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ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm. It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device. It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge). It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.

This document specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this document. This document also specifies terms and definitions which are used in European Standards. It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages). It is intended to: a) enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product; b) enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product; c) assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market. It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas. In the area of human medicine (Working Group 1, i.e. WG 1), it is applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care — in hospitals, in community medical facilities, dental institutions and medical laboratories for analyses and research, — in clinics of schools, of kindergartens and of nursing homes, — and may also occur in the workplace and in the home. It may also include services such as in laundries and kitchens supplying products directly for the patient. In the veterinary area (WG 2) it is applicable to chemical disinfectants and antiseptics to be used in the areas of breeding, husbandry, veterinary care facilities, production, transport and disposal of animals and veterinary laboratories for analyses and research. It is not applicable to chemical disinfectants used in the food chain following death and entry to the processing industry. In food, industrial, domestic and institutional areas (WG 3) it is applicable to chemical disinfectants and antiseptics to be used in processing, distribution and retailing of food of animal or vegetable origin. It is also applicable to products for all public areas where disinfection is not medically indicated (homes, catering, schools, nurseries, transports, hotels, offices etc.) and products used in packaging, biotechnology, laboratories (except laboratories for veterinary and medical analyses and research), pharmaceutical, cosmetic etc. industries. This document is also applicable to active substances and products under development for which no area of application has yet been specified. This document will be periodically updated to reflect the current published versions of each standard developed in CEN/TC 216. Independent of this update newly published standards are to be used, even if they are not yet mentioned in EN 14885. This document does not refer to methods for testing the toxicological and ecotoxicological properties of products or active substances.

ISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations. The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time. ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).

ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices.

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.