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This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water. This document is applicable to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping or mopping – regardless if they are covered by the Medical Device Regulation [1] or not. Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application methods. This document is applicable for four methods of application of products for wiping and/or mopping: a) soaking any non-specified wipe or mop with product; b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop; c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation; d) pre-impregnation of specified wipes or mops by the manufacturer as ready-to-use wipes or mops. In all types of application the water control has to be conducted with the standard wipe (5.3.2.17 a), because it is process or method control. The contact time for the water control is no longer than 5 min. This document does not apply to products that are sprayed on or used for flooding of surfaces, without wiping or mopping during the contact time. In this case, the methods of phase 2/ step 2 without mechanical action apply. The test-surface (5.3.2.16) was selected as a standard surface and should cover all non-porous surfaces. It was not intended to cover the influence of each different surface. This document is applicable to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: — in hospitals, in community medical facilities and in dental institutions; — in clinics of schools, of kindergartens and of nursing homes; and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients. NOTE This method corresponds to a phase 2, step 2 test. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.

ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

This document specifies the requirements and corresponding test methods for a biocompatible and bio-inert ceramic bone-substitute material based on yttriastabilized tetragonal zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as a material for surgical implants.

This document specifies the common requirements for heat and moisture exchangers (HME), breathing system filters (BSF) and combined devices (HMEF) intended for anaesthetic and respiratory use. It addresses materials, design, performance, requirements for devices supplied sterile, marking, and information to be provided by the manufacturer.

This document specifies requirements for the measurement of moisture loss from heat and moisture exchangers (HMEs), including those incorporating breathing system filters (HMEFs), intended for the humidification of respired gases for use primarily with patients with a tidal volume equal to or greater than 250 ml. Breathing system filters (BSF) are also included in scope, as these devices do some amount of moisture to inspired gases. This document also includes requirements for the measurement of moisture loss from HMEs for use with tracheostomized patients that do not have a machine port and having minimum tidal volumes of 250 mL.

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.

This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen.

Additional requirements for connectors for accessory access connection port

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:

a)   a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;

b)   the pressure outlet of a regulator conforming with ISO 10524-1:2018; or

c)   to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).

This document applies to the following types of flow control devices (FCDs):

a)   flowmeters;

b)   flowgauge FCDs; and

c)   fixed orifice FCDs.

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth cardiovascular fitness and activity monitor devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established in this standard in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability is specified. A common core of communication functionality for personal telehealth cardiovascular fitness and activity monitor devices is defined in this standard.

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva. NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses. This document is addressing in vitro diagnostic examinations including laboratory developed tests and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks as well as institutions and organizations performing biomedical research or sequencing services. This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma. NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses. This document is addressing in vitro diagnostic examinations including laboratory developed tests and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks as well as institutions and organizations performing biomedical research or sequencing services. This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.