standard64 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971. This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either: — a patient's body during intended use or reasonably foreseeable misuse; or — the body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks). Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with: — constituents of a medical device; and — tissue-device interactions (including physical effects). The biological evaluation specified in this document can address the biological safety of the medical device, considering the life cycle from design and development through initial use of the finished medical device to final decommissioning or withdrawal from use. The biological evaluation considers both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle. However, the evaluation of risks related to environmental impacts of decommissioning of medical devices are not within the scope of this document. This document does not mandate re-testing of medical devices that are already on the market and have established and acceptable safety profiles (see REF Section_sec_6.6.2 \r \h 6.6.2 08D0C9EA79F9BACE118C8200AA004BA90B020000000800000012000000530065006300740069006F006E005F007300650063005F0036002E0036002E0032000000 ). This document can be useful to support clinical or usability evaluations of medical devices. For example, a biological evaluation is a pre-requisite for conducting a clinical trial. This means that principles outlined in this document can be applied to the evaluation of prototype or development stage devices, as well as to finished medical devices. Other parts of the ISO 10993 series cover specific aspects of biological evaluation, such as chemical characterization, biological testing, sample preparation, animal welfare and toxicological risk assessment. For some types of medical devices, specific requirements from other standards (outside the ISO 10993 series) can be considered with a justification for the approach taken if there are differences between the requirements of the ISO 10993 series and those provided in other standards. For example, the ISO 18562 series provides specific requirements for biological evaluation of breathing gas pathway medical devices and ISO 7405 provides specific requirements for biological evaluation of dental devices. The evaluation of risks related to infectious agents [e.g. bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents] is not within the scope of this document. NOTE 1 The evaluation of bacterial endotoxins is addressed by ISO 11737-3. NOTE 2 The evaluation of risks related to viruses, TSE agents and other pathogens originating from materials of animal origin is addressed by the ISO 22442 series.
- Standard42 pagesEnglish languagesale 15% off
- Draft52 pagesFrench languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.
- Standard85 pagesEnglish languagesale 10% offe-Library read for1 day
The particular requirements of this part of IEC 60364 apply to electrical installations in
medical locations so as to provide safety of patients and medical staff. These requirements
refer to:
- hospitals and clinics or equivalent institutions (including equivalent transportable and
mobile locations);
which, subject to assessment (710.30), can also include:
- sanatoriums and health clinics;
- dedicated locations in homes for senior citizens and aged care homes, where patients
receive medical care;
- medical centres, outpatients' clinics and departments, casualty wards;
- other outpatients' institutions (industrial, sports and others);
- medical and dental practices;
- dedicated medical rooms in the workplace;
- other locations where medical electrical equipment is used;
- veterinary clinics;
- rooms in existing installations where a change of utilization for medical applications occur.
This list is not exhaustive.
The requirements of this document do not apply to ME equipment or ME systems.
NOTE 1 Medical ME equipment and ME systems are covered by IEC 60601 (all parts).
NOTE 2 In the USA, the requirements of NFPA 70®, National Electrical Code® in general and specifically article
517 (Healthcare Facilities) apply.
- Standardization document41 pagesEnglish languagesale 10% offe-Library read for1 day
This prAA represents common modifications to prHD 60364-7-710
2019-11-29: no xml because common mod
- Amendment21 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment. Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector. NOTE Requirements that are common to both portable units and base units are specified in ISO 18777-1.
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesFrench languagesale 15% off
This document addresses the specification and demonstration of capability and system reliability to successfully deliver a medicinal product as part of design verification and manufacture, utilizing empirical methods as well as modelling. This includes risk-based techniques to establish and demonstrate the required reliability level for all disposable single use drug delivery systems (DDSs) for which there is a single opportunity to deliver a single dose of a medicinal product. DDSs covered by this document include, but are not limited to: — needle-based injection systems (ISO 11608-1); — needle-free injection systems (ISO 21649); — aerosol drug delivery systems (ISO 20072). This document does not cover: — DDSs with containers that can be replaced; — DDSs intended for dental use; — finished needles; — empty syringes; — catheters; — DDSs for multi-patient use; — pumps [IEC 60601-2-24 (if electronic) or ISO 28620 (if non-electronic)]; — stand-alone prefilled syringes defined by ISO 11040-8. In this document system reliability is limited to assessing functional performance of the DDS and does not address human factors or user interface considerations. These will be covered by a usability engineering program in accordance with IEC 62366-1. NOTE DDSs not in scope of this document can still benefit from elements in this document but provisions of this document might not completely fulfil the basic safety and effectiveness of such DDSs.
- Technical specification15 pagesEnglish languagesale 15% off
This document extends the base nomenclature provided in ISO/IEEE 11073-10101:2020 to support terminology for implantable cardiac devices. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. This nomenclature defines the terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation. The nomenclature extensions may be used in conjunction with other IEEE 11073 standard components (e.g., ISO/IEEE 11073-10201 [B2] ) or with other standards, such as Health Level Seven International (HL7).
- Standard145 pagesEnglish languagesale 10% offe-Library read for1 day
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between independent living activity hubs and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards, including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined, for example, to determine when a person’s activities/behaviors have deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting).
- Standard46 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
- Standard29 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment38 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a common data exchange format (i.e. format of the messages and the dictionary of all the items that compose the message) between the prescribers and the laboratories in the animal health sector.
This document is intended for prescribers (purchasers) and service providers in charge of collecting samples and conducting analyses (including laboratories) who are interested in computerizing and standardizing their data exchanges, particularly in the animal health sector.
This document excludes the code lists that are required for unambiguous data exchange.
- Standard53 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.
- Standard7 pagesEnglish languagesale 15% off
This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry. This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2). The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy. This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made. NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
- Standard20 pagesEnglish languagesale 15% off
- Standard20 pagesFrench languagesale 15% off
This document specifies contact tracing procedures for highly contagious respiratory infectious disease cases, including both symptomatic and asymptomatic infections for pandemic response. This document provides: — an overview and general procedures of contact tracing; — requirements and privacy protection guidance in contact tracing.
- Standard18 pagesEnglish languagesale 15% off
This document specifies a common data exchange format (i.e. format of the messages and the dictionary of all the items that compose the message) between the prescribers and the laboratories in the animal health sector.
This document is intended for prescribers (purchasers) and service providers in charge of collecting samples and conducting analyses (including laboratories) who are interested in computerizing and standardizing their data exchanges, particularly in the animal health sector.
This document excludes the code lists that are required for unambiguous data exchange.
- Standard53 pagesEnglish languagesale 10% offe-Library read for1 day