VAZ - Healthcare

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 artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial 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 2        See also 4.2 of the general standard.
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.
–    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
–    ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
–    ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
–    ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
–    high-frequency ventilators[23], which are given in ISO 80601-2-87.
–    respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3      ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
–    user-powered resuscitators, which are given in ISO 10651-4;
–    gas-powered emergency resuscitators, which are given in ISO 10651-5;
–    oxygen therapy constant flow ME equipment; and
–    cuirass or “iron-lung” ventilation equipment.

This document specifies particular requirements for portable units which are part of a transportable liquid oxygen system and used to provide a controlled flow of oxygen for inhalation by the patient in the home-care environment.
Portable units are intended to be used without professional supervision, carried by patients while moving around and during their off-site activities and refilled from a base unit via a transfilling device through the portable unit’s filling port connector.
NOTE            Requirements that are common to both portable units and base units are specified in ISO 18777-1.

This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1        Reference to applicable national regulations and internationally accepted pharmacopeias can be made.
NOTE 2        National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.

This document specifies a common data exchange format (i.e. format of the messages and the dictionary of all the items that compose the message) between the prescribers and the laboratories in the animal health sector.
This document is intended for prescribers (purchasers) and service providers in charge of collecting samples and conducting analyses (including laboratories) who are interested in computerizing and standardizing their data exchanges, particularly in the animal health sector.
This document excludes the code lists that are required for unambiguous data exchange.

This document specifies general requirements and test methods for metallic dental elevators. In addition, it specifies dimensional requirements for specific types of dental elevators such as Warwick James elevators, Cryer elevators, Coupland elevators, Bein elevators and Flohr elevators.

This document specifies the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg·cm−2·week−1 set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.
NOTE   The reference method for articles apart from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection is specified in EN 1811.

This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants.
Six grades of titanium based on tensile strength are listed in Table 2.
NOTE            The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily conform with those specified in this document.

This document defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.
This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use.
Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration.
Clause 7 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.

This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.

This document defines terms used in conjunction with, and the general principles of, test methods for determining the laser-induced damage threshold and for the assurance of optical laser components subjected to laser radiation.

This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. This also specifies packaging and labelling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.
This document does not apply to fast acting topical fluoride products such as fluoride oral rinses.

This document specifies requirements and their test methods for sinus membrane elevators used during the placement of dental implants for sinus floor lifting. It also specifies the requirements for their marking and labelling.

NOTE         Clause A.2 contains guidance or rationale for this clause.
This document specifies requirements for small-bore connectors intended to be used for connections in neural applications.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular standards for specific medical devices or accessories.

This document specifies requirements and test methods for acid-base, dental cements intended for permanent cementation, lining and restoration. This document is not intended to address resin-modified water-based cements. This document is applicable to both hand-mixed and encapsulated cements for mechanical mixing. This document specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, base or liner, restorative material or pit and fissure sealing cement.

This document specifies requirements for electrically heated steam boilers manufactured from stainless steel specifically dedicated for generating steam for sterilizers and disinfectors.
This document covers only steam boilers that are heated by immersion heaters and which have a maximum allowable pressure (PS) of not greater than 6 bar, a maximum volume (V) of 1 000 litres and a product of PS ∙ V not greater than 3 000 bar ∙ l.

This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances.
The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use.
The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal requirement or the manufacturers’ decision.
This document does not cover
—     devices for medication loading and transfer, utilizing a blunt tip design, or
—     invasive products whose intended use is to access small spaces, particularly ear, nose and throat, to perform ophthalmic procedures
because their SIPMs have been found to adversely affect the usability and can increase the risk for patients versus the benefit of the intended use of the device.
This document does not cover solid-core needles used for surgery (e.g. suture needles).

This document specifies specific requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and information supplied by the manufacturer.

This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially Type IV allergenic substances employed and remaining in medical gloves. It also provides information on the extraction medium, the method of extraction and quantitative assay of residual chemicals.
This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.

This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer.
This document is applicable to:
—     all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames;
—     spectacle frames made with additive manufacturing, for example, 3D printing;
—     spectacle frames made from natural organic materials;
—     the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply;
—     prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask.
Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1.
NOTE            See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames.
This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.

This document specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This document applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This document does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE   Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665.
This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

This document specifies requirements for fire activated oxygen shut-off devices that stop the flow of oxygen in respiratory therapy tubing when activated by fire.
NOTE 1        Typical arrangements for fire activated oxygen shut-off devices are shown in Annex C.
NOTE 2        Respiratory therapy tubing is covered by ISO 17256.
NOTE 3        Use of fire activated oxygen shut-off devices in medical devices or accessories is not mandated in this document.
The fire activated oxygen shut-off devices specified in this document are not suitable for use with oxygen therapy systems with flows in excess of 20 l/min).
NOTE 4        There is rationale for this clause in A.2.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

1.1        This document specifies requirements relating to the construction and operation of devices producing air through the blending of oxygen and nitrogen for use as sources of supply in supply systems for medical gases.
1.2        This document is applicable to proportioning units intended to produce synthetic medical air and air for driving surgical tools by mixing in defined proportions oxygen and nitrogen.
1.3        This document is applicable to proportioning units intended to be components of a medical gas supply system for medical air which supplies a medical gas pipeline distribution system complying with ISO 7396-1.
1.4        The number of proportioning units within the medical air supply system and their combination with other sources of supply (e.g. cylinder manifolds) to ensure that the supply system consists of at least three sources of supply is outside the scope of this document.
Requirements for the supply systems for medical air are given in ISO 7396-1.

This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.
NOTE 1        This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document.
NOTE 2        For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).

This document specifies the requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. This document also contains specifications on manufacturers’ instructions, marking and packaging.

This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

This document specifies physical and chemical requirements and test methods for oral rinses. It also specifies requirements on the accompanying information to be given in the manufacturer's instructions for use and on containers as well as the requirements for packaging. Common labelling aspects are specified in order to enhance international understanding and trade.
This document is not applicable to other delivery systems (e.g. mouth sprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
This document is not applicable to oral rinses available by prescription only.

This document specifies polymers commonly used in manufacturing dental instruments.
It is applicable to polymers used to manufacture either an entire instrument or part of an instrument.
It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not.
This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers.
This document contains a selection of polymers suitable for use in the manufacture of dental instruments.

This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.

This document specifies test methods for determining the radiant power and radiant energy of continuous wave and pulsed laser beams, as well as their temporal characteristics of pulse shape, pulse duration and pulse repetition rate. Test and evaluation methods are also given for the radiant power stability of cw-lasers, radiant energy stability of pulsed lasers and pulse duration stability.
The test methods given in this document are used for the testing and characterization of lasers.

This document specifies fundamental requirements for uncut finished spectacle lenses. This document is not applicable to protective spectacle lenses.
This document takes precedence over the corresponding requirements of other standards, if differences exist.

This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off which is relevant to the verification of performance requirements such as strength, durability and service life.
This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading.
In addition, this document specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features (see NOTE), by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.
These loading conditions are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle.
The test loading conditions specified in this document are characterized by standardized formats of these loading and locomotion profiles, applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.
This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to the intended use. According to the concept of the tests of this document, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load.
This document is suitable for the assessment and testing of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2016, need not be retested to this document.
NOTE            The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4 (R4) specified in this document approach those determining the sagittal plane loading of the test loading conditions I and II for the principal structural tests referring to ISO 10328:2016, without changing the values of the angles of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328:2016.

This document specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use.
There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this document applies are:
—     a battery;
—     a motor;
—     a mechanical or magnetic drive system;
—     a moving brush head with tufted filaments.
Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-by-side), frequencies and velocities.
These types of electric toothbrushes are tested for safety in use by means of appropriate test procedures or clinical studies
The requirements listed in this document apply to all types of powered toothbrushes. However, there is a possibility that some requirements are not applicable for all types. For example, brush head plate retention can only be applied if the brush has a head portion that can detach from the brush shaft. In addition, for the filaments end-rounding requirements, this document does not apply to filament types that are very thin (less than 0,1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips or spherical cap) or non-synthetic filaments, where applying the end-rounding process is inappropriate or impossible.
This document is not applicable to other types of powered oral hygiene devices (such as powered interdental brushes) or manual toothbrushes.

This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as:
a)       bed frames;
b)       bedside tables;
c)        transport carts;
d)       containers;
e)       surgical tables;
f)         sterilization containers;
g)       surgical clogs;
h)       wheelchairs;
i)         aids for persons with disabilities.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs.
NOTE 1        WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2        The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.

This document defines the requirements for developing and documenting the goals, limitations, target end users and target patient population for artificial intelligence (AI) and augmented intelligence (AuI) enabled 2D radiograph analysis software for dentistry applications. It outlines the requirements for appropriate training data, validation data, test data and annotation for the software to ensure that it achieves its intended goals, and is restricted to the aspects. This document does not cover the specific implementation details, and focuses on static (i.e. non-dynamic) AI/AuI.

This document specifies requirements, recommendations, and guidance on aspects of accessible systems for living independently (ASLI) in relation to technical solutions, service design, provision, and information. This includes adapting design and functionality of systems, to allow ease of use by any user, regardless of their abilities.
This document does not cover system-to-system communication.
This document is not applicable to household and similar electrical appliances covered by EN IEC 63008 [10].

This document specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as single-use sterile barrier systems and/or single-use packaging systems for terminally sterilized medical devices by the means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

This document specifies test methods and values for paper used in the manufacture of single-use preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of low temperature sterilization processes.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

This document specifies test methods and values for single-use paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

This document provides an opinion on the application of the classification rules in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as they pertain to dental devices and accessories.

This document specifies test methods and values for paper used in the manufacture of single-use paper bags (specified in EN 868-4 [3]) and in the manufacture of single-use pouches and reels (specified in EN 868-5 [4]) used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of sterilization processes that require properties specific to higher temperature sterilization, such as moist heat sterilization used in healthcare facilities.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [1], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

This document specifies test methods and values for sterilization wrap made of
-   single-use creped paper
-   single-use nonwoven materials
-   reusable woven textile materials
used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices.
Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

1.1   This document specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
1.2   This document specifies minimum requirements:
-   for the performance and design of sterilizers intended to deliver an LTSF process capable of sterilizing medical devices;
-   for the equipment and controls of these sterilizers which are needed for operation, control and monitoring of the sterilization processes, and which can be used for validation of the sterilization process.
1.3   This document specifies further test equipment and test procedures used to verify conformance of the equipment design and performance specified by this document.
1.4   This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.

This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle.
NOTE            Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.