VAZ - Healthcare

This document specifies strategies for risk estimation and evaluation of biological harms with respect to:
genotoxicity;
carcinogenicity;
reproductive toxicity; and
developmental toxicity.
This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established.
This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations.
NOTE            Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.

This document specifies procedures and techniques for obtaining comparable values for the absorptance of optical laser components.

This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations.
This document applies only to the materials used in combination. Conformity cannot be claimed for a single material.
For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

This document specifies requirements for the physical and chemical properties of dentifrices and provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and packaging of dentifrices.
This document is applicable to dentifrices, including toothpastes, destined to be used by consumers on a daily basis with a toothbrush to promote oral hygiene.
This document does not apply to specific qualitative and quantitative requirements for freedom from biological and toxicological hazards. These are covered in ISO 7405 and ISO 10993-1.

This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.
This document applies to portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.
NOTE            Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document.
This document does not apply to stationary dental equipment, wearable equipment (e.g. headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.

This document specifies requirements for reference measurement procedures (RMP) for measurands used in laboratory medicine.
This document applies to:
RMPs providing values of differential or rational quantities where each quantity value is a numerical value multiplied by a measurement unit. Annex A provides information on ordinal quantities and nominal properties;
any person, body or institution developing RMPs for measurands used in laboratory medicine.

This document specifies methods by which the measurement of irradiance (fluence) distribution is made and specifies parameters for the characterization of the spatial properties of laser irradiance (fluence) distribution functions at a given plane.
The methods given in this document are intended to be used for the testing and characterization of both continuous wave (cw) and pulsed laser beams used in optics and optical instruments.
This document provides definitions of terms and symbols to be used in referring to irradiance distribution, as well as requirements for its measurement. For pulsed lasers, the distribution of time-integrated irradiance (i.e. radiant exposure) is the quantity most often measured.

This document defines basic terms, symbols and units of measurement for the field of laser technology in order to unify the terminology, and to arrive at clear definitions and reproducible tests of beam parameters and laser-oriented product properties.
NOTE            The laser hierarchical vocabulary laid down in this document differs from that given in IEC 60825–1. ISO and IEC have discussed this difference and agree that it reflects the different purposes for which the two standards serve. For more details, see informative Annex A.

This document specifies requirements for certified reference materials (CRMs) of higher metrological order and the content of the supporting documentation and the calibration hierarchies as described in ISO 17511:2020, 5.2.1, 5.3.1, 5.4.1, 5.5.1, 5.6.1, 5.7.1. It is applicable to CRMs intended for use as either primary reference materials (PRMs), secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. It also specifies requirements for determining the certified value of a CRM, including evaluation, and reporting of the assigned uncertainty.
This document is applicable primarily to CRMs with assigned property values where the property has a magnitude that can be expressed as a quantitative scalar number or ratio to a reference or refers to a counting scale as also described in ISO 17511:2020, Clause 1.
When a CRM includes multiple measurands, this document is applied to each of the certified quantity values present in the CRM.
Although intended to be applicable to producers of CRMs, this document is also useful for reference materials (RMs) that are not in conformity with the full metrological requirements of CRMs. For example, this document does not apply to an RM created by an in vitro diagnostic medical device (IVD MD) manufacturer for use as working calibrator or end-user calibrator within a calibration hierarchy traceable to a CRM, although some content can be useful in assessing its performance.

This document gives guidance on designating medical devices to cleaning classification categories, attributes used for medical device cleaning classification category, and designation of a cleaning process.
The cleaning classification category is comprised of two parts:
designate medical devices to a product family;
designate product families to cleaning processes.
NOTE 1        This allows grouping of medical devices into cleaning classification categories during cleaning and identification of master products during cleaning validation.
This document is applicable to manufacturers devising cleaning methods and instructions for processing. It also applies to any processing facility where medical devices are cleaned.
This document does not cover processing of single-use medical devices provided as sterile before use and textile devices.
NOTE 2        Manual cleaning steps before automated cleaning do not include steps that are considered point of use treatment that can be specified.
NOTE 3        Microbiocidal processes (sanitization, disinfection, sterilization) are not in the scope of the medical device cleaning classification categories.

This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials.
This document is applicable to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators can be powered by an internal power supply (rechargeable battery powered) or can be powered by external (mains) power or can be powered by a dental unit. Lasers or plasma arc devices are not covered by this document.
This document does not apply to powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

This document specifies optical and non-optical requirements and the test methods for anti-reflective and hydrophobic properties of coatings on spectacle lenses.
This document does not apply to the following topics:
requirements and test methods incorporated in other ISO 8980 series standards;
the colour of the reflected light.

This document specifies a method of testing the laser-induced ignition and damage of medical beam delivery systems to allow checking of suitable products according to the classification system.
NOTE 1 Take care when interpreting these results, since the direct applicability of the results of this test method to the clinical situation has not been fully established.
NOTE 2 Users of products tested by this method are cautioned that the laser will be wavelength sensitive and tested at the wavelength for which it is intended to be used. If tested using other wavelengths, the power settings and modes of beam delivery need to be explicitly stated.
CAUTION — This test method can involve hazardous materials, operations and equipment. This document provides advice on minimizing some of the risks associated with its use but does not purport to address all such risks. It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

1.1       This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE         Although the scope is limited to medical devices, this document can be applicable to other products and equipment.
This document covers radiation processes employing irradiators using:
a)      the radionuclide 60Co or 137Cs;
b)      a beam from an electron generator; or
c)       a beam from an X-ray generator.
1.2       This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE         For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A.
1.2.1       This document does not specify requirements for designating a medical device as sterile.
NOTE         Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2       This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE         It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3       This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4       This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
NOTE         Regulations on safety requirements for occupational safety related to radiation can exist in some countries.
1.2.5       This document does not specify requirements for the sterilization of used or reprocessed devices.

This document provides guidance on risks specific to artificial intelligence (AI) and machine learning (ML) and how to apply the risk management process of ISO 14971 to ML-enabled medical devices (MLMD). This document is intended to be used in conjunction with ISO 14971 and ISO/TR 24971[2].
This document does not apply to MLMD employing large language models (LLM) or generative AI.

This document classifies denture adhesives used by wearers of removable dentures. It also specifies requirements, test methods and instructions to be supplied for the use of such products.
This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.

This document specifies requirements and test methods for measuring the accuracy of electronic apex locators that are used to determine the apex location during endodontic treatment.

This document specifies coupling between handpieces and motors that are connected to dental units. For the purposes of this document, the couplings described in this document are not equipped with electronic terminal(s).
This document specifies the nominal dimensions, tolerances and extraction force of coupling systems for use between handpieces and motor which supply the handpiece with water, air and light and rotation energy.

This document specifies requirements for oropharyngeal airways.
This document is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways.
This document is not applicable to supralaryngeal airways, which are covered by ISO 11712[1].
The requirements that are also applicable to other airway devices have been removed from this document as they now appear in the general airway device standard (ISO 18190).
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190).

This document specifies requirements and test methods for operating lights used in dental treatment and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources and those intended for patient contact, e.g. from dental handpieces and dental headlamps, fibreoptic intraoral operating lights and operating lights which are specifically designed for use in oral surgery.

This document specifies the requirements and methods for the clinical investigation of medical electrical (ME) equipment used to measure the body temperature in indirect measurement mode.
This document covers both intermittently and continuously measuring clinical thermometers.
NOTE 1        This document does not apply to clinical thermometers measuring the body temperature in direct measurement mode.
NOTE 2        For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with ISO 80601-2-56:—1) is considered sufficient.
This document is applicable to clinical thermometers with claimed measurement time shorter than 60 seconds (for methods such as oral or rectal measurement), or shorter than 5 minutes (for methods such as axillary measurement), and which are treated as predictive type thermometers and fall under the scope of this document.
This document specifies additional disclosure requirements.
This document does not apply to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
This document does not apply to pulmonary artery catheter for the determination of cardiac output by thermodilution.
NOTE 3        ISO 80601-2-56:—1) does include pulmonary artery catheter for the determination of cardiac output by thermodilution.

This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient.
This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
—     respiratory;
—     enteral;
—     limb cuff inflation;
—     neural;
—     intravascular or hypodermic;
—     other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE            Clause A.2 contains guidance or rationale for this Clause.

This document specifies requirements for implantation test methods for preclinical assessment of the local effects after implantation of medical devices or materials intended for use in medical devices. This document is applicable to the evaluation of local tissue responses from medical devices that are intended to be used where skin or mucosal tissue is breached, when required.
This document is applicable to medical device or materials that require implantation evaluation and can be solid or non-solid (such as porous materials, liquids, gels, pastes, powders, and particulates), absorbable, degradable, non- absorbable, or can be tissue-engineered medical products (TEMPs).
These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical loading or functional performance. This document also does not provide guidance on methods and study design to satisfy requirements for systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the study designs can be modified to also assess other biological effects.

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
NOTE 1        In some countries, national or regional pharmacopoeias or other government regulations are legally binding, and these requirements take precedence over this document.
NOTE 2        Annex E provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document.
NOTE 3        Annex F provides recommendations regarding sustainability.
NOTE 4        Annex G provides information on attributive and variable testing.

This document specifies allowable limits (AL) for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining conformity so that devices can be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in Annexes A, B, C, D, E, F, G, H, I, J and K.
EO-sterilized devices or components that have neither direct nor indirect body or user contact (e.g. in vitro diagnostic devices) are out of scope of this document. This document does not apply to devices that have been demonstrated to not absorb or retain EO or its degradation product ECH, such as medical devices made exclusively of metal alloys and glass, see Clause C.5[228].
NOTE            This document does not specify limits for ethylene glycol (EG). No device limits are specified for EG because the risk assessment in Annex F indicates that calculated allowable levels are higher than those likely to occur in a medical device.

This document specifies requirements for the respiratory tubing and connectors used to convey respirable gases to a patient in the healthcare and homecare environments and provide a safe connection between the gas supply device and the patient interface. Respiratory tubing and connectors are mainly used for delivery of oxygen but can also be used for respirable air or oxygen/air mixtures and breathable medicinal gas mixtures such as oxygen/nitrous oxide or oxygen/helium mixtures. This document also specifies requirements for respiratory therapy extension tubing.
NOTE 1        The gas supply devices referred to in this document do not include anaesthetic machines/workstations and ventilators.
NOTE 2        This document does not cover breathing tubes for breathing systems. These are specified in ISO 5367.
This document is written following the format of ISO 18190, General standard for airways and related equipment. The requirements in this device-specific standard take precedence over any conflicting requirements in the General standard

This document specifies requirements for the optical and geometrical properties of semi-finished blanks.

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 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

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 anaesthet

This document specifies requirements and test methods for male condoms made from natural rubber latex.
This document does not specify requirements related to any medicinal substances applied to or delivered by the condom.
NOTE            The safety and effectiveness of any medicinal substance are assessed according to national and regional regulations.

This document specifies good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies the general requirements intended to
protect the rights, safety and well-being of human subjects, users or other persons,
ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
define the responsibilities of the sponsor and principal investigator, and
assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s).
NOTE            For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [5]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.

This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination, examination, and post-examination aspects including accurate transmission of examination results into the electronic medical record, as well as other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document complements the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

NOTE 1        There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical device or an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.
Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that can include:
implant body;
implant abutment;
abutment screw;
implant connecting part;
implant connecting part screw;
prosthetic screw;
implant cover screw;
transmucosal healing component.
This document also specifies requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
This document does not apply to the following devices:
dental implants incorporating animal or human components or bioactive characteristics;
custom-made devices that have no pre-fabricated connection;
implantable materials for bone filling and augmentation in oral and maxillofacial surgery;
membrane materials for guided tissue regeneration in oral and maxillofacial surgery;
specific instruments indicated to be used as part of a dental implant system.
NOTE 1        ISO 22794 specifies the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 specifies the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2        ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3        Custom-made devices are defined in IMDRF/PMD WG/N49 [5].

This document contains definitions of terms related to intraocular lenses as well as definitions related to the methods used to evaluate these IOLs.
NOTE            The terms are listed in the alphabetical order of the English terms.

This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD.
The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces).
NOTE            Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two.
This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.

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.

This document specifies requirements for transportable liquid oxygen systems that are common to both base units and portable units and requirements that are particular to base units.
Stationary liquid oxygen systems used for oxygen pipeline supply systems are excluded from this document.
NOTE 1        Throughout this document the term “units” is used where the requirement applies to both base units and portable units.
NOTE 2        ISO 18777 - 2 specifies those requirements particular to portable units.

This document specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging.
NOTE            This document attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there can be additional national requirements.

This document is applicable for evaluating absorbent incontinence products for urine, faeces, or both for adults and children. It provides a context for the procedures described in other International Standards and for published testing procedures. General factors relating to incontinence products and their usage are also addressed.

This document specifies requirements and provides recommendations for the pre-examination process of cell-free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen purification and isolation of cfDNA.
This document does not cover dedicated measures for cytohistological analysis of nucleated cells derived from body fluid, nor measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Dedicated measures for preserving circulating cell-free DNA (ccfDNA) from blood are covered in ISO 20186-3.
This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and organizations performing biomedical research, and regulatory authorities.
NOTE            International, national or regional regulations or requirements can also apply to specific topics covered in this document.