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This document specifies the determination of the bulk crystallinity (crystalline contribution relative to the total crystalline and amorphous contributions in the material) of cellulose nanomaterials using powder X-ray diffraction followed by deconvolution of the diffraction patterns based on Rietveld analysis. It is applicable to all types of cellulose nanomaterials, assuming a representative sample.

This document describes a method for performing positron annihilation lifetime measurements using a 22Na positron source that decays with β+ emission. The β+ (positron) lifetime is determined from a measurement of the lifetime of the ortho-positronium which ranges from 1 ns to 10 ns (ascribed to a pore size from approximately 0,3 nm to 1,3 nm in diameter), as observed for polymeric materials in which the positronium atoms mostly annihilate via a two-gamma annihilation process. This document is not applicable to thin surface layers (that are less than several micrometers). This document does not apply to measuring: — non-positronium forming materials; — positronium-forming materials that induce a spin conversion reaction; — positronium-forming materials that contain chemicals influencing the annihilation process of ortho-positronium by chemical reactions; — positronium-forming materials that contain mesoporous silica gels with a large contribution from the three-gamma annihilation process.

This document provides an overview of the methods used to determine the nanoparticle number concentration in liquid dispersions and aerosols. The methods described are the ensemble measurement techniques of differential centrifugal sedimentation (DCS), multi-angle dynamic light scattering (MDLS), small-angle X-ray scattering (SAXS) and ultraviolet-visible spectroscopy (UV-vis) and the particle counting methods of particle tracking analysis (PTA), resistive pulse sensing (RPS), single particle inductively coupled plasma mass spectrometry (spICP-MS), condensation particle counter (CPC), and differential mobility analysing system (DMAS). This document provides information on the use of each technique, along with considerations on sample preparation, advantages and limitations.

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment: ¾ intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; NOTE 2 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining. NOTE 3 For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator). NOTE 4 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator. ¾ intended to be operated by a healthcare professional operator; and ¾ intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. A critical care ventilator is not considered to use a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. 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. NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation. NOTE 7 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining. This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. This document does not specify the requirements for: NOTE 8 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. ¾ ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13; ¾ ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84; ¾ ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72; ¾ ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80; ¾ obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70; ¾ continuous positive airway pressure (CPAP) ME equipment. ¾ high-frequency ventilators, which are given in ISO 80601‑2‑87; NOTE 9 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes. ¾ respiratory high-flow therapy equipment, which are given in ISO 80601‑2‑90; NOTE 10 A critical care ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing p

This document specifies a mild oxidation method to determine the content of carbon impurities (carbon material content not in the form of CNT, including amorphous carbon and trace amountd of other types of structured carbon) less stable than multiwall carbon nanotubes (MWCNTs) by thermogravimetric analysis (TGA) under carbon dioxide atmosphere. This document is applicable to the characterization of carbon impurities content in MWCNT samples prepared by chemical vapour deposition (CVD). Measurement of carbon impurities in MWCNT samples prepared by other methods can refer to this document. This method is not applicable to functionalized MWCNT samples or MWCNT samples with encapsulant species. NOTE This method is applicable for the case of TG curves with a single-stage.

This document defines core terms in the field of nanotechnology. This document is intended to facilitate communication between organizations and individuals in industry and those who interact with them.

This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range. Example user-powered resuscitators include: — self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations. — flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source. This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator. Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment. This document is also applicable to point-of-use packaging. This document does not specify the requirements for: — gas-powered emergency resuscitators, which are given in ISO 10651-5; — electrically-powered resuscitators; — gas powered resuscitators for professional healthcare facilities; and — anaesthetic reservoir bags, which are given in ISO 5362. NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D. NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E. NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.

This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period. A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure, diastolic blood pressure or mean arterial pressure) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer. This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation. Representation of output is not covered by this document. NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values. The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers. NOTE 2 Subject populations can, for example, be represented by age or weight ranges. NOTE 3 This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject). This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document. This document is not applicable to: — the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1, — the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060-2, — an automated non-invasive sphygmomanometer as given in IEC 80601-2-30, or — invasive blood pressure monitoring equipment as given in IEC 60601‑2‑34.

This document specifies conformance tests in the form of an abstract test suite (ATS) for a system under test (SUT) implementing an electric-vehicle or supply-equipment communication controller (EVCC or SECC) with support for WLAN-based high-level communication (HLC) according to ISO 15118‑8 and against the background of ISO 15118-1. These conformance tests specify the testing of capabilities and behaviours of an SUT, as well as checking what is observed against the conformance requirements specified in ISO 15118‑8 and against what the implementer states the SUT implementation's capabilities are. The capability tests within the ATS check that the observable capabilities of the SUT are in accordance with the static conformance requirements defined in ISO 15118‑8. The behaviour tests of the ATS examine an implementation as thoroughly as practical over the full range of dynamic conformance requirements defined in ISO 15118‑8 and within the capabilities of the SUT (see NOTE below). A test architecture is described in correspondence to the ATS. The abstract test cases in this document are described leveraging this test architecture and are specified in descriptive tabular format for the ISO/OSI physical and data link layers (layers 1 and 2). In terms of coverage, this document only covers normative sections and requirements in ISO 15118‑8. This document can additionally refer to specific tests for requirements on referenced standards (e.g. IEEE, or industry consortia standards, like WiFi Alliance) as long as they are relevant in terms of conformance for implementations according to ISO 15118‑8. However, it is explicitly not intended to widen the scope of this conformance specification to such external standards, if it is not technically necessary for the purpose of conformance testing for ISO 15118‑8. Furthermore, the conformance tests specified in this document do not include the assessment of performance nor robustness or reliability of an implementation. They cannot provide judgments on the physical realization of abstract service primitives, how a system is implemented, how it provides any requested service, nor the environment of the protocol implementation. Furthermore, the abstract test cases defined in this document only consider the communication protocol and the system's behaviour defined ISO 15118‑8. The power flow between the EVSE and the EV is not considered. NOTE Practical limitations make it impossible to define an exhaustive test suite, and economic considerations can restrict testing even further. Hence, the purpose of this document is to increase the probability that different implementations are able to interwork. This is achieved by verifying them by means of a protocol test suite, thereby increasing the confidence that each implementation conforms to the protocol specification. However, the specified protocol test suite cannot guarantee conformance to the specification since it detects errors rather than their absence. Thus, conformance to a test suite alone cannot guarantee interworking. Instead, it gives confidence that an implementation has the required capabilities and that its behaviour conforms consistently in representative instances of communication.

This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; — intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and — intended for transit-operable use. NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor. EXAMPLE probes, cables distributed alarm system

This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: anaesthetic gas delivery system; anaesthetic breathing system; anaesthetic gas scavenging system (AGSS); anaesthetic vapour delivery system; anaesthetic ventilator; monitoring equipment; alarm system; protection device. NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1. An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard. NOTE 2 The applicability of this document is indicated in Table AA.2. This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components including accessories, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

This document specifies the communication between the electric vehicle (EV), including battery electric vehicle (BEV) and plug-in hybrid electric vehicle (PHEV), and the electric vehicle supply equipment (EVSE). The application layer messages defined in this document are designed to support the electricity power transfer between an EV and an EVSE. This document defines the communication messages and sequence requirements for bidirectional power transfer. This document furthermore defines requirements of wireless communication for both conductive charging and wireless charging as well as communication requirements for automatic connection device and information services about charging and control status. The purpose of this document is to detail the communication between an electric vehicle communication controller (EVCC) and a supply equipment communication controller (SECC). Aspects are specified to detect a vehicle in a communication network and enable an Internet Protocol (IP) based communication between the EVCC and the SECC.

This document provides guidance and requirements for the determination of the mean (spherical) equivalent diameter of nano-objects (i.e. particles, droplets or bubbles) dispersed in liquids using the static multiple light scattering (SMLS) technique. The technique is applicable to a wide range of materials and does not require dilution of concentrated samples.

This document specifies requirements and recommendations for the identification of measurands to characterize nano-objects and their agglomerates and aggregates, and to assess specific properties relevant to the performance of materials that contain them. It provides recommendations for relevant measurement.

This document describes methods for the measurement of particle size distributions for cellulose nanocrystals using atomic force microscopy and transmission electron microscopy. The document provides a protocol for the reproducible dispersion of the material using ultrasonication, as assessed using dynamic light scattering. Sample preparation for microscopy, image acquisition and data analysis are included.

This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders. IEC 80001-1:2021 cancels and replaces the first edition published in 2010. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) structure changed to better align with ISO 31000; b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT; c) communication of the value, intention and purpose of RISK MANAGEMENT through principles that support preservation of the KEY PROPERTIES during the implementation and use of connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.

This document provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps. This document is applicable to health apps, which are a special form of health software. It covers the entire life cycle of health apps. This document is intended for use by app manufacturers as well as app assessment organizations in order to communicate the quality and reliability of a health app. Consumers, patients, carers, health care professionals and their organizations, health authorities, health insurers and the wider public can use the health app quality label and report when recommending or selecting a health app for use, or for adoption in care guidelines, care pathways and care contracts. NOTE 1 Health apps can be subject to national legislation, such as for medical devices. NOTE 2 See Annex C for additional details on the scope. Outside the scope of this document are guidelines to comply to the medical device regulation.

This document is applicable to protectors intended to provide protection against accidental exposure to laser radiation within the wavelength range 180 nm to 1 mm. It specifies the requirements, test methods and marking. Protectors intended for adjustment work on lasers are included in the scope of this document and are marked in the same way as other protectors, but selection of appropriate eyewear for a specific application is a choice of the user. Laser protective filters used as viewing windows in laser equipment machinery or incorporated into optical instruments such as operating microscopes and loupes that may be used for deliberate viewing of laser radiation as part of their function are outside the scope of this document. Laser radiation in the wavelength range below 180 nm is absorbed in air, therefore eye and face protection should not be required. This document is applicable to devices intended for patient protection during medical laser procedures except for treatment in the periorbital area. Guidance on eye protectors for patients (including those used for periorbital treatment) is given in ISO/TR 22463.

This document describes methods for the quantification of nano-object release from powders as a result of treatment, ranging from handling to high energy dispersion, by measuring aerosols liberated after a defined aerosolization procedure. Particle number concentration and size distribution of the aerosol are measured and the mass concentration is derived. This document provides information on factors to be considered when selecting among the available methods for powder sampling and treatment procedures and specifies minimum requirements for test sample preparation, test protocol development, measuring particle release and reporting data. In order to characterize the full size range of particles generated, the measurement of nano-objects as well as agglomerates and aggregates is adressed in this document. This document does not include the characterization of particle sizes within the powder. Tribological methods are excluded where direct mechanical friction is applied to grind or abrade the material.

This document defines terms related to the characterization of nano-objects in the field of nanotechnologies. It is intended to facilitate communication between organizations and individuals in research, industry and other interested parties and those who interact with them.

This document specifies the sequence of methods for characterizing the structural properties of graphene, bilayer graphene and graphene nanoplatelets from powders and liquid dispersions using a range of measurement techniques typically after the isolation of individual flakes on a substrate. The properties covered are the number of layers/thickness, the lateral flake size, the level of disorder, layer alignment and the specific surface area. Suggested measurement protocols, sample preparation routines and data analysis for the characterization of graphene from powders and dispersions are given.

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, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3). This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions. This document does not specify all connector features. This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system. NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.

This document defines terms related to nanomanufacturing processes in the field of nanotechnologies. All the process terms in this document are relevant to nanomanufacturing, however, many of the listed processes are not exclusively relevant to the nanoscale. Terms that are not exclusive are noted within the definitions. Depending on controllable conditions, such processes can result in material features at the nanoscale or, alternatively, at larger scales. There are many other terms that name tools, components, materials, systems control methods or metrology methods associated with nanomanufacturing that are beyond the scope of this document. Terms and definitions from other parts of the ISO/TS 80004 series are reproduced in Clause 3 for context and better understanding.

This document defines terms related to carbon nano-objects in the field of nanotechnologies. It is intended to facilitate communication between organizations' and individuals' research, industry and other interested parties and those who interact with them. Additional terms and definitions for graphene and two-dimensional materials (2D) materials are provided in ISO/TS 80004-13. Related carbon nanoscale materials are given in Annex A.

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. * Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[13]. This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[8]. This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72[9]. This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84[12]. This document does not specify the requirements for ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79[10] and ISO 80601‑2‑80[11].

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 aircraft. NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities. This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems. EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function. EXAMPLE 2 An oxygen concentrator used with a flowmeter stand. EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2]. EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function. This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator. NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE 3 See also 4.2 of the general standard.

This document 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. NOTE 1 Conserving equipment can also be used in professional health care facilities. This document is also applicable to conserving equipment that is incorporated with other equipment. EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4]. This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling. This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

This document specifies how to capture, measure and analyse transmission electron microscopy images to obtain particle size and shape distributions in the nanoscale. This document broadly is applicable to nano-objects as well as to particles with sizes larger than 100 nm. The exact working range of the method depends on the required uncertainty and on the performance of the transmission electron microscope. These elements can be evaluated according to the requirements described in this document.

This document describes laser radiation hazards arising in laser processing machines, as defined in 3.7. It also specifies the safety requirements relating to laser radiation hazards, as well as the information to be supplied by the manufacturers of such equipment (in addition to that prescribed by IEC 60825). Requirements dealing with noise as a hazard from laser processing machines are included in ISO 11553‑3:2013. This document is applicable to machines using laser radiation to process materials. It is not applicable to laser products, or equipment containing such products, which are manufactured solely and expressly for the following applications: — photolithography; — stereolithography; — holography; — medical applications (per IEC 60601-2-22); — data storage.

This document gives guidelines for the characterization of carbon nanotube (CNT)-containing samples by thermogravimetric analysis (TGA), performed in either an inert or oxidizing environment. Guidance is provided on the purity assessment of the CNT samples through a quantitative measure of the types of carbon species present as well as the non-carbon impurities (e.g. metal catalyst particles) within the material. In addition, this technique provides a qualitative assessment of the thermal stability and homogeneity of the CNT-containing sample. Additional characterization techniques are required to confirm the presence of specific types of CNT and to verify the composition of the metallic impurities present.

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. This document does not apply to: — decisions on the use of a medical device in the context of any particular clinical procedure; or — business risk management. This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place. NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].

This document gives guidelines for the characterization of single-wall carbon nanotubes (SWCNTs) using near infrared (NIR) photoluminescence (PL) spectroscopy. It provides a measurement method for the determination of the chiral indices of the semi-conducting SWCNTs in a sample and their relative integrated PL intensities. The method can be expanded to estimate the relative mass concentrations of semi-conducting SWCNTs in a sample from their measured integrated PL intensities and knowledge of their PL cross-sections.

This document specifies a method for the characterization of evolved gas components in single-wall carbon nanotube (SWCNT) samples using evolved gas analysis/gas chromatograph mass spectrometry (EGA/GCMS). NOTE Some difference could appear between qualitative and quantitative results of emitted gas and gas content in the sample due to the heating and the possible presence of catalysts.

This document focuses on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices and health information systems. This document specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections. This document provides practical examples of risk analysis to protect both the HCF and RMS provider information assets in a safe and efficient (i.e. economical) manner. These assets are primarily the information system itself and personal health data held in the information system.

This document provides guidelines to quantify and identify air concentration (number of particles/cm3) of particles of carbon black and/or amorphous silica by size in air samples collected in a mixed dust industrial manufacturing environment. The method is defined for air samples collected with an electrical low pressure cascade impactor (ELPCI). on a 25 mm polycarbonate substrate. The method is suitable for sampling in manufacturing environments where there are a variety of particle types contributing to the overall atmosphere. This method is applicable only to environments with chemically and physically distinct particles contributing to aerosols or when confounders can be controlled (e.g. diesel sources). Other sampling methods can also be suitable, though this document is limited to describing methods associated with the electrical low pressure cascade impactor. Samples collected with the electrical low pressure cascade impactor are analyzed via TEM and EDS to for particle morphology and elemental composition, respectively, to permit identification of particles by type. This information is then used, in conjunction with particle concentration by size range, as determined by the electrical low pressure cascade impactor, to determine concentration of the materials of interest by size.

This document provides guidance for some methods that could be used to evaluate the sources of uncertainty. It is important to note that there are many legitimate methods for analyzing the overall uncertainty and that the methods in this document are illustrative only.

ISO/IEC 80079-34:2018 specifies particular requirements and information for establishing and maintaining a quality management system to manufacture Ex Products in accordance with the certificates. While it does not preclude the use of other quality management systems that are compatible with the objectives of ISO 9001:2015 and which provide equivalent results, the minimum requirements are given in this document. This second edition cancels and replaces the first edition, published in 2011, and constitutes a full technical revision. The significant changes with respect to the previous edition should be considered as minor technical revisions. However, the clause numbering in regard to the previous edition has changed in order to be in line with ISO 9001:2015. The normal “Table of Significant Changes” has not been included for this reason. This publication is published as a double logo standard. This standard should be read in conjunction with ISO 9001:2015

This document considers and identifies criteria about the intended patient, intended use environment, and intended operator across the spectrum of the types of ventilation-related equipment as listed below: — gas-powered resuscitator as specified in ISO 10651-5[1] [1]; — operator-powered resuscitator as specified in ISO 10651-4[2]; — ventilator for critical care as specified in ISO 80601-2-12[3] [2]; — ventilator for emergency medical services environment as specified in ISO 80601-2-84[4] [3], the future replacement for ISO 10651-3[5]; NOTE 1 ISO 80601‐2‐84 updates the content of ISO 10651‐3 and harmonizes it with IEC 60601-1:2005+AMD1:2012[6] and IEC 60601-1-12:2014[7]. — ventilator for ventilatory impairment in the home healthcare environment as specified in ISO 80601‑2‑79[8]; — ventilator for ventilatory insufficiency in the home healthcare environment as specified in ISO 80601‑2‑80[9]; — ventilator for ventilator-dependent patients in the home healthcare environment as specified in ISO 80601-2-72[10]; — sleep apnoea breathing therapy equipment as specified in ISO 80601-2-70[11]. NOTE 2 Sleep apnoea breathing therapy equipment is not considered to be an artificial ventilator. It is included in this discussion to highlight the differences, which indicate why sleep apnoea breathing therapy equipment is not considered a ventilator. This document is intended to provide guidance that can assist manufacturers, authorities having jurisdiction and users in the development, selection and application of different types of ventilatory equipment based on the intended patient, intended use environment and intended operator. [1] Numbers in square brackets refer to the Bibliography. [2] Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-12:2018. [3] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2018.

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory insufficiency, as defined in 201.3.204, hereafter also referred to as me equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; — intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation; — intended for transit-operable use; — not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy. NOTE 1 In the home healthcare environment, the supply mains is often not reliable. NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 3 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2. This document does not specify the requirements for: — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[5]; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[6][1], the future replacement for ISO 10651‑3[7]; — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; — ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79[1]; — sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[8]; — continuous positive airway pressure (CPAP) me equipment; — high-frequency jet ventilators (HFJVs); — high-frequency oscillatory ventilators (HFOVs)[9]; — oxygen therapy constant flow me equipment; — cuirass or "iron-lung" ventilation equipment. This document is a particular standard in the IEC 60601 and IEC/ISO 80601 series of documents. [1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; and — intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and — not intended for patients who are dependent on artificial ventilation for their immediate life support. EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD). NOTE 1 In the home healthcare environment, the supply mains is often not reliable. NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment. EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 3 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2. This document does not specify the requirements for: — ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12; — ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[4]; — ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84 [5] [1], the future replacement for ISO 10651‑3[6]; — ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72; — ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80[1]; — sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[7]; — continuous positive airway pressure (CPAP) me equipment; — high-frequency jet ventilators (HFJVs); — high-frequency oscillatory ventilators (HFOVs)[8]; — oxygen therapy constant flow me equipment; — cuirass or "iron-lung" ventilation equipment. This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents. [1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

This document identifies parameters and conditions, as part of an integrated measurement system, necessary to develop and validate methods for the application of asymmetrical-flow and centrifugal field-flow fractionation to the analysis of nano-objects and their aggregates and agglomerates dispersed in aqueous media. In addition to constituent fractionation, analysis can include size, size distribution, concentration and material identification using one or more suitable detectors. General guidelines and procedures are provided for application, and minimal reporting requirements necessary to reproduce a method and to convey critical aspects are specified.

ISO/IEC 80079-20-1:2017 is published as a dual log standard and provides guidance on classification of gases and vapours. It describes a test method intended for the measurement of the maximum experimental safe gaps (MESG) for gas-air mixtures or vapour-air mixtures under normal conditions of temperature and pressure (20 °C, 101,3 kPa) so as to permit the selection of an appropriate group of equipment. This document also describes a test method intended for use in the determination of the auto-ignition temperature (AIT) of a vapour-air mixture or gas-air mixture at atmospheric pressure, so as to permit the selection of an appropriate temperature class of equipment. Values of chemical properties of materials are provided to assist in the selection of equipment to be used in hazardous areas. Further data may be added as the results of validated tests become available. The materials and the characteristics included in a table (see Annex B) have been selected with particular reference to the use of equipment in hazardous areas. The data in this document have been taken from a number of references which are given in the bibliography. These methods for determining the MESG or the AIT may also be used for gas-air-inert mixtures or vapour-air-inert mixtures. However, data on air-inert mixtures are not tabulated. Keywords: classification of gases and vapours, measurement of the maximum experimental safe gaps (MESG)

ISO/TS 11888:2017 describes methods for the characterization of mesoscopic shape factors of multiwall carbon nanotubes (MWCNTs). Techniques employed include scanning electron microscopy (SEM), transmission electron microscopy (TEM), viscometry, and light scattering analysis. ISO/TS 11888:2017 also includes additional terms needed to define the characterization of static bending persistence length (SBPL). Measurement methods are given for the evaluation of SBPL, which generally varies from several tens of nanometres to several hundred micrometres. Well-established concepts and mathematical expressions, analogous to polymer physics, are utilized for the definition of mesoscopic shape factors of MWCNTs.

ISO/TS 10868:2017 provides guidelines for the characterization of compounds containing single-wall carbon nanotubes (SWCNTs) by using optical absorption spectroscopy. The aim of this document is to describe a measurement method to characterize the diameter, the purity, and the ratio of metallic SWCNTs to the total SWCNT content in the sample. The analysis of the nanotube diameter is applicable for the diameter range from 1 nm to 2 nm.

ISO/TR 13154:2017 provides general guidelines for the deployment, implementation and operation of a screening thermograph intended to be used for non-invasive febrile temperature screening of individuals under indoor environmental conditions to prevent the spread of infection. NOTE The equipment standard for screening thermographs is found in IEC 80601?2-59.