Hälso- och sjukvård

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.

ISO 16840-6:2015 specifies apparatus, test methods, and disclosure requirements for generating aging effects in a seat cushion that reproduce those seen in use. It also provides methods of determining changes in the physical and mechanical properties of seat cushions based on their age and use. ISO 16840-6:2015 provides a set of tests that simulate wear and tear, which can be useful to validate warranty claims and to provide information about product, life, and performance limitations associated with product use.

This document specifies requirements and technical specifications for information in tactile lettering in the built environment. It sets out rules for content, design, arrangement and application of information elements so that blind and partially sighted people are able to locate, identify, fluently read and interpret this information. This document does not describe technical methods for producing tactile lettering. This document only applies to permanently installed tactile lettering.

This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD. The range of products on which WD of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two.

This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Six grades of titanium based on tensile strength are listed in Table 2. NOTE The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily comply with those specified in this document.

This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This document applies to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators could have internal power supply (rechargeable battery powered) or be connected to external (mains) power supply. Lasers or plasma arc devices are not covered by this standard. This document does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.