Hälso- och sjukvård

Kommittébeteckning: SIS/TK 344 (Hjälpmedel för personer med funktionsnedsättning)
Källa: ISO
Svarsdatum: den 13 dec 2018
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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 applicable 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. However, it acknowledges that diverse sensory perceptions can impact cognitive accessibility.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 17 dec 2018
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This International Standard specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled ‘sterile’ and to CBHPs not labelled ‘sterile’.

This International Standard is not applicable to:

— procurement and transport of cell-based starting material used in processing of a CBHP,

— cell banking,

— control of genetic material,

— control of non-microbial product contamination,

in vitro diagnostics (IVDs), or

— natural medicines.

EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids.

This International Standard does not define biosafety containment requirements.

This International Standard does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.

Kommittébeteckning: SIS/TK 296 (Gasflaskor)
Källa: CEN
Svarsdatum: den 8 jan 2019
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This document specifies the requirements for valve protection caps, valve guards and shrouds used on cylinders for liquefied, dissolved or compressed gases.

Valve protection caps, valve guards or shrouds are some of the options available to protect cylinder valves (including Valves with Integral Pressure Regulators, abbreviated VIPRs) during transport.

While this document is applicable to valve protection caps, valve guards and shrouds which inherently provide the primary protection of a cylinder valve, it might also be beneficially used to test other equipment attached to cylinder packages, even in cases where the cylinder valve is inherently able to withstand damage without release of the content.

NOTE Small cylinders (e.g. medical) are commonly transported in an outer-packaging (e.g. pallet) to meet transport regulations.

This document does not specify requirements that might be necessary to enable the valve protection device to be used for lifting the cylinder.

Kommittébeteckning: SIS/TK 296 (Gasflaskor)
Källa: ISO
Svarsdatum: den 8 jan 2019
Se merSe mindre
 

This document specifies the requirements for valve protection caps, valve guards and shrouds used on cylinders for liquefied, dissolved or compressed gases.

Valve protection caps, valve guards or shrouds are some of the options available to protect cylinder valves (including Valves with Integral Pressure Regulators, abbreviated VIPRs) during transport.

While this document is applicable to valve protection caps, valve guards and shrouds which inherently provide the primary protection of a cylinder valve, it might also be beneficially used to test other equipment attached to cylinder packages, even in cases where the cylinder valve is inherently able to withstand damage without release of the content.

NOTE Small cylinders (e.g. medical) are commonly transported in an outer-packaging (e.g. pallet) to meet transport regulations.

This document does not specify requirements that might be necessary to enable the valve protection device to be used for lifting the cylinder.

Kommittébeteckning: SIS/TK 110 (Akustik och buller)
Källa: ISO
Svarsdatum: den 19 jan 2019
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This standard 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 practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss.

This standard 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 standard is the services offered to the majority of adult clients with hearing impairment. It is recognized that certain groups of hearing loss such as children, persons with other disabilities or persons with implantable devices may require services outside the scope of this standard.

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 must be observant of symptoms of such conditions and refer to proper medical care.

Further to the main body of the standard, that specifies the HAFM requirements and processes, several informative annexes are provided. Proper 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 education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D is a guidance on 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 course of HAFM. Annex F is a comprehensive terminology list offering definitions of most current terms related to HAFM.

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

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 5 feb 2019
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This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO/DIS 22442-1.

NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.

In addition, local safety regulation may be applied to ensure a clean basic handling of animals towards viral and bacterial loads (see also 5.5). The manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/or inactivation of viruses and TSE agents.

This document does not cover the utilization of human tissues in medical devices.

This document does not specify a quality management system for the control of all stages of production of medical devices.

It is not a requirement of this document to have a full quality management system during manufacture, but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. The quality management system elements that are required by this document can form a part of a quality management system conforming to ISO 13485.

NOTE 2 A general principle for the application of this International Standard is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.