Source for standards, engineering specifications, manuals and technical publications

This document specifies a method for the selective enumeration of bifidobacteria in milk products by using a colony-count technique at 37 °C under anaerobic conditions.
The method is applicable to milk products, such as fermented (e.g. yoghurts) and non-fermented milks (e.g. pasteurized milks, skim milks, whey protein concentrates), milk powders and formulae (e.g. infant formulae, follow-up formulae for older infants, products for young children) where these microorganisms are present and viable, in combination with other lactic acid bacteria or alone. The method is also applicable to starter and probiotic cultures. For proposed quality criteria of dairy products, see, for example, CXS 243-2003.
Bifidobacteria used in milk products usually belong to the following species (e.g. References [7] and [10]):
—     Bifidobacterium adolescentis;
—     B. animalis subsp. animalis;
—     B. animalis subsp. lactis;
—     B. bifidum;
—     B. breve;
—     B. longum subsp. infantis;
—     B. longum subsp. longum.

This document specifies a method for the measurement of focal spot sizes within the range of 5 µm to 300 µm of X-ray systems up to and including 225 kV tube voltage. This determination is based on the evaluation of an image with a dedicated focal spot that has been radiographically recorded using an edge and evaluated with a digital method.
The imaging quality and the resolution of X-ray images depend highly on the characteristics of the effective focal spot, in particular its size and the two-dimensional intensity distribution as seen from the detector plane.
For the characterization of commercial X-ray tube types (i.e. for advertising or trade), the nominal values of Annex A are preferred.
NOTE            The same procedure can be used at higher kilovoltages by agreement but the accuracy of the measurement can be poorer.

This document specifies a method for determining the Charpy impact strength of plastics under defined conditions. It defines a number of different types of specimen and test configurations. It also specifies different test parameters according to the type of material, the type of test specimen and the type of notch.
The method described in this document can be used to investigate the behaviour of specified types of specimen under the impact conditions defined and for estimating the brittleness or toughness of specimens within the limitations inherent in the test conditions. It can also be used for the determination of comparative data from similar types of material.

This document defines terms and definitions used in the process chain for computer-aided design and computer-aided manufacturing (CAD/CAM) systems in dentistry.
NOTE: See Annex A for a flow chart of the process chain.

IEC 62541-22:2025 specifies an OPC UA Information Model for a basic set of network related components used in other Information Models.
The initial version of this document defines parameter sets for TSN Talkers and Listeners as well as network interfaces and ports as shown in Figure 1. A future version of this document is expected to have a broader scope of other network technologies than Ethernet only.

IEC 62541-14:2026 defines the PubSub communication model. It defines an OPC UA publish subscribe pattern which complements the client server pattern defined by the Services in IEC 62541-4. See IEC 62541-1 for an overview of the two models and their distinct uses.
PubSub allows the distribution of data and events from an OPC UA information source to interested observers inside a device network as well as in IT and analytics cloud systems.
This document consists of
• a general introduction of the PubSub concepts,
• a definition of the PubSub configuration parameters,
• mapping of PubSub concepts and configuration parameters to messages and transport protocols,
• and a PubSub configuration model.
This second edition cancels and replaces the first edition published in 2020. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) Addition of a “Quantity Model” which can be referenced from EngineeringUnit Properties. The model defines quantities and assigned units. In addition it provides alternative units and the conversion to them.
b) Addion of rules for ValuePrecision Property:
• can also be used for other subtypes like Duration and Decimal.
• rules have been added when ValuePrecision has negative values.

This document specifies performance and safety requirements for constant wear suits and suit systems for professional and leisure activities to protect the user against the effects of cold-water immersion, by reducing cold shock and delaying the onset of hypothermia. If a suit system includes a personal flotation device (PFD), it provides protection against drowning. This document is applicable to dry and wet constant wear suits and suit systems. This document does not apply to abandonment suits. Requirements for abandonment suits are given in ISO 15027-2:2026. Test methods for immersion suits are given in ISO 15027-3:2026.

IEC 62132-8:2026 specifies a method for measuring the immunity of an integrated circuit (IC) to radio frequency (RF) radiated electromagnetic disturbances using an IC stripline.
This edition includes the following significant technical changes with respect to the previous edition:
a) frequency range of 150 kHz to 3 GHz was deleted from the scope;
b) extension of upper usable frequency to 6 GHz or higher as long as the defined requirements are fulfilled.
This part of IEC 62132 is to be read in conjunction with IEC 62132-1.

This document gives an overview and provides guidance on the main methods available to quantify the exchanges of greenhouse gases (CO2, N2O, CH4) and ammonia (NH3) between soils and the atmosphere. It is intended to help users to select the measurement method or methods most suited to their purposes by setting out information on the application domain and the main advantages and limitations of each methods.

This document specifies data objects and encoding rules of generic eID-Systems in terms of building blocks for mobile document system infrastructures, and standardizes generic data models for data exchanges between mdoc apps and verification applications. This document is applicable to entities involved in specifying, architecting, designing, testing, maintaining, administering, and operating a mobile eID-System in parts or as a whole.

This part of IEC 61400 specifies a method to calculate the design reliability of wind turbines gearboxes covered by IEC 61400‑4, based upon failure modes where standardized calculation methods are publicly available. Currently, not all failure mechanisms that occur in the field have accepted theoretical models. Therefore, the method only provides a quantitative assessment method of the failure mechanisms that can be described with accepted mathematical models for the complete gearbox, stages (functional units), field replaceable units, and individual components. For the calculable failure mechanisms, it is possible to compare the reliability between different gearbox designs within the limitations of the theoretical models. The use of field-based statistical parameters can improve the accuracy of the calculated reliability. The calculated design reliability can provide information for the lifecycle management strategy. However, this document does not provide trade-off decisions between higher design reliability and maintenance strategies (e.g. preventive or predictive maintenance). This document does not consider repairable system analysis. Due to the lack of accepted theoretical models for some failure modes, the model can currently not predict the apparent failure probability in the field. Neither this document nor IEC 61400-4 specify a minimum value of design reliability.

This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system. This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier. EXAMPLE 1 Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers). NOTE 2 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1. NOTE 3 ISO 5367 specifies other safety and performance requirements for breathing tubes. This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients. NOTE 4 A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier. EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12 also applies. EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2‑72 also applies. EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70 also applies. EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79 or ISO 80601-2-80 also apply. EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90 also applies. This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture. NOTE 5 ISO 9360‑1 and ISO 9360‑2 specify safety and performance requirements for a passive HME. NOTE 6 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 7 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789. This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators to humidify the chamber air (i.e., are not directly connected to the patient). This document is not applicable to nebulizers used for the delivery of a drug to patients. NOTE 8 ISO 27427 specifies the safety and performance requirements for nebulizers.

This part of IEC 62541 belongs to the OPC Unified Architecture standards series and defines the Information Model associated with Historical Access (HA). It particularly includes additional and complementary descriptions of the NodeClasses and Attributes needed for Historical Access, additional standard Properties, and other information and behaviour.
The complete AddressSpace Model including all NodeClasses and Attributes is specified in IEC 62541-3. The predefined Information Model is defined in IEC 62541-5. The Services to detect and access historical data and events, and description of the ExtensibleParameter types are specified in IEC 62541-4.
This document includes functionality to compute and return Aggregates like minimum, maximum, average etc. The Information Model and the concrete working of Aggregates are defined in IEC 62541-13.
Conventions for Historical Access Clients are informatively provided in Annex A.

IEC 63350:2026 specifies generic requirements for creating a digital system that is used for measuring the characteristics of visually detectable performance, such as browning intensity and lightness.
It defines the metrological requirements of this digital system and demonstrates the procedures for compliance. The digital system contains the measuring instrument, the software, and the reference materials necessary to realize the measurement process.
References to this document can be made by a customer when specifying the digital system and by the suppliers when specifying products offered.
Interested parties can agree to use this document as an input for satisfying measurement management system requirements in any activities.
This first edition cancels and replaces IEC TS 63350, published in 2022.
This edition includes the following significant technical changes with respect to IEC TS 63350:
a) Revision of 4.2: movable items (e.g., containers, jigs, reference objects) can now be present in the assessment area provided that mitigation measures are applied and periodic verification against known reference artefacts is documented; the requirement to keep the assessment area as constant as possible is retained.
b) Addition of new supporting document: Note in 5.1 introduces the Fogra 52 profile (included in the reference colour supporting documents from the IEC SC 59K supporting documents web site) which is referencing the conditions ISO 12647-7 and ISO 12647-2.
c) Four additional reference shades with hue angles > 130° are introduced in 5.3 for calibration (to enable accurate pixel‑wise hue‑angle measurement). These do not create new shade classes.
d) Revision of 6.2: Calculation of sampling positions remains unchanged, but the procedure changes to reflect better the actual test scenario.
e) Added reporting of input image colour channel data (7.7).

This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in ‎201.3.262, hereafter also referred to as ME equipment or ME system, in combination with its accessories: intended for use with patients who can breathe spontaneously; and intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment is utilized in both professional healthcare facilities and the home healthcare environment. This standard specifically addresses respiratory high-flow therapy equipment for acute or infant care, predominantly found in hospitals. A separate document for long term high-flow therapy in the home healthcare environment is expected to be forthcoming. Respiratory high-flow therapy equipment can be: fully integrated ME equipment; or a combination of separate items forming a ME system. This document also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2 This document and ISO 80601-2-12 are applicable to a critical care ventilator with a high-flow therapy mode. NOTE 3 This document and ISO 80601-2-72 are applicable to ventilator for ventilator-dependent patients in the home healthcare environment with a high-flow therapy mode. NOTE 4 This document and ISO 80601-2-13 are applicable to an anaesthetic workstation with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway. NOTE 5 Accessories are assessed with the relevant clauses of this document when configured as part of respiratory high-flow therapy equipment. 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 the general standard, 7.2.13 and 8.4.1. NOTE 6 Additional information can be found in the general standard, 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; ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84; 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 patients with ventilatory impairment, which are given in ISO 80601‑2‑79; ventilatory support equipment or accessories intende

This document defines the term nonwovens and provides auxiliary terminology to distinguish nonwovens from other materials.

This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products). The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment. 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 says 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 201.11.1.2.2, IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 2 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability. This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. This document is not applicable to pulse oximeter equipment intended solely for foetal use. This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 3 ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function. This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use. This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.

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 specifies building blocks for the implementation of the operational phase of mobile eID systems and any other mdoc for national bodies or document-specific standards to create profiles according to their needs. This document specifies the interface between the mdoc app and mdoc reader and the interface between the mdoc reader and the issuing authority infrastructure. More specifically, this document defines transport protocols for various RF solutions and for over the internet. It defines the application layers, such as the request-response protocols between an mdoc app and mdoc reader and between an mdoc reader and issuing authority. It further defines the security mechanism for issuer authentication, mdoc authentication and credential holder verification. This document also specifies mechanisms enabling parties other than the issuing authority to: use a machine to obtain the mdoc data; bind the mdoc to the mdoc holder; authenticate the origin of the mdoc data; verify the integrity of the mdoc data. The following items are out of scope for this document: provisioning of the mdoc data (this is covered by ISO/IEC TS 23220-3); how holder’s consent to share data is obtained; requirements on storage of mdoc data and mdoc private keys. Finally, it provides information to create a conformant profile.

This document specifies a method for the determination of fatty acid methyl esters (FAMEs) derived by transesterification or esterification from fats, oils, and fatty acids by capillary gas chromatography (GLC). FAMEs from C4 to C24 can be separated using this document including saturated FAMEs, cis- and trans-monounsaturated FAMEs, and cis- and trans-polyunsaturated FAMEs.
This document is applicable to crude, refined, partially hydrogenated or fully hydrogenated fats, oils and fatty acids derived from animal and vegetable sources, and fats extracted from foodstuff.
This document does not apply to milk and milk products (or fat coming from milk and milk products) or products supplemented with conjugated linoleic acid (CLA).
This document does not apply to di-, tri-, polymerized, hydroxylated and oxidized fatty acids, and fats and oils.
A method for the determination of the composition of FAMEs expressed by area % in liquid vegetable oils is proposed in Annex E.