Hälso- och sjukvård

Kommittébeteckning: SIS/TK 536 (Samordningsgrupp för tillgänglighet)
Källa: CEN
Svarsdatum: den 23 okt 2017
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This document specifies requirements that enable an organization to design, develop and provide products, goods or services so that they can be accessed, understood and used by the widest range of users.

This document specifies requirements and recommendations that enables an organization to extend their range of users by identifying diverse needs, characteristics, capabilities, and preferences, by directly or indirectly involving users, and by using knowledge about accessibility in its procedures and processes.

This document specifies requirements that can enable an organization to meet applicable statutory and regulatory requirements as related to accessibility of its products, goods or services.

The requirements set out in this document are generic and are intended to be applicable to all relevant parts of all organizations, regardless of type, size or products, goods or services provided.

This document promotes accessibility following a Design for All approach in mainstream products, goods and services and interoperability of these with assistive technologies.

This document does not provide technical design specifications and does not imply uniformity in design or functionality of products, goods and services.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 30 okt 2017
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This International Standard defines terms in the field of sterilization of healthcare products used in the standards developed by ISO TC198 "Sterilization of healthcare products", CEN TC204 "Sterilization of medical devices", and CEN TC102 "Sterilizers and associated equipment for processing of medical devices".

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 30 okt 2017
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This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creation of a single dental restoration.

This document specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking.

This document is not applicable to dental amalgam alloys supplied as a free-flowing powder in bulk quantities or as powder compressed into tablets, or to dental mercury supplied in sachets or bulk quantities.

This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration.

Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this document. For the assessment of possible biological hazards, reference can be made to ISO 10993-1 and ISO 7405.

The scope of this document is restricted to dental amalgam products marketed in pre-capsulated form alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are within the scope of ISO 24234.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 6 nov 2017
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This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 22 nov 2017
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This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.

This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture.

This part of ISO 11607 does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 22 nov 2017
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This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.

This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 1 dec 2017
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Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 4 dec 2017
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This standard establishes a normative defi nition of communication between devices containing a power source (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) in a manner that enables plug-and-play interoperability. Using existing terminology, information profi les, application profi le standards, and transport standards as defi ned in other ISO/IEEE 11073 standards, this standard defines a common core of communication functionality of personal health devices (PHDs) containing a battery, including: 1) current device power status (e.g., on mains or on battery); 2) power charge status (e.g., percent of full charge); and 3) estimated time remaining (e.g., minutes).

Ämnesområden: Övrig medicinsk utrustning
Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 8 dec 2017
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This document specifies requirements for single-use sharps containers intended to hold potentially hazardous sharps medical waste with or without sharps protection features, e.g. scalpel blades, trocars, hypodermic needles and syringes.

It is applicable to sharps containers that are supplied complete by the manufacturer and to those that are supplied as components intended to be assembled by the user.

It is not applicable to reusable sharps containers or the outer containers used in the transportation of filled single-use sharps containers.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 10 dec 2017
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Replacement: This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT intended:

for those PATIENTS who can be dependent on artificial ventilation;

for use in an environment, which provides specialized care of PATIENTS whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a PROFESSIONAL HEALTHCARE FACILITY; and

NOTE 1 For the purposes of this standard, this includes transport within a PROFESSIONAL HEALTHCARE FACILITY (i.e. a TRANSIT OPERABLE VENTILATOR).

NOTE 2 A critical care VENTILATOR intended for use in transport within a PROFESSIONAL HEALTHCARE FACILITY is not considered an emergency and transport ventilator. 

to be attended by a HEALTHCARE PROFESSIONAL OPERATOR.

NOTE 3 Such VENTILATORS are considered life-sustaining.

NOTE 4 For the purposes of this standard, such an environment is referred to as a critical care environment.

This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYSTEM, or to a VENTILATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will s ay so. I f that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. 

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.

NOTE 5 Additional information can be found in IEC 60601-1:2005, 4.2. 

This document is not applicable to ME EQUIPMENT or an ME SYSTEM operating in ventilation modes intended for PATIENTS who are not dependent on artificial ventilation.

NOTE 6 A critical care VENTILATOR, when operating in such a mode, is not considered life-sustaining.

This document is not applicable to ME EQUIPMENT that is intended solely to augment the ventilation of spontaneously breathing PATIENTS within a PROFESSIONAL HEALTHCARE FACILITY.

This document does not specify the requirements for

VENTILATORS or ACCESSORIES intended for anaesthetic applications, which a re g iven in ISO 80601-2-13 [2].  

VENTILATORS or ACCESSORIES intended for emergency and transport, which are given in ISO 80601-2-84 [3], the future replacement for ISO 10651-3 [4]. 

VENTILATORS or ACCESSORIES intended for VENTILATOR-DEPENDENT PATIENTS in the HOME HEALTHCARE ENVIRONMENT, which are given in ISO 80601-2-72 [5]. 

VENTILATORS or ACCESSORIES intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 [6] and ISO 80601-2-80 [7], the replacements for ISO 10651-6 [8]. 

sleep apnoea therapy ME EQUIPMENT, which are given in ISO 80601-2-70 [9]. 

continuous positive airway pressure (CPAP) ME EQUIPMENT. 

high-frequency jet ventilators (HFJVs). 

high-frequency oscillatory ventilators (HFOVs) [10]. oxygen therapy constant flow ME EQUIPMENT.

cuirass or "iron-lung" ventilation equipment.

This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel för personer med funktionsnedsättning)
Källa: ISO
Svarsdatum: den 13 dec 2017
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This part of ISO 7176 specifies test methods for determining the maximum speed and deceleration of electrically powered wheelchairs, including scooters, intended to carry one person with a maximum nominal speed not exceeding 15 km/h (4,167 m/s) on a level surface.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 16 dec 2017
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This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant 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. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.

This European Standard document applies to products that are used in the veterinary area – e.g. in veterinary care facilities, breeding, husbandry, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.

This European Standard applies to products that are used in the veterinary area in the fields of, equipment disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and teat disinfection.

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 1 test.

NOTE 3 This method cannot be used to evaluate the activity of hand hygiene products. For these products reference is made to EN 14885.