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ISO 16671:2015 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer. ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

This document specifies the competencies required of assistance dogs’ professionals. The purpose of this document is to improve and ensure the quality of professionals working in a role within an assistance dog organization. Each speciality of assistance dog requires a specific set of role competencies and there are some common core competencies. Core competencies: - breeding; - puppy raising; - dog care; - assessors; - orientation and mobility; - trainers; - instructors. Specific competencies: - guide dogs; - hearing dogs; - medical alert dogs; - mobility assistance dogs; - autism and development disorder dogs; - team training instructor. It is accepted that assistance dog organisations vary greatly in structure and not every organization will have all the roles identified. Where one person performs more than one role, it is expected that they will have the competencies of all the roles they perform e.g. a dog trainer may also have the competencies of a dog care specialist. And there will be some organisations where some of these roles are not required, e.g. those with no breeding programme will not require the associated role competencies.

This document specifies general requirements and test methods for metallic dental elevators. In addition it specifies dimensional requirements for specific types of dental elevators such as Warwock James, Cryer, Coupland, Bein and Flohr elevators.

This document specifies a test method for the measurement of residual chemicals used in product manufacture, particularly potentially allergenic substances employed and remaining in medical gloves. It also provides information on the extraction vehicle, the method of extraction and quantitative assay of residual chemicals. This document does not provide information on the allergenic potential, biological evaluation, or safety to the user of any product.

Omfattning: I detta dokument anges krav och konstruktionsbeskrivning och separata tillskärningsmönster för barnkofta i unisexmodell.

This document specifies requirements and test methods for lead-acid batteries and their chargers intended for use with electrically-powered wheelchairs and scooters. Requirements for chargers are applicable to those with a rated input voltage not greater than 250 V AC and a nominal output voltage not greater than 36 V.

This document specifies a test method and the minimum requirements for bactericidal activity of teat disinfectants that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - with water. This method applies to teat disinfectants that are used on teat skin without mechanical action as pre-milking and/or post-milking teat disinfectants 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. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2 step 2 test.

This document specifies requirements and associated test methods for the power, and control systems of electrically powered wheelchairs and scooters. It sets safety and performance requirements that apply during normal use and some conditions of abuse and failure. It also specifies methods of
measurement of the forces necessary to operate controls and sets limits on the forces needed for some operations.
This document is applicable to electrically powered wheelchairs and scooters with a maximum speed no greater than 15 km/h intended to provide indoor and/or outdoor mobility for one disabled person whose mass lies in the range specified in ISO 7176-11.

This document specifies the requirements for sterilized, single-use, gravity feed infusion sets used together with the volumetric infusion controllers. NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator. NOTE 1 Conserving equipment can also be used in professional health care facilities. This document is also applicable to conserving equipment that is incorporated with other equipment. EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4]. This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment. This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling. This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas). If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircraft. NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities. This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems. EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function. EXAMPLE 2 An oxygen concentrator used with a flowmeter stand. EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2]. EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function. This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator. NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE 3 See also 4.2 of the general standard.

This document specifies requirements for the physical and chemical properties of dentifrices and provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and packaging of dentifrices. This document applies to dentifrices, including toothpastes, destined to be used by the consumers on a daily basis with a toothbrush to promote oral hygiene. Specific qualitative and quantitative requirements for freedom from biological and toxicological hazards are not included in this document. These are covered in ISO 7405 [1] and ISO 10993-1 [2].

1) Nomenclature developed by the Personal Care Products Council (formerly CTFA). Available at: https://access .personalcarecouncil.org/eweb/DynamicPage.aspx?Site=pcpc&WebKey=4513b14e-2f75-4857-85b4-b3697be5d5d9

2) ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.