Hälso- och sjukvård

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 21 dec 2017
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This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.

This document is not applicable to syringes made of glass (specified in ISO 595 (withdrawn)), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this document.

NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this part of ISO 7886 with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 15 jan 2018
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This document specifies a set of representational primitives and semantic relations required for an unambiguous representation of explicit time-related expressions in health informatics. This document does not introduce or force a specific ontology of time, nor does it force the use of a fixed representation scheme for such an ontology. Rather this document provides a set of principles for syntactic and semantic representation that allow the comparability of specific ontologies on time, and the exchange of time-related information that is expressed explicitly.

This document is applicable to:

1) developers of medical information systems in which the need is felt to have explicit timerelated concepts for internal organization (e.g. temporal data bases, temporal reasoning systems);

2) information modellers or knowledge engineers building models for the systems mentioned in (1);

3) experts involved in the development of semantic standards on precise subdomains in health care where time-related information need to be covered, (e.g. in the study of Pathochronology, i.e. the discipline dealing with the time course of specific diseases);

4) developers of interchange formats for messages in which time-related information is embedded.

This document is not intended to be used directly for:

1) representing what is true in time;

2) reasoning about time;

3) representation of metrological time (which is covered in other standards).

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 15 jan 2018
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This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectants and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.

This European Standard applies to products that are used in the veterinary area on porous surfaces without mechanical action i.e. in the breeding, husbandry, production, veterinary facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.

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

NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.

NOTE 2 This method corresponds to a phase 2 step 2 test.

NOTE 3 This method cannot be used to evaluate the activity of products against mycobacteria or bacterial spores.

Kommittébeteckning: SIS/TK 445 (Teckenrepresentation och användargränssnitt)
Källa: ISO
Svarsdatum: den 17 jan 2018
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This document identifies a collection of user accessibility needs that diverse users have of ICT systems to make these systems accessible to them. Each user accessibility need might be required of a system by an individual. Different users can have different sets of user accessibility needs in different contexts.

While this set of user accessibility needs was developed for the domain of ICT, many of the user accessibility needs in this set also apply in other domains.

This document does not provide requirements or specific processes and methods for the application and evaluation of user accessibility needs. However, it could inform the development of such requirements [see 5.4].

This document is not designed for certification purposes or regulatory or contractual use.

The user accessibility needs in this document are intended to inform and encourage those responsible for accessibility to go beyond the minimum provisions of accessibility legislation and regulations.

Kommittébeteckning: SIS/TK 211 (Hissar och rulltrappor)
Källa: CEN
Svarsdatum: den 29 jan 2018
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1.1 This European Standard deals with safety requirements for construction, manufacturing, installation, maintenance and dismantling of electrically operated stairlifts (chair, standing platform and wheelchair platform) affixed to a building structure, moving in an inclined plane and intended for use by persons with impaired mobility:

— travelling over a stair or an accessible inclined surface;

— intended for use by one person;

— whose carriage is directly retained and guided by a guide rail or rails;

— supported or sustained by rope (5.4.4), rack and pinion (5.4.5), chain (5.4.6), friction traction drive (5.4.7), and guided rope and ball (5.4.8).

1.2 The standard identifies hazards as listed in Clause 4 which arise during the various phases in the life of such equipment and describes methods for the elimination or reduction of these hazards when used as intended by the manufacturer.

1.3 This European standard does not specify the additional requirements for:

— operation in severe conditions (e.g. extreme climates, strong magnetic fields);

— operation subject to special rules (e.g. potentially explosive atmospheres);

— handling of materials the nature of which could lead to dangerous situations;

— use of energy systems other than electricity;

— hazards occurring during manufacture;

— earthquakes, flooding, fire;

— evacuation during a fire;

— stairlifts for goods only;

— concrete, hardcore, timber or other foundation or building arrangement;

— design of anchorage bolts to the supporting structure.

NOTE For the actual type of machinery, noise is not considered a significant nor relevant hazard.

1.4 This document is not applicable to power operated stairlifts which are manufactured before the date of publication of this document by CEN.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 6 feb 2018
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