This document provides recommended and other product type names and example pictures of product categories defined in ISO 9999, subclass 09 30, "Absorbing products to contain urine and faeces".

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This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized. This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) initial treatment at the point of use; b) preparation before cleaning; c) cleaning; d) disinfection; e) drying; f) inspection and maintenance; g) packaging; h) sterilization; i) storage; j) transportation. This document excludes processing of the following: —   non-critical medical devices unless they are intended to be sterilized; —   textile devices used in patient draping systems or surgical clothing; —   medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE      See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device.

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This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements. These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.

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This document specifies requirements and test methods of rollators being used as assistive products for walking with wheels, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer including marking and labelling. The requirements and tests are based on every-day use of rollators as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes rollators specified for a user mass of no less than 35Â kg. This document is not applicable to rollators with horizontal forearm supports, classified as walking tables, for which ISOÂ 11199-3 is applicable.

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This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation. This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA). This document does not apply to the post-vasectomy assessments. NOTE      Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).

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This document specifies requirements and their test methods for tissue punches used with a handpiece in dentistry especially for oral surgical implant procedures such as cutting holes or notches in and removing of gingival tissue. It also specifies the requirements for their marking and labelling.

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DOW = DAV+36 months

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This document covers the preanalytical phase and recommends the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis.
The document is applicable to metabolomics examinations and is of importance to biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities. The adoption of the described procedures for the preanalytical phase make it possible to compare and evaluate the results obtained from metabolic profiling analysis.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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This document is applicable to optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision aids. This document specifies requirements and test methods for optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision devices. Implantable low vision devices are excluded.

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This document specifies apparatus, test methods, and disclosure requirements for determination of lateral stability properties of wheelchair seat cushions by measuring the response from the cushion to a shift in the centre of mass of the load on the cushion. It provides a method of determining changes in a particular physical and mechanical property of the cushion. It does not provide information specific to cushion performance for a particular individual user. It does not provide information related to anterior-posterior stability, nor to stability contributions from cushion edges. NOTEÂ 1Â Â Â Test conditions simulate a symmetric anatomy. NOTEÂ 2Â Â Â Loads are intended to represent those seen under the pelvis of a 40th to 60th percentile wheelchair user. This document is applicable to cushions used in situations other than a wheelchair.

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This document gives recommendations for the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated DNA during the pre-examination phase before a molecular examination is performed.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

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This document specifies a method for using high-performance liquid chromatography (HPLC) to determine the presence of aristolochic acid I in natural products.

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This document provides requirements for patient-centred staffing in healthcare settings. It is generic and applicable to any healthcare organization.

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This document specifies requirements and test methods to assess the resistance to ignition by smouldering cigarette equivalent of integrated or non-integrated components of a wheelchair intended to protect tissue integrity and/or provide postural support. The electronic ignition source is also a simulation of other potential sources of environmental ignition hazards. The tests measure only the resistance to ignition of the items tested, and not the ignitability of the complete wheelchair. It gives an indication, but cannot guarantee, the ignition behaviour of the assembled devices of a complete wheelchair. This document does not apply to resistance to ignition of structural parts of a wheelchair. This document does not cover changes in resistance to ignition as a result of regular washing or use of the postural support devices. This document does not apply to the control of risks created by electrical and electronic components. This document allows for the separate testing of components of a wheelchair that are normally used in the horizontal plane (e.g. a seat cushion) from those normally used in the vertical plane (e.g. a back support). This document describes testing an assembly of the composite of materials as used in the component. The results of the tests in this document do not give any indication of the resistance to ignition of any of the separate individual materials of the test sample. NOTEÂ Â Â Â Â The intent of this document is primarily to address components that interface with the human body, such as cushions for positioning, or whose described purpose is that of protecting skin tissue against pressure, shear, and maceration related damage, as well as textile, foam, and plastic-based postural support devices.

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This document specifies the requirements and test methods for endodontic compactors (pluggers and spreaders) which are used for the compaction of endodontic filling materials, and also heat-carriers (which are not specified in the other parts of the ISOÂ 3630 series). This document specifies the requirements for size, marking, product designation, safety considerations, and their labelling and packaging.

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This particular standard applies to basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS), which is a unique application of NIRS in that it employs multiple wavelengths of light energy and time-resolved (frequency or time domain) and/or spatially resolved methods to derive a quantitative measure of tissue oxygen saturation of haemoglobin within the field of the NIRS sensor. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Additional standards may apply to ME EQUIPMENT for those environments of use.
Not included within the scope of this particular standard are:
a) Invasive tissue or vascular oximeters
b) Device measuring dissolved oxygen
c) Functional NIRS device covered by IEC 80601-2-71, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes
d) Pulse oximeter covered by ISO 80601-2-61, where not intended for obtaining cerebral tissue oximeter signals for monitoring purposes; however, manufacturers should consider using relevant clauses of this standard as appropriate for their intended use.
NOTE: a manufacturer may claim monitoring of tissue other than cerebral, which is not covered
by this standard.

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This document specifies requirements and test methods for intraoral cameras used in dentistry on the patient for pictorial representation of the oral cavity in order to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use and marking.
This document is not applicable to
a)   powered polymerization activators for polymerization of dental materials;
b)   exclusively extraoral camera equipment to prepare overviews or to record treatments;
c)   dental microscopes for minimally invasive treatments;
d)   medical endoscopes;
e)   camera handpieces for tooth illumination (transillumination);
f)   CAD/CAM scanner handpieces;
g)   combinations of dental instruments with camera functions;
h)   cameras for endodontic purposes;
i)   devices for root canal inspection (endoscopic microcameras);
j)   cameras for tool navigation;
k)   cameras for determination of tooth colour.

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This document is applicable to pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar or test pressure up to a maximum of 300 bar, or both. NOTE 1   This type of connection is primarily used for small cylinders (5 l or below). NOTE 2   In this document the unit bar is used, due to its universal use in the field of technical gases. It should, however, be noted that bar is not an SI unit, and that the corresponding SI unit for pressure is Pa (1 bar = 105 Pa = 105 N/m2). This document specifies: —   basic dimensions; —   requirements for alternative designs of the yoke-type valve connections; —   dimensions and positions for the holes and pins for the outlet connections. It also specifies the dimensions and positions for the holes and pins for the outlet connections for gases and gas mixtures.

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ISO 80601-2-87 applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment:- intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility; - intended to be operated by a healthcare professional operator;- intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and- capable of providing more than 150 inflations/min. There are three principal designations of HFV:- high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min];- high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and- high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase].

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2020-11-12 - TC decision is missing to skip FV.

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NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical
device or by the manufacturer for 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.

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This document specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this document and thus qualifies as a CT according to this document. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye. NOTEÂ Â Â Â Â The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface. This document is not applicable to ophthalmic instruments classified as ophthalmometers.

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This document specifies requirements and test methods for walking frames used as assistive products for walking, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling. The requirements and tests are based on everyday use of walking frames as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes walking frames specified for a user mass of no less than 35Â kg.

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This document specifies requirements for the mechanical assessment of spinal intervertebral body fusion devices (IBFDs) used in spinal arthrodesis procedures. This document focuses on mechanical requirements and does not intend to cover all assessments for various types of IBFDs.

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This document specifies requirements and test methods for laser acupoint devices. This document is not applicable to carbon-dioxide-type lasers. In the case of combined devices, it is applicable only to the laser features.

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This document specifies requirements and recommendations for the pre-examination phase of human specimens, including saliva, skin, urine and stool, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, storage, processing and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for the pre-examination phase for infectious disease examination (eg. targeted pathogen identification). These are not described in this document.
Different dedicated measures are taken for the pre-examination phase of saliva for human genomic DNA examination. These are not described in this document but are covered in CEN WI00140116, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated DNA.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis model.

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This document specifies the general requirements for instruments to be used in association with nonactive
surgical implants. These requirements apply to instruments when they are manufactured and
when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term “instrument” refers to an instrument for use in
association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it
does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design
attributes, materials, design evaluation, manufacture, sterilization, packaging, and information
supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and
transradicular implants and ophthalmic implants.

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This document establishes a vocabulary of terms and semantics for all fields of respiratory care involving mechanical ventilation, such as intensive-care ventilation, anaesthesia ventilation, emergency and transport ventilation and home-care ventilation, including sleep-apnoea breathing-therapy equipment. It is applicable
— in lung ventilator and breathing-therapy device standards,
— in health informatics standards,
— for labelling on medical electrical equipment and medical electrical systems,
— in medical electrical equipment and medical electrical system instructions for use and accompanying documents,
— for medical electrical equipment and medical electrical systems interoperability, and
— in electronic health records.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator and ventilator breathing system.
NOTE This document can also be used for other applications relating to lung ventilation, including non-electrical devices and equipment, research, description of critical events, forensic analysis and adverse event (vigilance) reporting systems.
This document does not specify terms specific to breathing-therapy equipment, or to physiologic closed-loop ventilation, high-frequency ventilation or negative-pressure ventilation; nor to respiratory support using liquid ventilation or extra-corporeal gas exchange, or oxygen, except where it has been considered necessary to establish boundaries between bordering concepts.

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This document presents guidelines for the design and development of cognitively accessible systems, including products and services and built environments.
This document is relevant to mainstream systems as well as those designed specifically for people with disability.
Within the broad field of accessibility, this document is limited to guidance related to cognitive accessibility.
NOTE 1 It acknowledges, however, that diverse sensory perceptions can impact cognitive accessibility.
NOTE 2 While the following guidance in this document can benefit all users, it is included here because failure to follow it could lead to barriers that would prevent some potential users from being able to use the system at all.
This document is relevant to all types of systems. However, some particular recommendations can only be followed for some types of systems:
— Some of the guidance is relevant to a fixed system (e.g. a non-computerized consumer product or a user manual);
— Some of the guidance applies to systems containing some level of computer-based processing (e.g. a microwave oven or an ICT-system);
— Some of the guidance applies to systems that use advanced computer processing that supports individualization (e.g. an application in a smart phone);
— Some guidance applies to combinations of the above.

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This document specifies the requirements and test methods for external tooth bleaching products.
These products are intended for use in the oral cavity, either by professional application (in-office
tooth bleaching products) or consumer application (professional or non-professional home use of
tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and
manufacturer’s instructions for use.
This document is not applicable to tooth bleaching products:
— specified in ISO 11609;
— intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal)
or using restorative approaches, such as veneers or crowns;
— auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights)
that are used in conjunction with the bleaching products.
This document does not specify biological safety aspects of tooth bleaching products.
NOTE Maximum concentration of a bleaching agent for professional or non-professional use is subject to
each country’s regulatory body.

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This document specifies requirements and gives recommendations for the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis in the pre-examination processes. This document is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.

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This document applies to capsule endoscopes used for clinical practice. The document defines relevant terms and gives requirements for them.

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This document specifies the requirements and their test methods for elastomeric impression and bite
registration materials.
NOTE This document does not address possible biological hazards associated with the materials. Assessment
of these hazards is addressed in ISO 7405 and the ISO 10993 series.

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This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTEÂ Â Â Â Â International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

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This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE 1 See Annex A. NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa. This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]); - infusion system closure piercing connectors (ISO 8536-4 [4]). NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included. NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.

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This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.
This document does not specify requirements for the following small-bore connectors, which are specified in other documents:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [6] referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]);
- infusion system closure piercing connectors (ISO 8536-€‘4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-€‘1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-€‘1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.

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This document specifies requirements and their test methods for tissue punches used with a handpiece in dentistry especially for oral surgical implant procedures, such as cutting holes or notches in and removing of gingival tissue. It also specifies the requirements for their marking and labelling.

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This document specifies requirements and recommendations for healthcare interpreting services in spoken and signed communication. It is applicable to all situations requiring healthcare interpreting, where the parties involved need to communicate using spoken or signed language, to treat a health-related issue. It is intended for interpreting service providers and healthcare interpreters.

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2021-02.09 -JO - positive assessment for MDD (EN IEC 60601-2-83:2020 - PR= 64477) and the comments of the HAS consultant for MDR was resolved by the TC for EN IEC 60601-2-83:2020/prA11 - PR= 72969
This A11 introduces a revised Annex ZA & Annex ZZ  to EN IEC 60601-2-83:2020 in view of offering it for citation in OJEU under MDD (93/42/EEC) and MDR (2017/745)

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