Hälso- och sjukvård

This document specifies terminology, principles and a process for the clinical evaluation of medical devices. The process described in this document aims to assist manufacturers of medical devices to estimate the clinical risks associated with a medical device and evaluate the acceptability of those risks in the light of the clinical benefits achieved when the device is used as intended. The requirements of this document are applicable throughout the life cycle of a medical device. The process described in this document applies to the assessment of risks and benefits from clinical data obtained from the use of medical devices in humans. This document specifies general requirements intended to — verify the safety of medical devices when used in accordance with their instructions for use; — verify that the clinical performance or effectiveness of a medical device meet the claims of the manufacturer in relation to its intended use; — verify that there is sufficient clinical evidence to demonstrate the achievement of a positive benefit/risk balance when a medical device is used in the intended patient population in accordance with its intended use; — ensure the scientific conduct of a clinical evaluation and the credibility of conclusions drawn on the safety and performance of a medical device; — define the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation; and — assist manufacturers, clinicians, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Note 1 This standard can be used for regulatory purposes. Note 2 This document does not apply to in vitro diagnostic medical devices. However, there may be situations, dependent on the device and national or regional requirements, where sections and/or requirements of this document might be applicable.

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.