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This document provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use.

This document is applicable only to those degradation products generated by chemical alteration of the final metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments.

This document considers both materials designed to degrade in the body as well as materials that are not intended to degrade.

This document is not applicable to degradation products induced by applied mechanical stress.

Mechanically induced degradation, such as wear, can be covered in the appropriate product-specific standard. Where product-group standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards should be considered.

Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (< 10 –6 w/w) contained in the specific metal or alloy is not addressed in this part of ISO 10993, nor are specific requirements for acceptable levels of degradation products provided in this part of ISO 10993.

This document does not address the biological activity of the degradation products; see instead the applicable clauses of ISO 10993-1 and ISO 10993-17.

This part of ISO 24409 prescribes general design principles for shipboard safety and fire control signs, markings, and notices intended to communicate safety-related information to persons on board ships.

This document specifies the connecting dimensions of WC pans and WC suites regardless of the materials used for their manufacture.

This document does not apply to siphonic action WC pans and WC suites.

NOTE 1 Other connecting dimensions are permitted, e.g. special designs of WC pans, if the manufacturer supplies or recommends the appropriate fittings.

NOTE 2 The shape of the appliance in the figures is for illustration only; it in no way prejudices the final shape of the appliance, which is left to the initiative of the manufacturer.

This document specifies a method of determining the spectral response of ultraviolet and visible radiation for all kinds of plastic material, by spectrally dispersed irradiation.

NOTE Typical specimens that are evaluated include; films, liquids, plaques, pellets, powders, sheets and discs.

This standard specifies an analytical method to quantify the nicotine, propylene glycol and glycerol content in e-liquids by gas chromatography.

This part of ISO 18218 is a method for determining alkylphenols (nonylphenol and octylphenol) and alkylphenol ethoxylates (nonylphenol ethoxylate and octylphenol ethoxylate) in leather and process auxiliaries. The analysis is based on high-performance liquid chromatography (HPLC) or gas chromatography-mass spectrometry (GC-MS).

The analysis of the alkylphenol ethoxylate is made by cleaving the alkylphenol ethoxylate and measuring the released alkylphenol.

NOTE ISO 18218-1 and this part of ISO 18218 use different solvents for the extraction of the ethoxylated alkylphenols from leather. Consequently, the two analytical methods are expected to give similar trends but not necessarily the same absolute result for the ethoxylated alkylphenol content in leather.

This European Standard specifies a test method for assessing the tear strength of upper, linings and insocks or complete upper assembly, irrespective of material, in order to assess the suitability for the end use.

This European Standard specifies a test method for determining the resistance of a footwear upper material to water penetration on flexing, in order to assess the suitability for the end use.

This European Standard specifies a test method for determining the effect of heat on the tensile strength of uppers or complete upper assembly irrespective of the material, in order to assess the suitability for the end use.

This European Standard specifies a test method for determining the thermal conductivity of uppers, lining and insocks irrespective of the material, in order to assess the suitability for the end use.

This standard specifies a test method for determining the force required to break a test specimen from uppers irrespective of the material, in order to asses the suitability for the end use.

This European Standard specifies the sampling location, preparation and duration of conditioning of samples and test pieces for footwear components and footwear, to carry out the test methods needed to determine the suitable properties for the end use.

These are the general conditions unless otherwise stated in the corresponding test method.

This European standard specifies a method for assessing the fatigue resistance of steel shanks used for the reinforcement of the waist region of women’s shoes and of some men’s and children’s shoes.

This European standard specifies two methods of assessing the frictional properties of lining and insocks, irrespective of the material.

This document specifies two methods for the determination of the compression set characteristics of vulcanized and thermoplastic rubbers at low temperatures.

Method 1 derives from the methodology used in ISO 815-1. Method 2 uses a specified testing device, allowing to measure and record the test piece thickness during recovery. Due to the load applied during recovery in method 2, no correlation can be established between the results given by both methods.

NOTE When rubber is held under compression, physical or chemical changes that prevent the rubber returning to its original dimensions after release of the deforming force can occur. The result is a set, where the magnitude of which depends on the time and temperature of compression as well as on the time, temperature, and conditions of recovery. At low temperatures, changes resulting from the effects of glass hardening or crystallization become predominant and, since these effects are reversed by raising the temperature, it is necessary for all measurements to be undertaken at the test temperature.

This document takes a holistic approach to the accessibility of Information and Communications Technology (ICT) by combining guidance on implementing the accessibility of ICT systems (ICT accessibility) both at organizational and system levels.

This document gives guidelines for building and maintaining ICT systems (including products and services) that are accessible to diverse users (including users with disabilities and older people).

This document is applicable to all types of organizations. This document applies to the breadth of ICT systems and the results of convergent and emerging technologies within an organization, including but not limited to: information systems, intranet systems, Web sites, mobile and wearable applications, social media, and Internet of Things (IoT) systems.

It gives requirements and recommendations for organisations:

a) ensuring accessibility is considered in their policies or strategy by creating an organizational ICT accessibility policy;

b) embedding the consideration of accessibility decisions through the entire process of developing procuring, installing, operating and maintaining ICT systems, and documenting these choices;

c) justifying decisions on accessibility;

d) communicating the ICT system’s accessibility decisions to its users at launch, through creating and publishing its accessibility statement.

This document describes a procedure for the determination of ochratoxin A (OTA) in chilli, paprika, black and white pepper, nutmeg, spice mix, liquorice (root and extracts), cocoa and cocoa products by high performance liquid chromatography (HPLC) with immunoaffinity column clean-up and fluorescence detection.

This method has been validated in interlaboratory studies via the analysis of both naturally contaminated and spiked samples ranging from 1,0 μg/kg to 84,9 μg/kg for spices (paprika and chili [5], black and white pepper, nutmeg and spice mix [6]), ranging from 7,7 μg/kg to 96,8 μg/kg for liquorice [7] and ranging from 2,1 μg/kg to 26,3 μg/kg for cocoa and cocoa products [6].

For further information on the validation see Clause 9 and Annex B.

This document describes a procedure for the determination of ochratoxin A (OTA) in pork products specifically ham, pork based products (canned chopped pork) and pork liver using high performance liquid chromatography with fluorescence detection (HPLC-FLD).

The method has been validated for ochratoxin A with naturally contaminated ham, pork based products (canned chopped pork) and pork liver containing 0,5 μg/kg to 11 μg/kg [4, 5, 6].

Laboratory experiences have shown that this method is also applicable to pâté and kidney [4].

This document describes a procedure for the determination of phomopsins in lupin seeds and lupin-derived products based on liquid chromatography with tandem mass spectrometry (LC-MS/MS). Several phomopsins exist, i.e. phomopsin A, B, C and D, but the method only deals with the quantitative measurement of phomopsin A due to lack of commercially available analytical reference standards for the other phomopsins.

The method has been validated for phomopsin A in naturally contaminated lupin seeds, lupin flour and crisp bread at levels ranging from approximately 5 μg/kg to 60 μg/kg.

This document is a product specification, giving performance requirements for water overhead emergency safety body showers installed on industrial and logistic sites, (in combination with safety eyewashes and hand-held showers as well),

a) which are permanently connected to a water supply or

b) which are equipped with a store tank and optionally connected to an uninterrupted or a temporary water supply.

Emergency safety body showers using fluid other than water are not considered in this standard.

This standard also specifies requirements in respect of installation, adjustment and marking of the showers as well as operation and maintenance instructions to be given by the manufacturer.

NOTE 1 Plumbed-in body showers designed for laboratory facilities are dealt with in EN 15154-1.

NOTE 2 Water multiple nozzle body showers for sites other than laboratories are dealt with in prEN 15154-6.

NOTE 3 Attention is drawn to national regulations which may apply in respect of the installation and use of emergency safety showers