This document specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking. This document is not applicable to: a) powered polymerization activators for polymerization of dental materials; b) exclusively extraoral camera equipment to prepare overviews or to record treatments; c) den...view more

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    • Standard
      18 pages
      English language
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    • Standard
      18 pages
      French language
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    • Draft
      18 pages
      English language
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    • Draft
      18 pages
      French language

This document applies to basic safety and essential performance of cerebral tissue oximeter equipment, that employs light at multiple wavelengths to derive a quantitative measure of oxygen saturation of haemoglobin within the volume of tissue sampled under the probe attached to the head. The cerebral tissue oximeter equipment can be based on continuous light, frequency domain or time domain technologies. This document applies to ME equipment used in a hospital environment as well as when used ou...view more

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    • Standard
      107 pages
      English language
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    • Standard
      108 pages
      English language
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    • Standard
      128 pages
      French language
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    • Standard
      126 pages
      French language

1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2. 1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

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    • Technical specification
      13 pages
      English language
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      13 pages
      English language
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    • Standard
      28 pages
      English language
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This document specifies the general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment. NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants. This document also applies to instruments which can be connected to power-driven systems, but it does no...view more

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    • Standard
      14 pages
      English language
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    • Standard
      16 pages
      French language
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    • Draft
      14 pages
      English language
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    • Draft
      16 pages
      French language

This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).

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    • Technical specification
      12 pages
      English language
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      12 pages
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    • Standard
      1 page
      English language
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      1 page
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IEC 61828:2020 - provides definitions for the transmitted field characteristics of focusing and nonfocusing transducers for applications in medical ultrasound; - relates these definitions to theoretical descriptions, design, and measurement of the transmitted fields of focusing transducers; - gives measurement methods for obtaining defined field characteristics of focusing and nonfocusing transducers; - specifies beam axis alignment methods appropriate for focusing and nonfocusing transducers. I...view more

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    • Standard
      115 pages
      English language
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This document specifies the requirements and their test methods for elastomeric impression and bite registration materials. NOTE This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series.

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    • Standard
      33 pages
      English language
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    • Standard
      35 pages
      French language
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      33 pages
      English language

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document s...view more

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    • Standard
      24 pages
      English language
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    • Standard
      26 pages
      French language
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    • Draft
      24 pages
      English language

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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    • Standard
      60 pages
      English language
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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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    • Standard
      87 pages
      English language
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      1 day

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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    • Standard
      47 pages
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This document provides a test method for determining the sum of residual monomeric sodium acrylate and acrylic acid present in polyacrylate superabsorbent powders as acrylic acid.

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    • Standard
      10 pages
      English language
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      10 pages
      English language

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
      39 pages
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    • Technical report
      39 pages
      English language
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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
      11 pages
      English language
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    • Standard
      12 pages
      French language
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      11 pages
      English language

This document 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.
NOTE 1 The FILTERING MATERIAL in the X-RAY BEAM can be removable or irremovable; it can be positioned in any
orientation or can have any shape (e.g. tapering thickness) – although usually plane-parallel material, perpendicul...
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    • Standard
      22 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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    • Standard
      19 pages
      English language
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    • Standard
      19 pages
      French language
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    • Draft
      19 pages
      English 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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    • Technical specification
      46 pages
      English language
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    • Technical specification
      48 pages
      French language
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      46 pages
      English language

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
      37 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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    • Standard
      26 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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    • Standard
      50 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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    • Standard
      57 pages
      English language
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    • Standard
      57 pages
      English language
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    • Standard
      61 pages
      French language
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    • Standard
      61 pages
      French language
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    • Draft
      56 pages
      English language
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    • Draft
      61 pages
      French language

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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    • Standard
      51 pages
      English language
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    • Standard
      51 pages
      English language
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    • Standard
      56 pages
      French language
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    • Standard
      56 pages
      French language
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    • Draft
      51 pages
      English language
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    • Draft
      55 pages
      French language
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    • Amendment
      7 pages
      English language
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    • Amendment
      4 pages
      English language
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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/validati...view more

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    • Standard
      79 pages
      English language
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    • Standard
      79 pages
      English language
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    • Standard
      82 pages
      French language
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    • Standard
      82 pages
      French language
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    • Draft
      79 pages
      English language
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    • Draft
      82 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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    • Standard
      21 pages
      English language
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    • Standard
      22 pages
      French language
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    • Draft
      26 pages
      English language
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    • Draft
      28 pages
      French 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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    • Standard
      60 pages
      English language
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    • Standard
      62 pages
      French language
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    • Standard
      62 pages
      French language
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    • Draft
      65 pages
      English language
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    • Draft
      65 pages
      French 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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    • Technical report
      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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    • Technical report
      239 pages
      English language
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    • Draft
      252 pages
      English language

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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    • Standard
      17 pages
      English language
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      17 pages
      English language

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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    • Standard
      22 pages
      English language
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    • Draft
      23 pages
      English language

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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    • Standard
      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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    • Technical specification
      12 pages
      English language
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      12 pages
      English language

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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    • Standard
      32 pages
      English language
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      1 day

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
      English language
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    • Standard
      19 pages
      French language
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    • Draft
      18 pages
      English language
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    • Draft
      19 pages
      French language

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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    • Standard
      14 pages
      English language
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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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    • Standard
      63 pages
      English language
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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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    • Standard
      67 pages
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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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    • Standard
      79 pages
      English language
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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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    • Standard
      73 pages
      English language
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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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    • Standard
      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
      English language
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    • Standard
      39 pages
      English language
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    • Draft
      39 pages
      English language

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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    • Standard
      81 pages
      English language
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    • Draft
      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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    • Standard
      18 pages
      English language
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    • Draft
      19 pages
      English language

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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    • Standard
      68 pages
      English language

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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    • Standard
      33 pages
      English language
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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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    • Standard
      19 pages
      English language