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This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that may include:
— implant body,
— implant abutment,
— abutment screw,
— implant connecting part
— implant connecting part screw
— prosthetic screw,
— implant cover screw,
— transmucosal healing component.
This document includes requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.
The following devices are not included within the scope of this document:
— Dental implant incorporating animal or human components or bioactive characteristics,
— Custom-made devices that have no pre-fabricated connection,
— Implantable materials for bone filling and augmentation in oral and maxillofacial surgery,
— Membrane materials for guided tissue regeneration in oral and maxillofacial surgery,
— Specific instruments indicated to be used as part of a dental implant system.
NOTE 1 ISO 22794 gives the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 gives the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.
NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.
NOTE 3 Custom made devices are defined in the following document IMDRF/PMD WG/N49 - Definitions for Personalized Medical Devices.
NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied. NOTE 2 Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory. Specific requirements of medical device product standards or group standards take precedence over requirements of this document.
This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.
This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption, or retrograde root-end filling (Type 2).
The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.
This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopoeias can be made.
NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.
This document specifies the requirements and methods for the clinical investigation of ME equipment used to measure the body temperature in indirect measurement mode. This document covers both intermittently and continuously measuring clinical thermometers. NOTE For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient. This document specifies additional disclosure requirements. This document is not applicable to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.
This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system. This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: — intended for use with patients who can breathe spontaneously; and — intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed.
This document specifies requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.
These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical devices. This document specifies minimum requirements
for the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;
for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes;
for the test equipment and test procedures used to verify the sterilizer performance specified by this document.
This document does not specify requirements for equipment intended to process liquids, biological waste, or human tissues. This document does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.
NOTE: Attention is drawn to the standards for quality management, e.g. EN ISO 13485.
This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces.
This document 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.
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. This document applies to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and teat disinfection in the veterinary area – e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry. This document also applies to products used for teat disinfection in these veterinary areas.
This method is not applicable to evaluate the activity of hand hygiene products. For these products reference is made to EN 14885, which specifies in detail the relationship of the various tests to one another and to “use recommendations”.
NOTE This method corresponds to a phase 2 step 1 test.
This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.
This document also specifies components that are part of the sterilized subassembled syringe ready for filling.
This document is applicable to
— tubing-glass barrels (single-chamber design) for injection preparations, and
— sterilized subassembled syringes ready for filling.
Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.
Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document.
NOTE National or regional regulations such as Ph.Eur., USP, or JP can apply.
ISO 15621:2017 gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published testing procedures. General factors relating to incontinence products and their usage are also addressed.