Hälso- och sjukvård

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.

Kommittébeteckning: SIS/TK 296 (Gasflaskor)
Källa: CEN
Svarsdatum: den 30 mar 2020
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This document concerns pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar and/or test pressure up to a maximum of 300 bar.

NOTE This type of connection is primarily used for small cylinders (5 l or below).

It 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 the gases and gas mixtures given in Table 1.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 31 mar 2020
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This document specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are supplied after refurbishment.

NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.

This document also applies to instruments which can be connected to power-driven systems, but does not apply to the power-driven systems themselves.

With regard to safety, this document gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.

This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.

Ämnesområden: Utrustning för ögonoptik
Kommittébeteckning: SIS/TK 336 (Ögonoptik)
Källa: CEN
Svarsdatum: den 12 apr 2020
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This document specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of user of contact lenses: the eye care professional and the contact lens wearer.

This document does not specify the format in which such information shall be provided.

Kommittébeteckning: SIS/TK 599 (Kvalitetssäkring inom LSS)
Källa: SIS
Svarsdatum: den 17 apr 2020
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Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 28 apr 2020
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This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made to minimize pain and distress, which can negatively affect the validity of the data. This document is for those who commission, design and perform testing or evaluate the data to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.

This document makes recommendations and offers guidance intended to facilitate further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.

This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on  isolated tissues and organs taken from vertebrate animals that have been euthanized.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 29 apr 2020
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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.

This document includes:

— details of in vivo sensitization test procedures;

— key factors for the interpretation of the results.

NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.