Hälso- och sjukvård

Kommittébeteckning: SIS/TK 115 (Språk och terminologi)
Källa: ISO
Svarsdatum: den 5 feb 2020
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This International document establishes requirements for healthcare interpreting services in spoken and signed communication. Healthcare interpreting services: a) enable safe communication mainly between healthcare providers and patients b) provide linguistic access to healthcare services, and c) ensure patient safety. This International document is applicable to all situations requiring healthcare interpreting, where the parties involved need to communicate orally, or by signed language, to resolve a health-related issue. It covers all parties involved in facilitating communication in healthcare settings. However, it does not supersede national, state or provincial regimes or legislation, which govern interpreting services in healthcare, where applicable.

The objectives of this document are: a) to establish minimum requirements; b) to promote market transparency in the field of healthcare interpreting; c) to provide information and clarification for users of healthcare interpreting services.

This document is aimed at individuals, the users of these services and all parties involved in the work of healthcare interpreting:

— Healthcare interpreters

— Interpreting service providers

— Patients and accompanying persons

— In-house interpreter departments

— Government agencies

— Non-profit organizations

— Community organizations that provide interpreting services

— Employees that provide interpreting services

— Professional associations

— Healthcare organizations

— Educators and researchers

— Healthcare providers and staff

— Healthcare policy writers

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 9 feb 2020
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This International Standard establishes a vocabulary of terms used for anaesthetic and respiratory equipment and supplies, related devices and supply systems.

Note 1 to entry This International Standard is based on standards and drafts which have been produced by ISO/TC 121 and CEN/TC 215.

Note 2 to entry Contrary to the policy in ISO 4135 3rd edition of allowing multiple definitions of the same term in different categories, this document attempts to ensure consistency by the inclusion of a ‘general’ category, and by use of domain specifiers and unique pre-coordinated domain-specific term names.

Note 3 to entry In addition to terms and definitions used in two of the three official ISO languages (English and French), this International Standard gives the equivalent terms in the German language; these are published under the responsibility of the member body for Germany. However, only the terms and definitions given in the official languages can be considered as ISO terms and definitions.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 26 feb 2020
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This document specifies the requirements and methods for the clinical investigation of continuous non-invasive automated sphygmomanometers used for the measurement of the blood pressure of a subject.

Since this document covers both trending devices and absolute accuracy devices and focuses solely on requirements for the clinical investigation, representation of output is not covered by this document.

NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices which can be used to clarify for the intended user whether the shown data concerns absolute accurate values or trending values.

The requirements and methods for the clinical investigation of continuous non-invasive automated sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous non-invasive automated sphygmomanometers.

NOTE 2 Subject populations can, for example, be represented by age or weight ranges.

NOTE 3 Conditions of use can, for example, refer to ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment or self-measurement as well as use in professional healthcare facility or the emergency medical service environment (EMS).

This document specifies additional disclosure requirements for the accompanying documents of continuous non-invasive automated sphygmomanometers that have undergone clinical investigation according to this document.

This document is not applicable to the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1, the clinical investigation of an intermittent automated sphygmomanometer as given in ISO 81060-2, an intermittent automated non-invasive sphygmomanometer as given in IEC 80601-2-30 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: CEN
Svarsdatum: den 16 mar 2020
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This document provides a classification and defines terms for absorbent incontinence products.

The document builds on ISO 9999, Assistive products for persons with disability — Classification and terminology, sub-class 09 30 – Absorbing products to contain urine and faeces. This document also provides preferred terms, additional terms and example pictures.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 18 mar 2020
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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.