This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
.

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This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
.

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This document defines terms for abdominal diagnosis. The equivalent terms in Chinese characters (Pinyin), Japanese characters and Korean characters are given in Annex A.

  • Technical specification
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This International Standard defines terms in the field of sterilization of healthcare products used in the standards developed by ISO/TC 198 "Sterilization of healthcare products", CEN/TC 204 "Sterilization of medical devices", and CEN/TC 102 "Sterilizers and associated equipment for processing of medical devices".

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This document defines terms used to describe external limb prostheses. The terms related to the amputation level used to in this document are described in ISO 8549‑4. The types of component used in the construction of prostheses are classified and described in ISO 13405‑1, ISO 13405‑2 and ISO 13405‑3. For the purposes of this document, the abbreviated term ‘prosthetics’ and its derivatives only apply to external limb prosthetics.

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This document describes common terms related to forces and their effects as experienced by human bodies and their support surfaces. It provides further information on concepts around how these forces affect the human body's response to postural support systems, and particularly highlights the impact of the interface between tissues and postural support devices (PSD) on the maintenance of tissue integrity. It provides a general introduction to biomechanical concepts, phenomena, and vocabulary. This is intended to facilitate effective understanding and sharing of information between a range of disciplines/stakeholders involved in providing equipment to manage tissue integrity. Representative stakeholders include people with a disability, occupational therapists, physical therapists, biomedical engineers, nurses, medical and para medical personnel, device manufacturers, and other professionals facilitating development, provision, and access to seating and mobility equipment. This document does not provide detailed information that is currently available in physiological text books or scientific literature.

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This document specifies a classification and terminology of assistive products, especially produced or generally available, for persons to optimize functioning and reduce disability.
Assistive products used by a person to optimize functioning and reduce disability, but which require the assistance of another person for their operation, are included in the classification.
The following items are specifically excluded from this document:
—    items used for the installation of assistive products;
—    solutions obtained by combinations of assistive products that are individually classified in this document;
—    medicines;
—    assistive products and instruments used exclusively by healthcare professionals or by teachers;
—    non-technical solutions, such as personal assistance, guide dogs or lip-reading;
—    implanted devices;
—    financial support.

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This document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and supplies, related devices and supply systems.
NOTE 1    To avoid multiple definitions of the same term in different categories, this document attempts to ensure consistency by the inclusion of a ‘general’ category, and by use of domain specifiers and unique pre-coordinated domain-specific term names.
NOTE 2    In addition to terms and definitions used in two of the three official ISO languages (English and French), this document gives the equivalent terms in the German language; these are published under the responsibility of the member body for Germany. However, only the terms and definitions given in the official languages can be considered as ISO terms and definitions.

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This document specifies a classification and terminology of assistive products, especially produced or
generally available, for persons to optimize functioning and reduce disability.
Assistive products used by a person to optimize functioning and reduce disability, but which require
the assistance of another person for their operation, are included in the classification.
The following items are specifically excluded from this document:
— items used for the installation of assistive products;
— solutions obtained by combinations of assistive products that are individually classified in this
document;
— medicines;
— assistive products and instruments used exclusively by healthcare professionals or by teachers;
— non-technical solutions, such as personal assistance, guide dogs or lip-reading;
— implanted devices;
— financial support.

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IEC 60050-871:2018 gives the general terminology used in active assisted living, as well as general terms pertaining to specific applications and associated technologies. This terminology is consistent with the terminology developed in the other specialized parts of the IEV.
It has the status of a horizontal standard in accordance with IEC Guide 108.

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This document aims to specify a categorial structure in the field of disorder representation in traditional Chinese medicine (TCM) by defining a set of domain constraints for use within terminological resources. It contains a concept detailing the domains of four subcategories: body parts, causative agents, pathological process and manifestation. This document does not include: — a comprehensive categorial structure for TCM; — a treatment procedure for TCM; — relevant devices; — terms or descriptions for subcategories of body parts, causative agents, pathological process or manifestation.

  • Technical specification
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This document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and
supplies, related devices and supply systems.
NOTE 1 To avoid multiple definitions of the same term in different categories, this document attempts to
ensure consistency by the inclusion of a ‘general’ category, and by use of domain specifiers and unique precoordinated domain-specific term names.
NOTE 2 In addition to terms and definitions used in two of the three official ISO languages (English and
French), this document gives the equivalent terms in the German language; these are published under the
responsibility of the member body for Germany. However, only the terms and definitions given in the official
languages can be considered as ISO terms and definitions.

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This document provides recommended and other product type names and example pictures of product categories defined in ISO 9999, subclass 09 30, "Absorbing products to contain urine and faeces".

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This document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and supplies, related devices and supply systems. NOTE 1 To avoid multiple definitions of the same term in different categories, this document attempts to ensure consistency by the inclusion of a ‘general’ category, and by use of domain specifiers and unique pre-coordinated domain-specific term names. NOTE 2 In addition to terms and definitions used in two of the three official ISO languages (English and French), this document gives the equivalent terms in the German language; these are published under the responsibility of the member body for Germany. However, only the terms and definitions given in the official languages can be considered as ISO terms and definitions.

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  • Standard
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This document specifies the basic terminology of pulse diagnostic methods, the key elements of pulse and pulse condition. Each term of pulse diagnosis includes the English name, the classical Chinese characters and its definition.

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  • Standard
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This document specifies the basic terminology and classification of tongue diagnostic methods. Each term of tongue diagnosis includes the English name, the classical Chinese characters and its definition. The classification structure of tongue diagnosis terms is shown in Figure 1.

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  • Standard
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This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable
—     in lung ventilator and breathing-therapy device standards,
—     in health informatics standards,
—     for labelling on medical electrical equipment and medical electrical systems,
—     in medical electrical equipment and medical electrical system instructions for use and accompanying documents,
—     for medical electrical equipment and medical electrical systems interoperability, and
—     in electronic health records.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator and ventilator breathing system.
NOTE    This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.
This document does not specify terms specific to breathing-therapy equipment, or to physiologic closed-loop ventilation, high-frequency ventilation or negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.

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This document provides recommended and other product type names and example pictures of product
categories defined in ISO 9999, subclass 09 30, "Absorbing products to contain urine and faeces".

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This document provides recommended and other product type names and example pictures of product categories defined in ISO 9999, subclass 09 30, "Absorbing products to contain urine and faeces".

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  • Standard
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  • Standard
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This document defines terms used in dental product standards.
This document aims to facilitate the standard development process and the comprehension of standards, and to improve communication with the FDI World Dental Federation, the World Health Organization and other organizations interested in standardization.

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This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable
— in lung ventilator and breathing-therapy device standards,
— in health informatics standards,
— for labelling on medical electrical equipment and medical electrical systems,
— in medical electrical equipment and medical electrical system instructions for use and accompanying documents,
— for medical electrical equipment and medical electrical systems interoperability, and
— in electronic health records.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator and ventilator breathing system.
NOTE This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.
This document does not specify terms specific to breathing-therapy equipment, or to physiologic closed-loop ventilation, high-frequency ventilation or negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.

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This document specifies a measuring system for spectacle frames and related vocabulary. It is applicable to spectacle frames with fronts that are intended to be symmetrical.

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The purpose of this standard is to develop uniform nomenclature for the description of forensic dental data
and define a standardized set of uniform terms to convey this information. The goal of the standard is not to
define the extent of information collected, only to be certain that common terms are used in order to aid in an
identifying human remains or a living amnesiac.

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This document contains the terms, definitions, notes to entry and examples corresponding to the frequently used concepts which apply to diagnostic and therapeutic nuclear medicine. It comprises the minimum essential information for each nuclear medicine concept represented by a single term. It provides the reader with the information required to approach this multidisciplinary speciality, such as medical, radiopharmacy and medical physics point of view. It is intended to facilitate communication and promote common understanding.

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    18 pages
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  • Standard
    18 pages
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This document defines terms used in dental product standards.
This document aims to facilitate the standard development process and the comprehension of
standards, and to improve communication with the FDI World Dental Federation, the World Health
Organization and other organizations interested in standardization.

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This document defines terms used in dental product standards. This document aims to facilitate the standard development process and the comprehension of standards, and to improve communication with the FDI World Dental Federation, the World Health Organization and other organizations interested in standardization.

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This document defines terms relating to orthoses. This document does not include terms for orthoses that only encompass limb segments, as these orthoses are limited mainly to use in the treatment of fractures and in sports medicine. NOTE 1 The types of components used in the construction of orthoses are classified and described in ISO 13404. NOTE 2 For the purposes of this document the abbreviated term ?orthotics' and its derivatives only apply to external orthotics.

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This document defines general terms used to describe external limb prostheses and orthoses, and the personnel involved in the practice of prosthetics and orthotics. NOTE 1 The complete range of levels of limb amputation are listed and defined in ISO 8549-2. The complete range of classes of orthoses are listed and defined in ISO 8549-3. This document does not apply to breast, ocular or other external prostheses used to replace other parts of the human body, nor to dental prostheses or orthoses. NOTE 2 For the purposes of this document, the abbreviated term 'prosthetics' and its derivatives only apply to external limb prosthetics. The abbreviated term 'orthotics' and its derivatives only apply to external orthotics.

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  • Standard
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This document specifies a vocabulary for the description of surgical limb amputations, amputation procedures, and persons who have had an amputation.

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This document defines terms used in healthcare organization management.

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This document specifies a measuring system for spectacle frames and related vocabulary. It is applicable
to spectacle frames with fronts that are intended to be symmetrical.

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This document defines terms for the theory, technology and methods of Chinese Materia Medica processing. It is not applicable to Kampo medicine.

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  • Standard
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This document defines terms relating to ophthalmic optics, specifically to blanks, finished spectacle lenses and fitting purposes.
Terms relating to processes and material for fabrication and surface treatment (other than some specific terms relating to coatings), and terms relating to defects in materials and after optical processing are given in ISO 9802.

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This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable — in lung ventilator and breathing-therapy device standards, — in health informatics standards, — for labelling on medical electrical equipment and medical electrical systems, — in medical electrical equipment and medical electrical system instructions for use and accompanying documents, — for medical electrical equipment and medical electrical systems interoperability, and — in electronic health records. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator and ventilator breathing system. NOTE This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems. This document does not specify terms specific to breathing-therapy equipment, or to physiologic closed-loop ventilation, high-frequency ventilation or negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.

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  • Standard
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  • Standard
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This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them.
NOTE       Terms are listed in the alphabetical order of the English terms in the English version of this document.

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This document establishes the core classification framework for the integration of clinical terms from traditional Chinese medicine (TCM) and Western medicine. This structure supports terminology integration in standardized electronic medical records, including professional clinical terms in TCM and Western medicine. Non-technical terms for electronic medical records are also included.

  • Technical specification
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  • Technical specification
    8 pages
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This document defines terms relating to ophthalmic optics, specifically to blanks, finished spectacle
lenses and fitting purposes.
Terms relating to processes and material for fabrication and surface treatment (other than some specific
terms relating to coatings), and terms relating to defects in materials and after optical processing are
given in ISO 9802.

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This document defines terms in the field of the sterilization of health care products including related equipment and processes.

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This document defines terms relating to ophthalmic optics, specifically to blanks, finished spectacle lenses and fitting purposes. Terms relating to processes and material for fabrication and surface treatment (other than some specific terms relating to coatings), and terms relating to defects in materials and after optical processing are given in ISO 9802.

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  • Standard
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  • Standard
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This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them.
NOTE Terms are listed in the alphabetical order of the English terms in the English version of this document.

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This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them. NOTE Terms are listed in the alphabetical order of the English terms in the English version of this document.

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IEC 61191-1:2018 is also available as IEC 61191-1:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61191-1:2018 prescribes requirements for materials, methods and verification criteria for producing quality soldered interconnections and assemblies using surface mount and related assembly technologies. This part of IEC 61191 also includes recommendations for good manufacturing processes. This edition includes the following significant technical changes with respect to the previous edition:
- the requirements have been updated to be compliant with the acceptance criteria in IPC‑A-610F;
- the term "assembly drawing" has been changed to "assembly documentation" throughout;
- references to IEC standards have been corrected;
- Clause 9 was completely rewritten;
- Annex B was removed because there are already procedures for circuit board assemblies.

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  • Standard
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This document defines terms in the field of the sterilization of health care products including related equipment and processes.

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  • Standard
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IEC 60050-871:2018 gives the general terminology used in active assisted living, as well as general terms pertaining to specific applications and associated technologies. This terminology is consistent with the terminology developed in the other specialized parts of the IEV.
It has the status of a horizontal standard in accordance with IEC Guide 108.

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ISO 18369-2:2017 specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture.
These tolerances might not apply to other purposes, for example, shelf-life studies.

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