Hälso- och sjukvård

Kommittébeteckning: SIS/TK 340 (Biologisk säkerhet för medicintekniska produkter)
Källa: CEN
Svarsdatum: den 19 apr 2021
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This document describes characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force.
This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).
NOTE In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.

Kommittébeteckning: SIS/TK 164 (Konsument- och transportförpackningar)
Källa: ISO
Svarsdatum: den 19 apr 2021
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This International Standard specifies the test methods of the validation and the performance of the distribution packaging for medical devices that do not need sterilization. This document is intended to facilitate harmonized regulatory requirements for transport packaging of medical devices in good distribution practice principles.
This document does not cover any sterilization for medical device packaging, equipment and processing and quality assurance system in all stages of manufacture and does not guarantee the safety of medical devices.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Laboratoriemedicin)
Källa: CEN
Svarsdatum: den 27 apr 2021
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This document gives requirements on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests 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.
Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Kommittébeteckning: SIS/TK 340 (Biologisk säkerhet för medicintekniska produkter)
Källa: CEN
Svarsdatum: den 27 apr 2021
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This document specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel chromium- molybdenum 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 can differ from those specified in this document.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 4 maj 2021
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This document primarily specifies the geometrical aspects of the adult modular systems adapters used in lower limb prosthetic.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 4 maj 2021
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This document specifies requirements of water-absorbent crosslinked polyacrylate for urine absorbing products

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 8 maj 2021
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This part of ISO 10079 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use.

ISO 10079 Part 4 specifies general requirements for all medical suction equipment covered by the ISO 10079 series and is used as the basis for this Part 1.

The exemptions listed in ISO 10079-4, Clause 1 shall apply.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 8 maj 2021
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This part of ISO 10079 specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both.

The commonest use of manually powered suction is in situations outside of healthcare settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional/alternative requirements for manually powered suction equipment intended for field use or transport use are included in this part of ISO 10079.

ISO 10079 Part 4 specifies general requirements for all medical suction equipment covered by the ISO 10079 series and is used as the basis for this Part 2.

The exemptions listed in ISO 10079-4 Clause 1 shall apply. In addition this part of ISO 10079 does not apply to mucus extractors.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 8 maj 2021
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This part of ISO 10079 specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be stand-alone or part of an integrated system.

ISO 10079 Part 4 specifies general requirements for all medical suction equipment covered by the ISO 10079 series and is used as the basis for this Part 3.

The exemptions listed in ISO 10079-4, Clause 1, shall apply.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 8 maj 2021
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This part of ISO 8536 specifies the requirements for infusion sets that use light-protective agents in the fluid path materials (abbreviated as "light-protective infusion sets" henceforth).

This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 9 maj 2021
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This part of ISO 8980 specifies requirements for the transmittance properties of uncut finished spectacle

lenses and mounted pairs, including attenuation of solar radiation.

This part of ISO 8980 is not applicable to

⎯ spectacle lenses having particular transmittance or absorption characteristics prescribed for medical reasons;

⎯ products where specific personal protective equipment transmittance standards apply;

⎯ products intended for direct observation of the sun, such as for solar-eclipse viewing.

The fundamental requirements for uncut finished lenses, including reference to Clause 5.3 in this standard are

in ISO 14889.

NOTE Optical and geometric requirements for uncut finished spectacle lenses are specified in ISO 8980-1

and ISO 8980-2, and for mounted lenses, in ISO 21987.

Kommittébeteckning: SIS/TK 110 (Akustik och buller)
Källa: CEN
Svarsdatum: den 1 jun 2021
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This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss.

This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services.

The focus of this document is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices.

Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care.

Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM.

It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 2 jun 2021
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*This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.

This document includes gas-powered nebulizers which can be powered by, e.g., compressors, pipeline systems, cylinders, etc., and electrically powered nebulizers [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers.

This document does not specify the minimum performance of nebulizing systems.

*This document does not apply to:

a) devices intended for nasal deposition;

b) devices intended solely to provide humidification or hydration by providing water in aerosol form.

NOTE ISO 80601-2-74 [3] and ISO 20789[[4]] cover these devices.

*This document does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 4 jun 2021
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This document specifies a test method and the minimum requirements for the microbicidal activity of a chemical product which intended use is the chemical treatment of textiles in domestic area in order to evaluate the hygiene performance of domestic laundry products within domestic washing machines at low temperatures (≤40°C). This procedure will not apply to certain types of laundry disinfection technologies which require specific devices (i.e active substances generated in situ through the use of specific devices). This method is not limited to certain types of textiles, types of products or steps in the washing cycle.

This document can also apply to products that are used for chemical disinfection of textiles in food, industrial and institutional areas (e.g. food processing, shops, sport rooms, offices, hotels, workwear, foodstuff areas or similar institutions) but not when the disinfection is medical indicated (medical area).

NOTE This method corresponds to a phase 2, step 2 test (see EN 14885).

EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 5 jun 2021
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This International Standard, together with ISO 15004-1 and ISO 15004-2, specifies minimum requirements and test methods for hand-held direct ophthalmoscopes designed for directly observing the eye fundus.

This International Standard takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 8 jun 2021
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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.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 8 jun 2021
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This document provides essential performance and safety requirements for oro-tracheal and naso211 tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this document, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this document.

 Tracheobronchial (including Endobronchial) tubes, tracheostomy tubes, and supralaryngeal airways are excluded from the scope of this document.

 Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.

 NOTE Bibliography references [1] to [4] deal with laser surgery of the airway.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 13 jun 2021
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This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It  applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.

This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled.

Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.

NOTE: Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.

This document is not applicable to breathing sets and breathing tubes for special purposes.

 EXAMPLE 1: Ventilators having special compliance, pressure or breathing frequency requirements.

 Requirements for breathing system components such as exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heat and moisture exchangers (HMEs), breathing filters, and reservoir bags, are not covered by this document but can be found in ISO 80601-2-12, ISO 80601-2-13, ISO 9360- 1[3], ISO 23328-2[4], and ISO 5362[1]. Requirements for heated breathing tubes can be found in ISO 80601-2-74[2].