Hälso- och sjukvård

Kommittébeteckning: SIS/TK 595 (Trycksårsprevention)
Källa: CEN
Svarsdatum: den 29 aug 2021
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This document specifies general requirements and related test methods that are relevant to assistive products for tissue integrity (APTI) in the lying position in different application environments such as hospitals, home care and institutions. This document applies to the safety of APTI, which are intended to remain in situ during periods of lying, and to prevent and/or treat pressure injuries.
This document covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform or as a whole integrated system.
This document also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position.
This document does not apply to lying support surfaces used in combination with incubators.
This document addresses the combination of a full body support surface and an adjustable mattress support platform. It also covers safety and performance test methods to ensure protection against injuries to the user.
This document specifies requirements and test methods for APTI within the following classifications of ISO 9999:2016:
04 33 06 Assistive products for tissue integrity when lying down such as but not limited to:
— Mattresses and mattress overlays for pressure injury prevention;
— Mattress coverings for pressure injury prevention mattresses.
12 31 03 Assistive products for sliding and turning such as but not limited to:
Devices for changing position or direction of a person using sliding or turning techniques. The only products included are those intended to be used in a lying position and remain in situ as part of the lying support surface. They are the following:
— sliding products that glide one way and lock the other way;
— sheets and underlays in flexible materials with low friction;
— fabric sold by the metre, cut as required for repositioning use;
— powered turning product;
This excludes sliding boards unless the produc ...

Ämnesområden: Dentala implantat
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 13 sep 2021
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This document specifies a test method to evaluate the adaptability between an implant body and an implant abutment in a dental implant system.
This document may be applicable to the implant systems which do not have a friction-fit between implant body and implant abutment but incorporate an anti-rotational feature between these components. It is not acceptable to use analog or replica components to evaluate adaptability of dental implant systems.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: ISO
Svarsdatum: den 20 sep 2021
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This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers that comply with EN 13060. The suitability of the hollow and porous devices described in this document as surrogate devices for hollow and porous medical devices used in health care facilities is not substantiated. Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). The relevant sections of this document covering porous loads specify the requirements for: a) a reference porous device as a reference device by which alternative porous indicator systems can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means; b) an alternative porous indicator system equivalent in performance to the reference porous device, i.e. an alternative porous indicator system, usually commercially manufactured, of any design. Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060). The relevant sections of this document covering hollow loads specify the requirements for: a) a reference hollow device used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator; b) an alternative hollow device: i. employing the same specific test load as defined for the reference hollow device and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator; ii. equivalent in performance to the reference hollow device, i.e. an alternative hollow device, usually commercially manufactured, of any design.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 20 sep 2021
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This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User powered resuscitators are designated according to ideal body mass range.
 NOTE 1 Patients being treated with a resuscitator can be ventilator-dependent.
Example user-powered resuscitators include:
  self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and 

 NOTE 2 Self-inflating bag resuscitators are generally transit-operable.
  flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by flow from a medical gas source.
 This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator.
 Examples of such accessories include such as masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, point-of-use packaging, electronic feedback devices, electronic sensors and transmission of data to other equipment.
 This document does not specify the requirements for:
  gas-powered emergency resuscitators, which are given in ISO 10651-5[8];
 electrically-powered resuscitators;
 gas powered resuscitators for professional healthcare facilities; and
 anaesthetic reservoir bags, which are given in ISO 5362[4].
 NOTE 3 This document has been prepared to address the relevant essential principles[22] and labelling[23]
guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
 NOTE 4 This document has been prepared to address the relevant essential principles of safety and performance of
ISO 16142-1:2016[11] as indicated in Annex E.
 NOTE 5 This document has been prepared to address the relevant general safety and performance requirements
 of European regulation (EU) 2017/745[21] as indicated in Annex F.

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: ISO
Svarsdatum: den 20 sep 2021
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This document specifies requirements and test methods for metallic materials that are suitable for the fabrication of dental restorations and appliances. Included are metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses. Furthermore, it specifies requirements with respect to packaging and marking of the products and to the instructions for use of these materials, including products delivered for sale to a third party.
This document also applies to products, which were produced using additive and subtractive manufacturing.
This document does not apply to alloys for dental amalgam (ISO 24234), dental brazing materials (ISO 9333), or metallic materials for orthodontic appliances (ISO 15841) (e.g. wires, brackets, bands and screws).
This document is not applicable to magnetic attachment, which are specified in ISO 13017.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 28 sep 2021
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This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.