This document specifies requirements and recommendations for the pre-examination phase of human specimens, including saliva, skin, urine and stool, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, storage, processing and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnos...
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      37 pages
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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 system...
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MINOR REVISION

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This document presents guidelines for the design and development of cognitively accessible systems, including products and services and built environments.
This document is relevant to mainstream systems as well as those designed specifically for people with disability.
Within the broad field of accessibility, this document is limited to guidance related to cognitive accessibility.
NOTE 1 It acknowledges, however, that diverse sensory perceptions can impact cognitive accessibility.
NOTE 2 Wh...
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    • Standard
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      28 pages
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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis model.

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    • Standard
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    • Standard
      41 pages
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This document specifies requirements for check valves intended for single use and used with infusion equipment for gravity-feed infusion and/or with pressure infusion apparatus.
NOTE   The functional requirements in this document also apply to built-in check valves.

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      18 pages
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This document specifies the classification of and requirements for dental casting and dental baseplate
waxes together with the test methods to be employed to determine compliance with these requirements.
This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based
procedures.

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      28 pages
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This document is applicable to heart valve substitutes intended for implantation in human hearts,
generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for
examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and
to the accessory devices, packaging, and labelling required for their implantation and for determining
the appropriate size of t...
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This document is applicable to heart valve substitutes intended for implantation and provides general
requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
This document is applicable to newly developed and modified heart valve substitutes and to the
accessory devices, packaging, and labelling required for their implantation and for determining the
appropriate size of the heart valve substitute to be implanted.
ISO 5840-1 outlines an approach for verifying/val...
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This document specifies requirements for electrically heated shell boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar ∙ l.

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    • Standard
      22 pages
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This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk
management process;
— the general categorization of medical devices based on the nature and duration of their contact with
the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of t...
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This document specifies requirements for controls on the sourcing, collection, and handling (which
includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing
materials of animal origin other than in vitro diagnostic medical devices. It applies where required by
the risk management process as described in ISO 22442-1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk
management, i.e. when utilis...
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This document applies to medical devices other than in vitro diagnostic medical devices manufactured
utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It
specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations
associated with such devices, to estimate and evaluate the resulting risks, to control these risks,
and to monitor the effectiveness of that control. Furthermore, it outlines the decision process ...
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    • Standard
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This particular standard is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as me equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.
This particular standard is also applicable to those accessories in...
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This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers,
but not to other ophthalmic instruments which are used in contact with the globe of the eye.
This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

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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 particular standard 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 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.
This particu...
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This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircra...view more

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2020-05-29 PeC: to be offerered for MD
2020-04-30: This A11 will introduce revised Annex ZA for EN ISO 11553-1:2020. Both mother standard and A11 will be offered to OJEU for citation

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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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      45 pages
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This European Standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport, monitoring, treatment and care of patients. It contains requirements for the patient’s compartment in terms of the working environment, ergonomic design and the safety of the crew and patients.This European Standard does not cover the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be re...view more

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This document classifies polymer-based crown and veneering materials used in dentistry and specifies
their requirements. It also specifies the test methods to be used to determine conformity to these
requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated
permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials
for which the manufacturer claims adhesion to the substructure without macro-mech...
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This document specifies general requirements and test methods for accuracy of electronic apex locator that use more than two different frequencies to determine root canal length during root canal treatment.

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This document specifies particular requirements for the biocompatibility evaluation of materials for
intraocular lenses (IOLs) including the processing conditions to produce them. These requirements
include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives
guidance on conducting an ocular implantation test.

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    • Standard
      36 pages
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This document specifies requirements and test methods for total digestible fluoride content and a
minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use
in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies packaging and
labelling requirements, including the instructions for use. This document covers fluoride varnishes to
be applied by dental health care workers.

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      19 pages
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This document specifies dimensions and requirements for both open and closed suction catheters made
of flexible materials and intended for use in suctioning of the respiratory tract.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
equipment are not covered by this document.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

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    • Standard
      32 pages
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This document specifies requirements for the evaluation of stent systems (vascular stents and delivery
systems) 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 Annex D. This document is supplemental to ISO 14630, which specifies
general requirements for the performance of non-active surgical implants.
NOTE 1 Due to the vari...
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This document specifies a framework for the identification, and if necessary, quantification of
constituents of a medical device, allowing the identification of biological hazards and the estimation
and control of biological risks from material constituents, using a generally stepwise approach to the
chemical characterization which can include one or more of the following:
— the identification of its materials of construction (medical device configuration);
— the characterization of the mat...
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This International Standard describes requirements for tooth-like colour representations made of
ceramic materials used to determine the tooth colour in the patient’s mouth or to check the colour of
dental prosthesis, which are referred to as shade guides (colour rings) in this standard.
The coordinates of tooth colours in the colour space (colour coordinates) the specification of which is left
to the manufacturers’ discretion as well as the colour deviations of ceramic and other masses or m...
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This document, which is device-specific, specifies requirements for laryngoscopes with non-flexible
blades, with internal battery-operated power sources, used for illuminating the larynx during
intubation. It also specifies critical dimensions for those handles and laryngoscope blades with
interchangeable hook‐on fittings.
It is not applicable to the following:
— flexible laryngoscopes;
— laryngoscopes designed for surgery;
— laryngoscopes powered from mains electricity supply;
— laryngo...
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This document specifies test methods and procedures to determine the corrosion behaviour of metallic
materials used in the oral cavity. It is intended that these test methods and procedures be referred to in
individual International Standards specifying such metallic materials.
This document is not applicable to dental instruments.

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This document specifies requirements and test methods for hand-held and mechanically operated
instruments used for shaping and cleaning root canals, and which are not specified in other parts of the
ISO 3630 series.
This document specifies requirements for size, marking, product designation, safety considerations,
labelling and packaging.

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      15 pages
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This document specifies requirements and test methods for the physical properties of powered
toothbrushes in order to promote the safety of these products for their intended use.
There are different technologies of powered toothbrushes. Common features of those powered
toothbrushes to which this document applies are:
— a battery;
— a motor;
— a mechanical or magnetic drive system;
— a moving brush head with tufted filaments.
Powered toothbrushes can have a moving brush head with differen...
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      25 pages
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This document provides a nomenclature of oral anomalies and a code for their representation to facilitate data entry and support interoperability at the semantic level.
This nomenclature covers the various anomalies that can be found in the oral cavity. When needed, information on the localization of the anomaly can be added through the use of other codes such as ISO 3950.

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This document provides a nomenclature of oral developmental disturbances of teeth and a code for their representation to facilitate data entry and support interoperability at the semantic level.
This nomenclature covers the various developmental disturbances of teeth.

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This document addresses good clinical practice for the design, conduct, recording and reporting of
clinical investigations carried out in human subjects to assess the clinical performance or effectiveness
and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be
followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies general requirements intended to
— ...
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The proposed Technical Report is to provide a common understanding of post-market surveillance, or
PMS facilitating international cooperation in this area. The Technical Report is intended for use by
manufacturers of medical devices. With PMS, the manufacturers can collect, evaluate, and analyze experience gained with their devices after placing on the market. The resulting information can be used for, among others, improvement of the devices.
The proposed Technical Report aims to describe a ...
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This document specifies requirements and test methods for assessing the applicability of dental
magnetic attachments that provide retention, support and stabilization of removable prostheses
(crowns and bridges, partial dentures and overdentures), superstructures of dental implants and
orthodontic or maxillofacial prostheses including obturators.

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      21 pages
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This document provides guidance on the development, implementation and maintenance of a risk
management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based
on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016
(Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are
related to risk management and can b...
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This document applies to central compressed air source equipment for dental compressed air used in dentistry. It specifies functional requirements for compressed air source equipment and quality requirements for the dental compressed air produced by the compressed air source equipment.
This International Standard specifies the purity level of dental compressed air and test procedures for central compressed air source equipment and test procedures for the quality requirements for dental compress...
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This International Standard gives the requirement for the permissible reduction in strength resulting
from crevice corrosion of dental amalgam products that are within the scope of ISO 24234: Dentistry –
Dental amalgam and ISO 20749: Dentistry – Pre-capsulated dental amalgam. It provides details of the
test procedure for determining this.

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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 describes one reference method, broth micro-dilution, for determination of MICs.
The MIC can be a guide for the clinician, and reflects the activity of the drug under the described
test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics,
or bacterial resistance mechanisms. This allows categorisation of bacteria as “susceptible” (S),
“intermediate” (I), or “resistant” (R). In addition, MIC distributions can be used to define wild type
...
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This document is intended especially to ensure the gas-specific assembly, mechanical resistance, flow,
leakage and pressure drop of terminal units and to prevent their interchange between different gases
and services and applies to terminal units:
a) intended for use in medical gas pipeline systems in accordance with ISO 7396-1;
b) used as pressure outlets on pressure regulators in accordance with ISO 10524-1;
c) used as pressure outlets on pressure regulators integrated with cylinder valve...
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