Zdraví, životní prostředí a zdravotní zařízení

Oblast zaměření: Sterilizace zařízení
Komise : CEN/TC 102 (Sterilizers and associated equipment for processing of medical devices)
Původce: CEN
K připomínkám do: 28.11.2020
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1.1  This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7 day reference incubation time specified in 7.3.22 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.

1.2  This document is applicable to manufacturers of biological indicators and to end users of biological indicators who intend to, if required by their quality system, establish, validate or confirm an RIT.

1.3  This document is not applicable to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.

NOTE 1 The method described in this document to establish an RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish an RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.

NOTE 2 For EO as a sterilizing agent, the stated RIT will be applicable for any EO cycle type, i.e. 100% EO, EO blends, etc.

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 30.11.2020
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Replacement:

This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.219, hereafter also referred to as ME equipment, 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, including a patient whose upper airway is bypassed.

EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit 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.

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 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 2         Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.

If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012, 7.2.13 and 8.4.1.

NOTE 2       Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 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[15];

—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[16];

—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[19][1];

—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72[18];

—    ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79[19];

—    ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601‑2‑80[20];

—    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)[30], which are given in ISO 80601‑2‑87[20];

—    gas mixers for medical use, which are given in ISO 11195[11];

—    high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[20]; and

—    cuirass or “iron-lung” ventilation equipment.

NOTE 3       Respiratory 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 document is a particular standard in the IEC 60601 and IEC/ISO 80601 series of documents.

 

[1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 5.12.2020
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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 6-AI4-V alloy) for use in the manufacture of surgical implants.

NOTE       The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with the specifications given in this part of ISO 5832.

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 7.12.2020
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This document specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this document.

This document also specifies terms and definitions which are used in European Standards.

It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages).

It is intended to:

a)     enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product;

b)    enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product;

c)     assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market.

It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas.

In the area of human medicine (Working Group 1, i.e. WG 1), it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care

—    in hospitals, in community medical facilities, dental institutions and medical laboratories for analyses and research,

—    in clinics of schools, of kindergartens and of nursing homes,

—    and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient.

In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals and veterinary laboratories for analyses and research. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry.

In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, laboratories (except laboratories for veterinary and medical analyses and research), pharmaceutical, cosmetic etc. industries.

This document is also applicable to active substances and products under development for which no area of application has yet been specified.

This document will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards should be used, even if they are not yet mentioned in EN 14885.

This document does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.

Oblast zaměření: Ergonomie
Komise : CEN/TC 122 (Ergonomics)
Původce: CEN
K připomínkám do: 7.12.2020
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This document can be used to compare the performance of different ensembles as part of any PPE selection process.

This document does not replace the product standards for the certification of individual items of PPE. It specifies the testing of individual items of PPE as an ensemble, so that the interaction between the individual items of PPE can be evaluated and any adverse interactions between the individual items of PPE can be identified.

It specifies requirements for testing by either assessing the performance of a PPE ensemble against a benchmark condition (i.e. benchmark testing) or assessing the performance of two or more PPE ensembles against each other (i.e. comparative testing).

The standard incorporates laboratory as well as field based testing. It can also be used to assess the performance regarding the ergonomics of an ensemble that incorporates an item of PPE that has never before been incorporated into an ensemble.

Oblast zaměření: Ergonomie
Komise : CEN/TC 122 (Ergonomics)
Původce: CEN
K připomínkám do: 18.12.2020
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The metabolic rate, as a conversion of chemical into mechanical and thermal energy, measures the energetic cost of muscular load and gives a quantitative estimate of the activity. Metabolic rate is an important determinant of the comfort or the strain resulting from exposure to a thermal environment. In particular, in hot climates, the high levels of metabolic heat production associated with muscular work aggravate heat stress, as large amounts of heat need to be dissipated, mostly by sweat evaporation. On the contrary, in cold environments, high levels of metabolic heat production help to compensate for excessive heat losses through the skin and therefore reduce the cold strain.

This International Standard specifies different methods for the evaluation of metabolic rate in the context of ergonomics of the thermal working environment. It can also be used for other applications — for example, the assessment of working practices, energetic cost of specific jobs or sport activities, the total energy cost of an activity, etc.

The estimations, tables and other data included in this International Standard concern the general working population. Users should make appropriate corrections when they are dealing with special populations including children, aged persons, people with physical disabilities, etc. Personal characteristics, e.g. body mass, may be used if the body is moved due to walking or climbing (Annex A and B). Gender, age and body mass are considered in Annex C for the evaluation of the metabolic rate from heart rate.

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 18.12.2020
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Replacement:

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[9] also applies.

EXAMPLE 3         Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2-72[11] also applies.

EXAMPLE 4         Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70[10] also applies.

EXAMPLE 5         Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90[10] 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 the 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, 7.2.13 and 8.4.1.

NOTE 6       Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 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 drugs to patients.

NOTE 7       ISO 27427[6] specifies the safety and performance requirements for nebulizers.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 20.12.2020
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This document specifies 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 instructions for use. Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body.

This document is not applicable to tooth bleaching products:

—    specified in ISO 11609;

—    those 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          A tooth bleaching product can be evaluated for its biological safety using ISO 10993‑1[2] and ISO 7405[3].