IEC 60336:2020 applies to FOCAL SPOTS in medical diagnostic X-RAY TUBE ASSEMBLIES for medical use, operating at X-RAY TUBE VOLTAGES up to and including 150 kV. This document describes the test methods employing digital detectors for determining: a) FOCAL SPOT dimensions in terms of NOMINAL FOCAL SPOT VALUES, ranging from 0,1 to 3,0; b) LINE SPREAD FUNCTIONS; c) one-dimensional MODULATION TRANSFER FUNCTIONS; d) FOCAL SPOT PINHOLE RADIOGRAMS, and the means for indicating compliance. In informative...view more

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This Technical Reports describes quality designations and indications for algae and directly derived products from algae production required for or by pharma producers and industry. It does not apply to Food and Feed sectors.
Note: This TRs does not provide instructions on existing handling of technical requirements in existing legislations.

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    • Technical report
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    • Technical report
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This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus. The functional requirements in this document also apply to inline check valves.

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    • Standard
      12 pages
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      11 pages
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      11 pages
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      10 pages
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      10 pages
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IEC 60522-1:2020 applies to X-RAY TUBE ASSEMBLIES and to FILTERING MATERIAL, in medical diagnostic applications up to a HIGH VOLTAGE of 150 kV. For HIGH VOLTAGES greater than 50 kV, this document applies to X-RAY TUBE ASSEMBLIES with tungsten or tungsten-alloy TARGETS only. IEC 60522-1:2021 defines the concept of PERMANENT FILTRATION of X-RAY TUBE ASSEMBLIES, and it defines the term FILTERING MATERIAL. Methods are given to determine the PERMANENT FILTRATION of an X-RAY TUBE ASSEMBLY and for dete...view more

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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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      19 pages
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      19 pages
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      22 pages
      French language

This document specifies the common requirements for sterilizers used for terminal sterilization of medical devices in health care facilities. This document covers sterilizers that operate with a variety of sterilizing agents (alone or in combination) within a sealed vessel at different temperatures, above, at, or below atmospheric pressure. This document provides high-level requirements and respective test methods that are general in nature. This document does not provide quantitative requiremen...view more

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      46 pages
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    • Technical specification
      46 pages
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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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      22 pages
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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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      32 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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      51 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 the su...view more

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      51 pages
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    • Standard
      56 pages
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      55 pages
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      51 pages
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This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute. This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk mana...view more

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      61 pages
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    • Standard
      61 pages
      French language
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    • Standard
      57 pages
      English language
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      56 pages
      English language

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/validati...view more

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      82 pages
      French language
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      79 pages
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      82 pages
      French language
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    • Standard
      79 pages
      English language

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2. This document includes: — pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure; — details of in vitro and in vivo irritation tes...view more

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      60 pages
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      62 pages
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      65 pages
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      65 pages
      French language

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following: — test sample selection; — selection of representative portions from a medical device; — test sample preparation; — experimental controls; — selection of, and require...view more

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      22 pages
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      26 pages
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      28 pages
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    • Standard
      21 pages
      English language

IEC TR 60601-4-5:2021 provides detailed technical specifications for SECURITY features of MEDICAL DEVICES used in MEDICAL IT-NETWORKS. MEDICAL DEVICES dealt with in this document include MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS and MEDICAL DEVICE SOFTWARE. MEDICAL DEVICE SOFTWARE, although not in the scope of IEC 60601 (all parts), can also make use of this document. Based on the seven foundational requirements described in the state-of-the-art document IEC TS 62443 1 1:2009, thi...view more

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      51 pages
      English language

This document provides ergonomics data for standard developers to use in applying ISO/IEC Guide 71:2014 to address accessibility in standards. These data can also be used by ergonomists and designers to support the development of more accessible products, systems, services, environments, and facilities. The ergonomics data include quantitative data and knowledge about basic human characteristics and capabilities as well as context-specific and task-specific data, all being based on ergonomics re...view more

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      239 pages
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      252 pages
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This document specifies general requirements within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms, and the comparison between the starting materials and the finished products, if necessary.

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      23 pages
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      22 pages
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      23 pages
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This document specifies requirements for identity testing within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms. It is applicable to natural products used in TCM, including starting materials and finished products of herbal origin.

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      17 pages
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      17 pages
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      17 pages
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IEC 60336:2020 applies to FOCAL SPOTS in medical diagnostic X-RAY TUBE ASSEMBLIES for medical use, operating at X-RAY TUBE VOLTAGES up to and including 150 kV.
This document describes the test methods employing digital detectors for determining:
a) FOCAL SPOT dimensions in terms of NOMINAL FOCAL SPOT VALUES, ranging from 0,1 to 3,0;
b) LINE SPREAD FUNCTIONS;
c) one-dimensional MODULATION TRANSFER FUNCTIONS;
d) FOCAL SPOT PINHOLE RADIOGRAMS,
and the means for indicating compliance.
In info...
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      90 pages
      English and French language

This document provides a referenced entry-level implementation template for traditional Chinese medicine decoction piece prescriptions based on HL7 CDA® Release 2.0 to support the data collection, transmission, storage and exchange of decoction piece prescriptions for electronic records. This document focuses on the description of core data of traditional Chinese medicine decoction piece prescriptions which constitute the 'medication administration' section of the clinical document body. This do...view more

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      12 pages
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      12 pages
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This document specifies terminology and test methods for describing the characteristics of
SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) systems designed specifically for
tomographic cardiac imaging. This includes dedicated systems or general purpose systems with
dedicated sub-systems which are not included in the scope of IEC 61675-2.

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      32 pages
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This document specifies requirements and recommendations for healthcare interpreting services in spoken and signed communication. It is applicable to all situations requiring healthcare interpreting, where the parties involved need to communicate using spoken or signed language, to treat a health-related issue. It is intended for interpreting service providers and healthcare interpreters.

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    • Standard
      18 pages
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      19 pages
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    • Standard
      19 pages
      French language
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      18 pages
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      23 pages
      French language
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      20 pages
      English language

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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      67 pages
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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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      63 pages
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      59 pages
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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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      63 pages
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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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      14 pages
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      13 pages
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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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      58 pages
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IEC 60522-1:2020 applies to X-RAY TUBE ASSEMBLIES and to FILTERING MATERIAL, in medical diagnostic applications up to a HIGH VOLTAGE of 150 kV. For HIGH VOLTAGES greater than 50 kV, this document applies to X-RAY TUBE ASSEMBLIES with tungsten or tungsten-alloy TARGETS only.
IEC 60522-1:2021 defines the concept of PERMANENT FILTRATION of X-RAY TUBE ASSEMBLIES, and it defines the term FILTERING MATERIAL.
Methods are given to determine the PERMANENT FILTRATION of an X-RAY TUBE ASSEMBLY and for de...
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      37 pages
      English and French language

This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT). It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does includ...view more

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    • Standard
      39 pages
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      39 pages
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      39 pages
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This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods. NOTE The safety, reliability, biocompatibil...view more

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      81 pages
      English language
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      81 pages
      English language

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...view more

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      18 pages
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      19 pages
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      19 pages
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This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser
equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications,
intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the
ENCLOSED LASER is of CLASS 3B or 4, or CLASS 3B, or CLASS 4.
MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS which incorporate lasers as
sources of energy being transferred to the PATIENT or animal and where the las...
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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.
...
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      68 pages
      English language

IEC 63240-1:2020 specifies the AAL reference architecture.
This document defines concepts and introduces terminology. It provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components.
This document identifies safety, security, privacy, and other requirements for AAL systems such as usability, accessibility, and trustworthiness (reliability, resilience).

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      13 pages
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IEC 63240-2:2020 specifies the AAL architecture model.
This document defines concepts and introduces terminology. IEC 63240-1 provides generic rules for designers of AAL systems and services with the aim to facilitate systems design and enable interoperability between components. This document provides a framework to analyse use cases on a common view and terminology, which is a foundation for communication to discuss the interoperability of the components of the AAL system. This document allow...
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      19 pages
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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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      26 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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      45 pages
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      43 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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      54 pages
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1.1   This European Standard deals with safety requirements for construction, manufacturing, installation, maintenance and dismantling of electrically operated stairlifts (chair, standing platform and wheelchair platform) affixed to a building structure, moving in an inclined plane and intended for use by persons with impaired mobility:
-   travelling over a stair or an accessible inclined surface;
-   intended for use by one person;
-   whose carriage is directly retained and guided by a guide rail ...
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      79 pages
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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. *...view more

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    • Standard
      68 pages
      French language
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    • Standard
      68 pages
      English language
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      73 pages
      French language
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    • Draft
      67 pages
      English language

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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      18 pages
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      15 pages
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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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      36 pages
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      33 pages
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    • Standard
      1 page
      French language
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    • Standard
      1 page
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      1 page
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      1 page
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      7 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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      16 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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      34 pages
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    • Standard
      1 page
      French language
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      1 page
      English language
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    • Standard
      1 page
      English language
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    • Draft
      1 page
      French language

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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    • Draft
      68 pages
      French language
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    • Draft
      62 pages
      English language