Hälso- och sjukvård

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method is for the determination of the pH of granular superabsorbent polyacrylates.

NOTE This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method determines the sum of residual monomeric sodium acrylate and acrylic acid present in polyacrylate (PA) superabsorbent powders as acrylic acid.

NOTE This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method specifies a method for measuring particle size distributions up to 850 μm of cross-linked polyacrylate superabsorbent powders. It applies only to measurements made where sieve shaking is used for the separation. Tapping equipment is not expected to deliver the same results.

In general, this method is expected to be applicable to powdered polymeric superabsorbent materials that are free-flowing under the specified test conditions.

NOTE - This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method covers the evaluation of mass loss upon heating for cross-linked polyacrylate superabsorbent powders.

In general, this method is expected to be applicable to powdered polymeric superabsorbent materials that are free-flowing under the specified test conditions. Substances other than water that are volatile in this temperature range will interfere.

NOTE - This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method determines the free swell capacity of polyacrylate superabsorbent powders in saline solution.

NOTE - This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method covers the determination of the fluid retention capacity of polyacrylate superabsorbent powders in saline solution, following centrifugation.

NOTE - This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method determines the capacity of polyacrylate superabsorbent powders to absorb saline solution under a specified enclosing pressure.

NOTE - This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method measures the absorption capacity of polyacrylate superabsorbent powder, where permeability is a significant controlling factor under the conditions of the test.

NOTE - This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method is used to determine the mass flow rate and bulk density (or apparent density) of polyacrylate superabsorbent powders.

NOTE - This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 1 nov 2019
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This test method is used to determine the mass fraction of soluble polymers present in crosslinked polyacrylate superabsorbent powders that may be extracted into saline solution.

NOTE - This standard does not claim to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. It is expected that the person performing this test has been fully trained in all aspects of this procedure.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 11 nov 2019
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This document specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination on hands when rubbed onto the artificially contaminated hands of volunteers.

NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions.

This document applies to products for hygienic handrub for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:

– in hospitals, in community medical facilities and in dental institutions;

– in clinics of schools, of kindergardens and of nursing homes;

and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patient.

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

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

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 17 nov 2019
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This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.

This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:

- anaesthetic gas delivery system;

anaesthetic breathing system;

- anaesthetic gas scavenging system;

- anaesthetic vapour delivery system;

- anaesthetic ventilator;

- monitoring equipment;

- alarm system;

- protection device.

NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.

An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard.

NOTE 2 The applicability of this document is indicated in Table AA.2.

This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.

If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components including accessories, as relevant.

Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

NOTE 3 See also 4.2 of the general standard.

This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 11 dec 2019
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This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. 

* Sleep apnoea breathing therapy equipment is not considered to utilize physiologic closed-loop control system unless it uses a physiological patient variable to adjust the therapy settings. 

This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.

This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation.

This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea.

This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.

Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.

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 say so. If 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 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the General Standard.

This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs) [1], which are given in ISO 80601-2-87 [3].

This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-12. [4]

This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. [5]

This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. [6]

This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 10651-32). [7]

This document does not specify the requirements for ventilators or accessories intended for homecare ventilatory support, which are given in ISO 80601-2-79 [8] and ISO 80601-2-80.

This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 16 dec 2019
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This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.

EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.

NOTE 1 The Luer connector was originally designed for use at pressures up to 300 kPa.

This part of ISO 80369 does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.

This part of ISO 80369 does not specify requirements for the following small-bore connectors, which are specified in other documents:

— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports);

— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637);

— infusion system closure piercing connectors (ISO 8536-4).

NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.

NOTE 3 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this part of ISO 80369.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 16 dec 2019
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ISO 18190:2016 Clause 1 is replaced by the following

This document specifies essential performance and safety requirements for cuff pressure indicator devices used to indicate the intracuff pressure of airway devices. Such devices are primarily designed to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes. This standard is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device may also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range.