Hälso- och sjukvård

This document specifies requirements for the respiratory tubing and connectors used to convey respirable gases to a patient in the healthcare and homecare environments and provide a safe connection between the gas supply device and the patient interface. Respiratory tubing and connectors are mainly used for delivery of oxygen but can also be used for respirable air or oxygen/air mixtures and breathable medicinal gas mixtures such as oxygen/nitrous oxide or oxygen/helium mixtures. This document also specifies requirements for respiratory therapy extension tubing. NOTE 1       The gas supply devices referred to in this document do not include anaesthetic machines/workstations and ventilators. NOTE 2       This document does not cover breathing tubes for breathing systems. These are specified in ISO 5367. This document is written following the format of ISO 18190, General standard for airways and related equipment. The requirements in this device-specific standard take precedence over any conflicting requirements in the General standard

This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included. This document does not address setting specific endotoxin limit specifications.

This document specifies the requirements for valve protection caps and valve guards used on cylinders for liquefied, dissolved or compressed gases. Valve protection caps and valve guards are some of the options available to protect cylinder valves, including valves with integral pressure regulators (VIPRs) during transport. This document is applicable to valve protection caps and valve guards which inherently provide the primary protection of a cylinder valve. It can also be used to test other equipment (e.g., handling devices) attached to cylinder packages, even in cases where the cylinder valve is inherently able to withstand damage without release of the content. This document excludes protection devices for cylinders with a water capacity of 5 l or less and cylinders whereby the protection device is fixed by means of lugs welded or brazed to the cylinder, or is welded or brazed directly to the cylinder. This document does not cover valve protection for breathing apparatus cylinders. NOTE Small cylinders (e.g., medical cylinders) are commonly transported in an outer-packaging (e.g., pallet) to meet transport regulations. This document does not specify requirements that could be necessary to enable the valve protection device to be used for lifting the cylinder.

This document specifies requirements for waste volatile anaesthetic agent capture systems that may or may not include the recycling of the collected volatile anaesthetic agent for reuse. NOTE 1: Waste volatile agent capture systems, that are part of a medical gas pipeline system as specified in ISO 7396-1 [4], are outside the scope of this document. NOTE 2: Nitrous oxide is not considered to be a volatile anaesthetic agent.

This document specifies the requirements for acrylic hard type materials used as chairside denture lining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer. Dentures which are relined by hard type denture lining materials specified by this document are limited to those of acrylic. This document is not applicable to soft type denture lining materials.

This document specifies test methods and values for single-use sealable pouches and reels constructed of a porous material as specified in EN 868 part 2, 3, 6, 7, 9 or 10 and a plastic film. These sealable pouches and reels are intended to be used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.

This document specifies test methods and values for uncoated nonwoven materials of polyolefins used for single-use sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.

Omfattning

I detta dokument anges krav för och konstruktionsbeskrivning av överdragsrock med lång eller kort ärm avsedd för personal inom hälso- och sjukvård. Överdragsrocken är inte avsedd för att skydda personalen i enlighet med förordning (EU) 2016/425 om personlig skyddsutrustning (PPE).

Tillskärningsmönstret SS 8760126 säljs separat på https://www.sis.se.

This document specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefins, manufactured from nonwovens specified in EN 868-9 used for single-use sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.

This document specifies test methods and values for re-usable containers used as sterile barrier systems for terminally sterilized medical devices. These containers are intended to be used in large steam sterilizers as specified in EN 285. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document. This document does not cover additional materials and/or accessories inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device).

This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

This document specifies requirements for soft type denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis, and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer. This document is not applicable to hard type denture lining materials or soft type denture lining materials for long-term use.

This document specifies requirements for soft type denture lining materials suitable for long-term use and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer. These materials may also be used for maxillofacial prostheses. This document is not applicable to hard type denture lining materials or soft type denture lining materials for short-term use.

ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.

This document specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826. The integrated features refer to: needle stick protection device, leucocyte filter, sterile barrier filter, pre-collection sampling device, red blood cell storage bag, plasma storage bag, platelet storage bag, polymorphonucleic (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid. This document specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.

ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). The integrated features refer to: leucocyte filter; pre-donation sampling device; top and bottom bag; platelet storage bag; needle stick protection device. In addition to ISO 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units. Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.

This document addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users. The symbols specified in this document do not replace current national regulatory requirements. Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation. As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This document proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings. This document is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling. This document may also be of assistance to different stages of the blood supply chain, e.g.: distributors of blood collection devices (manual or automated) or other representatives of manufacturers; blood centres and distribution centres to simplify and secure the operating procedures. The use of these symbols is primarily intended for the medical device rather than the therapeutic product. This document does not specify requirements relating to the size and colour of symbols although the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing. Several of the symbols specified in this document may be suitable for application in other areas of medical technology.

This document specifies a test method for measuring the forces needed for the placement and removal of dental attachments (frictional retention elements of ball head-, snap-on, prefabricated telescopic and bar systems used for the attachment, support and stabilization of crowns and bridges, single attachments, removable partial dentures, complete dentures, and other superstructures on dental implant systems (including monopart implants)and, if not other justified, on natural teeth and root post copings). If not otherwise justified, this document can also be used for tests on custom-made or patient matched devices (e.g. laboratory manufactured). This test method is not applicable to retention devices for which normal placement and removal requires any off-axis rotation for the path of least resistance. This test method is not applicable to dental magnetic attachments, these are specified in ISO 13017.

ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.

ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.