This document specifies general requirements for ORGANIZATIONS in the application of RISK MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY whilst engaging appropriate stakeholders.

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This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 4-vanadium alloy (Ti-6Al-4V alloy) for use in the manufacture of surgical implants. NOTEÂ Â Â Â Â The mechanical properties of a sample obtained from a finished product made of this alloy might not necessarily comply with the specifications given in this document.

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This document specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices. It is applicable across a wide range of moxibustion devices that use moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage. This document does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.

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This document specifies general requirements for medical suction equipment that are common to all parts of the 10079 series.
The ISO 10079 series does not apply to the following:
a)   end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b)   syringes;
c)   dental suction equipment;
d)   anaesthetic gas scavenging systems;
e)   laboratory suction;
f)   autotransfusion systems;
g)   mucus extractors including neonatal mucus extractors;
h)   suction equipment where the collection container is downstream of the vacuum pump;
i)   ventouse (obstetric) equipment;
j)   suction equipment marked for endoscopic use only
k)   plume evacuation systems.

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This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.
With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

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This document specifies the appropriate application of ISOÂ 17327-1:2018 to coated endovascular prostheses, vascular stents, and vena cava filters. This document is intended to be used as a supplement to ISOÂ 25539-1, ISOÂ 25539-2, ISOÂ 25539-3, ISOÂ 12417-1 and ISO/TSÂ 17137. The following coatings are within the scope of ISOÂ 17327-1 and addressed in this document for endovascular devices: drug coatings (eluting and non-eluting), non-drug coatings (absorbable and non-absorbable), and chemistry-related surface modifications (oxide, such as TiO2, and non-oxide, such as amorphous silicon carbide and diamond-like carbon). This document is not applicable to coated delivery systems or coated ancillary devices (e.g. guidewires), as these coatings are not within the scope of ISOÂ 17327-1, which is specifically directed to implant coatings. This document is not applicable to coverings of endovascular devices; however, if the covering of a device is coated, it is within the scope of this document. This document does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used as implant coatings.

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IEC 62563-2:2021 establishes the performance CRITERIA and test frequencies for the ACCEPTANCE TESTS and CONSTANCY TESTS. The evaluation methods are defined in IEC 62563-1. The scope of this document is directed to practical tests that can be visually evaluated or measured using basic test equipment. This document applies to medical IMAGE DISPLAY SYSTEMS, which can display monochrome image information in the form of greyscale values on colour and greyscale IMAGE DISPLAY SYSTEMS. This document does not apply to information displays and to displays used solely for control of technical settings of all medical information.

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MINOR REVISION
ISO missed to notify CCMC - deadline extended for 1 week.

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This document applies to the basic safety and essential performance of ventilatory high-flow therapy equipment, as defined in 201.3.204, hereafter also referred to as ME equipment, in combination with its accessories:
- intended for use in the home healthcare environment;
- intended for use in professional healthcare facilities;
- intended for use by a lay operator or a healthcare professional operator;
- intended for use with patients who can breathe spontaneously;
- intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, including a patient whose upper airway is bypassed; and
EXAMPLE 1 Patients with Type 1 Respiratory Failure, which exhibits a reduction in arterial blood oxygenation or patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high.
- not intended for patients who are dependent on artificial ventilation for their life support.
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
Ventilatory high-flow therapy equipment is typically composed of four parts:
1) gas sources,
- air, and
- if needed, oxygen;
NOTE 2 Gas sources include medical gas pipeline systems, gas cylinders, oxygen concentrators and ambient air.
2) humidifier;
NOTE 3 When dry gas is utilized, a humidifier is typically needed.
3) breathing tube;
4) a patient interface, which is used to deliver gas to the patient; and
5) a flow controller, which is used to select and deliver the desired flow.
NOTE 4 The flow controller can be at a fixed rate.
NOTE 5 The flowrate range is dependent upon the intended patient population (e.g., neonatal, paediatric and adult patients can require different flowrates).
These parts can be combined (e.g., the gas source and humidifier can be combined). Ventilatory highflow therapy equipment interfaces with the patient whose upper airway is intact via a nasal cannula or mask as well as a patient whose upper airway is bypassed via an endotracheal tube, oropharyngeal mask, or tracheostomy.
Ventilatory 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 ventilatory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory high-flow therapy equipment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
This document does not specify the requirements for:
- ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601 2 12;
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601 2 13;
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601 2 84;
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601 2 72;
- ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601 2 79;
- ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601 2 80;
- sleep apnoea therapy ME equipment, which are given in ISO 80601 2 70;
- continuous positive airway pressure (CPAP) ME equipment;
- high-frequency jet ventilators (HFJVs);
- high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601 2 87; and
- cuirass or "iron-lung" ventilation equipment.
NOTE 4 Ventilatory high-flow therapy equipment can be incorporated into any of the above equipment, in which case those standards would be applicable for those ventilation-modes.
This docum.....

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2021-08-09: following BT decision 131/2021, to be published with Annex ZA and ZB for MDR (EU) 2017/745 and the IVDR (EU) 2017/746 even if negative assessment (SV)
2021-07-14 - Lack of compliance - publication on hold.

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This document specifies the basic terminology of pulse diagnostic methods, the key elements of pulse and pulse condition. Each term of pulse diagnosis includes the English name, the classical Chinese characters and its definition.

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This document specifies the basic terminology and classification of tongue diagnostic methods. Each term of tongue diagnosis includes the English name, the classical Chinese characters and its definition. The classification structure of tongue diagnosis terms is shown in Figure 1.

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2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant

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IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.

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This document specifies general requirements for plasma-sprayed titanium coatings on metallic surgical implants. This document applies to atmospheric plasma spraying and vacuum plasma spraying. This document does not apply to coatings made of other materials than titanium or titanium-6 aluminum-4 vanadium alloy or to coatings realized by another technology than plasma spraying. NOTEÂ Â Â Â Â Â A quality management system can be useful, e.g. as described in ISOÂ 13485. Requirements for the competence of testing laboratories can be found in ISO/IECÂ 17025.

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

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

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This document establishes design evaluation requirements and recommendations for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is intended to supplement device-specific standards by providing guidelines specific for either absorbable implants or components, or both. This document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This document does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non-viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of this document if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant can incorporate substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the implant and supports the primary mode of action of the implant. NOTE 1   Some aspects of absorbable components of cardiovascular device-drug combination products (e.g. coatings) in their connection with drug-related aspects of the device are addressed in ISO 12417-1. NOTE 2   An explanation of the nomenclature of absorb, degrade and related terms can be found in Annex A.

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This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, 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 can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities.
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
Respiratory high-flow therapy equipment can be:
- fully integrated ME equipment; or
- a combination of separate items forming a ME system.
This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode.
NOTE 2 This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator 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.
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 3 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[14];
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[15];
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[20];
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72[17];
- ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79[18];
- ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601‑2‑80[19];
- sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[16];
- continuous positive airway pressure (CPAP) ME equipment;
- high-frequency jet ventilators (HFJVs)[31], which are given in ISO 80601‑2‑87[21];
- gas mixers for medical use, which are given in ISO 11195[9];
- flowmeters, which are given in ISO 15002[11];
- high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[21]; and
- cuirass or “iron-lung” venti

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This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, 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 can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities. NOTE 1       In the home healthcare environment, the supply mains is often not reliable. Respiratory high-flow therapy equipment can be: —  fully integrated ME equipment; or —  a combination of separate items forming a ME system. This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2 This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator 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. 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 3       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[14]; —   ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[15]; —   ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[20]; —   ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72[17]; —   ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79[18]; —   ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601‑2‑80[19]; —   sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[16]; —   continuous positive airway pressure (CPAP) ME equipment; —   high-frequency jet ventilators (HFJVs)[31], which are given in ISO 80601‑2‑87[21]; —   gas mixers for medical use, which are given in

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This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series. This document is not applicable to the following: a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; b) syringes; c) dental suction equipment; d) anaesthetic gas scavenging systems; e) laboratory suction; f) autotransfusion systems; g) mucus extractors including neonatal mucus extractors; h) suction equipment where the collection container is downstream of the vacuum pump; i) ventouse (obstetric) equipment; j) suction equipment marked for endoscopic use only; and k) plume evacuation systems.

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This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON
ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for
TREATMENT of PATIENTS.
NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times
in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the
requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE
and not some other ME EQUIPMENT that may be part of the system configuration.
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the
manufacture and some installation aspects of ELECTRON ACCELERATORS and their included
equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT
delivery
– intended for RADIOTHERAPY in medical practice, including those in which the selection and
DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE
ELECTRONIC SUBSYSTEMS (PESS),
– that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION
or ELECTRON RADIATION having
• NOMINAL ENERGY in the range 1 MeV to 50 MeV,
• maximum ABSORBED DOSE RATES between 0,001 Gy × s–1 and 1 Gy × s–1 at the ERP from
the RADIATION SOURCE, and
• REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION
SOURCE;
and
– intended to be
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by
QUALIFIED PERSONS appropriately licensed or having the required skills for a particular
medical application, for particular SPECIFIED clinical purposes,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
and
• subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED
PERSON.

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This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
INCUBATORS, as defined in 201.3.209, also referred to as ME 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 7.2.13 and 8.4.1 of the general standard.

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2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) , 90/385/EEC (AIMD) and M/295

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ISO 80601-2-74 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). 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.EXAMPLE 2 Heated humidifier incorporated into a critical care ventilator where ISO 80601-2-12[10] also applies. EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601-2-72[12] also applies. EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601-2-70[11] also applies. EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79[13] or ISO 80601-2-80[14] also apply. EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601-2-90[15] 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. 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.

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EN-IEC 60601-2-21 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME 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 7.2.13 and 8.4.1 of the general standard.

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EN-IEC 60601-2-50 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT PHOTOTHERAPY EQUIPMENT, as defined in 201.3.203, also referred to as ME 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 7.2.13 and 8.4.1 of the general standard. This particular standard specifies safety requirements for INFANT PHOTOTHERAPY EQUIPMENT,but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

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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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This part of ISO 10651 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators (3.10) intended for use with humans by first responders. This equipment is intended for emergency field use and is intended to be continuously operator attended in normal use.
This part of ISO 10651 also specifies the requirements for resuscitator sets (3.22).
This part of ISO 10651 is not applicable to electrically-powered resuscitators.
NOTE ISO 10651-3 covers emergency and transport ventilators.

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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 performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses. NOTEÂ Â Â Â Â There is guidance or rationale for this list item contained in A.2.

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This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques. This standard does not apply to: —   introducers (e.g., guidewires) as addressed in ISO 11070, —   isolated organ perfusion cannulae, and —   intravascular catheters as addressed in ISO 10555-3.

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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.
NOTE 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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2019-05-29 IP: Link to legislation (MDD) removed following CLC/TC 62 decision 02/2019 decision (May 2019 plenary)

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2019-05-29 IP: Link to legislation (MDD) removed following CLC/TC 62 decision 02/2019 decision (May 2019 plenary)

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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 1 Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601-1.
NOTE 2 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 3 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[10] also applies.
EXAMPLE 3 Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601-2-72[12] also applies.
EXAMPLE 4 Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601-2-70[11] also applies.
EXAMPLE 5 Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79[13] or ISO 80601-2-80[14] also apply.
EXAMPLE 6 Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601-2-90[15] 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 4 ISO 9360-1 and ISO 9360-2[4] specify safety and performance requirements for a passive HME.
NOTE 5 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 6 Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789[6].
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.
This document is not applicable to nebulizers used for the delivery of a drug to patients.
NOTE 7 ISO 27427[7] specifies the safety and performance requirements for nebulizers.

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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 1       Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1. NOTE 2       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 3       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[10] also applies. EXAMPLE 3        Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2-72[12] also applies. EXAMPLE 4        Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70[11] also applies. EXAMPLE 5        Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79[13] or ISO 80601-2-80[14] also apply. EXAMPLE 6        Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90[15] 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 4       ISO 9360‑1 and ISO 9360‑2[4] specify safety and performance requirements for a passive HME. NOTE 5       If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 6       Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789[6]. 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. This document is not applicable to nebulizers used for the delivery of a drug to patients. NOTE 7             ISO 27427[7] specifies the safety and performance requirements for nebulizers.

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

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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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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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