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Thermal insulation products for building equipment and industrial installations - Factory made extruded polystyrene foam (XPS) products - Specification

This European Standard specifies the requirements for factory made extruded polystyrene foam products which are used for the thermal insulation of building equipment and industrial installations with an operating temperature in the range of approximately - 180 °C to + 75 °C. NOTE Below an operating temperature of - 50 °C, special tests regarding the suitability of the material in the intended application are advised (e.g. liquefaction of oxygen). Manufacturer's advice should be heeded in all cases. The products are manufactured in the form of faced or unfaced boards, pipe sections, segments and prefabricated ware. This standard describes product characteristics and includes procedures for testing, evaluation of conformity, marking and labelling. Products covered by this standard are also used in prefabricated thermal insulating systems and composite panels; the performance of systems incorporating these products is not covered. This standard does not specify the required level of a given property that shall be achieved by a product to demonstrate fitness for purpose in a particular application. The levels required for a given application can be found in regulations and invitations to tender. Products with a declared thermal conductivity greater than 0,060 W/(m.K) at a mean temperature of 10 °C are not covered by this standard. This standard does not cover products intended to be used for the insulation of the building structure nor for acoustical insulation.


Thermal insulation products for building equipment and industrial installations - Factory made rigid polyurethane foam (PUR) and polyisocyanurate foam (PIR) products - Specification

This European Standard specifies the requirements for factory made rigid polyurethane foam (PUR) and polyisocyanurate foam (PIR) products, with a closed cell content not less than 90 %, with or without facings, which are used for the thermal insulation of building equipment and industrial installations, with an operating temperature range of approximately, - 200 °C to + 200 °C. NOTE Below an operating temperature of - 50 °C, special tests regarding the suitability of the products in the intended application are advised (e.g. liquefaction of oxygen). Manufacturer's advice should be heeded in all cases. The products are manufactured in the form of blocks, faced or unfaced boards, pipe sections, segments and prefabricated ware. This standard describes product characteristics and includes procedures for testing, evaluation of conformity, marking and labelling. Products covered by this standard are also used in prefabricated thermal insulating systems and composite panels; the performance of systems incorporating these products is not covered. This standard does not specify the required level of a given property that shall be achieved by a product to demonstrate fitness for purpose in a particular application. The levels required for a given application are to be found in regulations and invitations to tender. Products with a declared thermal conductivity greater than 0,100 W/(m · K) at 10 °C are not covered by this standard. This standard does not cover products for in situ-insulation (spraying or dispensing) or products for the insulation of the building structure. This standard does not cover the following acoustical aspects: direct airborne sound insulation and impact noise transmission index.


Thermal insulation products for building equipment and industrial installations - Factory made products of expanded polystyrene (EPS) - Specification

This European Standard specifies the requirements for factory made products of expanded polystyrene which are used for the thermal insulation of building equipment and industrial installations with an operating temperature range of approximately - 180 °C to + 80 °C. Modified expanded polystyrene polymers with a higher temperature resistance are also covered by this standard. NOTE Below an operating temperature of - 50 °C, special tests regarding the suitability of the product in the intended application are advised (e.g. liquefaction of oxygen). Manufacturers’ advice should be heeded in all cases. The products are manufactured in the form of faced or unfaced boards, rolls, lags, pipe sections or other prefabricated ware. This standard describes product characteristics and includes procedures for testing, evaluation of conformity, marking and labelling. Products covered by this standard are also used in prefabricated thermal insulation systems and composite panels; the performance of systems incorporating these products is not covered. This standard does not specify the required level or class of a given property that shall be achieved by a product to demonstrate fitness for purpose in a particular application. The classes and levels required for a given application can be found in regulations and invitations to tender. Products with a declared thermal conductivity greater than 0,060 W/(m·K) at 10 °C are not covered by this standard. This standard does not cover products for in situ insulation (for loose fill or poured insulation) or products for the insulation of the building structure.


Plastics piping systems for hot and cold water installations -- Polypropylene (PP) -- Part 1: General

This part of ISO 15874 specifies the general aspects of polypropylene (PP) piping systems intended to be used for hot and cold water installations within buildings for the conveyance of water whether or not intended for human consumption (domestic systems), and for heating systems, under design pressures and temperatures according to the class of application (see Table 1). It covers a range of service conditions (classes of application), design pressures and pipe dimension classes. Values of TD, Tmax and Tmal in excess of those in Table 1 of this part of ISO 15874 do not apply. NOTE It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. It also specifies the test parameters for the test methods referred to in this part of ISO 15874. In conjunction with the other parts of ISO 15874, this part of ISO 15874 is a


Plastics piping systems for hot and cold water installations -- Polypropylene (PP) -- Part 2: Pipes

This part ISO 15874 specifies the requirements of pipes made from polypropylene (PP) for piping systems intended to be used for hot and cold water installations within buildings for the conveyance of water whether or not intended for human consumption (domestic systems) and for heating systems under operating pressures and temperatures appropriate to the class of application (see ISO 15874-1:2013, Table 1). This part of ISO 15874 covers a range of service conditions (application classes), design pressures and pipe dimension classes. For values of TD, Tmax and Tmal in excess of those in Table 1 of ISO 15874-1:2013 do not apply. NOTE 1 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. It also specifies the test parameters for the test methods referred to in this part of ISO 15874. In conjunction with the other parts of ISO 15874, this part of ISO 15874 is applicable to PP pipes, their joints and to joints with components of PP, other plastics and non-plastics materials intended to be used for hot and cold water installations. It is applicable to pipes with or without (a) barrier layer(s). NOTE 2 In the case of plastics pipes provided with a thin barrier layer, e.g. to prevent or greatly diminish the diffusion of gases and the transmission of light into or through the pipe wall, the design stress requirements are totally met by the base polymer (PP).


Plastics piping systems for hot and cold water installations -- Polypropylene (PP) -- Part 3: Fittings

This part of ISO 15874 specifies the characteristics of fittings for polypropylene (PP) piping systems intended to be used for hot and cold water installations within buildings for the conveyance of water, whether or not intended for human consumption (domestic systems) and for heating systems under design pressures and temperatures according to the class of application (see ISO 15874-1:2013, Table 1). It covers a range of service conditions (application classes) and design pressure classes. For values of TD, Tmax and Tmal in excess of those in Table 1 of ISO 15874-1:2013 do not apply. NOTE It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. It also specifies the parameters for the test methods referred to in this part of ISO 15874. In conjunction with the other parts of ISO 15874, this part of ISO 15874 is applicable to fittings made from PP and to fittings made from other materials which are intended to be fitted to pipes conforming to ISO 15874-2 for hot and cold water installations, whereby the joints conform to the requirements of ISO 15874-5. This part of ISO 15874 is applicable to fittings of the following types: — socket fusion fittings; — electro fusion fittings; — mechanical fittings; — fittings with incorporated inserts. It is also applicable to fittings made from alternative materials which when fitted to pipes conforming to ISO 15874-2, conform to the requirements of ISO 15874-5.


Plastics piping systems for hot and cold water installations -- Polypropylene (PP) -- Part 5: Fitness for purpose of the system

This part of ISO 15874 specifies the characteristics of the fitness for purpose of polypropylene (PP) piping systems, intended to be used for hot and cold water installations within buildings for the conveyance of water, whether or not intended for human consumption (domestic systems) and for heating systems, under design pressures and temperatures according to the class of application (see Table 1 of ISO 15874-1:2013). This part of ISO 15874 covers a range of service conditions (classes of application) and design pressure classes. For values of TD, Tmax and Tmal in excess of those in Table 1 of ISO 15874-1:2013 does not apply. NOTE It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. It also specifies the test parameters for the test methods referred to in this part of ISO 15874. In conjunction with the other parts of ISO 15874, it is applicable to PP pipes, fittings, their joints and to joints with components of other plastics and non-plastics materials intended to be used for hot and cold water installations.


Plastics piping systems for hot and cold water installations -- Chlorinated poly(vinyl chloride) (PVC-C) -- Part 1: General

This part of ISO 15877 specifies the general requirements of chlorinated poly(vinyl chloride) (PVC-C) piping systems intended to be used for hot and cold water installations within buildings for the conveyance of water, whether or not intended for human consumption (domestic systems) and for heating systems, under design pressures and temperatures appropriate to the class of application (see Table 1). This part of ISO 15877 covers a range of service conditions (classes of application), design pressures and pipe dimension classes. For values of TD, Tmax and Tmal in excess of those in Table 1, this part of ISO 15877 does not apply. NOTE It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. It also specifies the test parameters for the test methods referred to in this part of ISO 15877. In conjunction with the other parts of ISO 15877, it is applicable to PVC-C pipes and fittings, their joints and joints with components of other plastics and non-plastics materials intended to be used for hot and cold water installations.


Plastics piping systems for hot and cold water installations -- Chlorinated poly(vinyl chloride) (PVC-C) -- Part 2: Pipes

This part of ISO 15877 specifies the requirements of pipes made from chlorinated poly(vinyl chloride) (PVC-C) for piping systems intended to be used for hot and cold water installations within buildings for the conveyance of water, whether or not intended for human consumption (domestic systems) and for heating systems, under design pressures and temperatures appropriate to the class of application (see Table 1 of ISO 15877-1:2009). This part of ISO 15877 covers a range of service conditions (application classes), design pressures and pipe series. For values of TD, Tmax and Tmal in excess of those in Table 1 of ISO 15877-1:2009, this part of ISO 15877 does not apply. NOTE It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. It also specifies the test parameters for the test methods referred to in this part of ISO 15877. In conjunction with the other parts of ISO 15877, it is applicable to PVC-C pipes, their joints and joints with components of PVC-C, other plastics and non-plastics materials intended to be used for hot and cold water installations.


Plastics piping systems for hot and cold water installations -- Chlorinated poly(vinyl chloride) (PVC-C) -- Part 3: Fittings

This part of ISO 15877 specifies the characteristics of fittings made from chlorinated poly(vinyl chloride) (PVCC) for piping systems intended to be used for hot and cold water installations within buildings for the conveyance of water, whether or not intended for human consumption (domestic systems) and for heating systems under design pressures and temperatures according to the class of application (see Table 1 of ISO 15877-1:2009). This part of ISO 15877 covers a range of service conditions (application classes) and design pressure classes. For values of TD, Tmax and Tmal in excess of those in Table 1 of ISO 15877-1:2009, this part of ISO 15877 does not apply. NOTE 1 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. It also specifies the parameters for the test methods referred to in this part of ISO 15877. In conjunction with the other parts of ISO 15877, it is applicable to PVC-C fittings, their joints and joints with components of PVC-C, other plastics and non-plastics materials intended to be used for hot and cold water installations. This part of ISO 15877 is applicable to fittings of the following types: ⎯ fittings for solvent cement joints; ⎯ mechanical fittings; ⎯ fittings with incorporated inserts. NOTE 2 Fittings made from PVC-C are manufactured by injection-moulding.


Plastics piping systems for hot and cold water installations -- Chlorinated poly(vinyl chloride) (PVC-C) -- Part 5: Fitness for purpose of the system

This part of ISO 15877 specifies the characteristics of the fitness for purpose of chlorinated poly(vinyl chloride) (PVC-C) piping systems, intended to be used for hot and cold water installations within buildings for the conveyance of water, whether or not intended for human consumption, (domestic systems) and for heating systems, under design pressures and temperatures according to the class of application (see Table 1 of ISO 15877-1:2009). This part of ISO 15877 covers a range of service conditions (application classes) and design pressure classes. For values of TD, Tmax and Tmal in excess of those in Table 1 of ISO 15877-1:2009, this part of ISO 15877 does not apply. NOTE It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. It also specifies the test parameters for the test methods referred to in this part of ISO 15877. In conjunction with the other parts of ISO 15877, it is applicable to PVC-C pipes, fittings, their joints and joints with components of other plastics and non-plastics materials intended to be used for hot and cold water installations.


Plastics piping systems for hot and cold water installations -- Chlorinated poly(vinyl chloride) (PVC-C) -- Part 7: Guidance for the assessment of conformity

This Technical Specification gives guidance for the assessment of conformity included in the manufacturer's quality plan as part of his/her quality system. This Technical Specification includes: a) provisions for materials, components, joints and assemblies given in the applicable part(s) of ISO 15877; b) provisions for the manufacturer's quality system, which can conform to ISO 9001[2]; c) definitions and procedures applied if certification is involved; in which case, the certification body can be accredited to ISO/IEC Guide 65[5] or ISO/IEC 17021[3], as applicable. In conjunction with the other parts of ISO 15877, this Technical Specification is applicable to chlorinated poly(vinyl chloride) (PVC-C) piping systems intended to be used for hot and cold water installations within buildings for the conveyance of water, whether or not intended for human consumption (domestic systems), under design pressures and temperatures appropriate to the class of application (see Table 1 of ISO15877-1:2009).


Multilayer piping systems for hot and cold water installations inside buildings -- Part 1: General

This part of ISO 21003 specifies the general aspects of multilayer piping systems intended to be used for hot and cold water installations inside buildings for the conveyance of water — whether or not the water is intended for human consumption (domestic systems) or heating systems — under specified design pressures and temperatures appropriate to the class of application (see Table 1). ISO 21003 is a reference product standard (see 3.4.3). It is applicable to multilayer pipes, fittings, their joints, and also to joints with components made of other plastics and non-plastics materials intended to be used for hot and cold water installations. This part of ISO 21003 is intended for use only in conjunction with all the other parts of ISO 21003. ISO 21003 applies only to multilayer pipes with their inner layer made of plastics. It covers a range of service conditions (application classes) and design pressures. It is not applicable for values of design temperature, TD, maximum design temperature, Tmax, and malfunction temperature, Tmal, in excess of those in Table 1. NOTE 1 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. The polymeric materials used for the stress-designed layers are the following: polybutylene (PB), polyethylene of raised temperature resistance (PE-RT), crosslinked polyethylene (PE-X), polypropylene (PP) and chlorinated poly(vinyl chloride) (PVC-C). The PE-X used shall be fully crosslinked and shall comply with the requirements of the relevant reference product standard (ISO 15875). NOTE 2 For the purposes of ISO 21003, crosslinked polyethylene (PE-X) as well as adhesives are considered as thermoplastic materials. Solid-wall pipes with thin outer layers (applied as protection layers or barrier layers, for instance) are not covered by ISO 21003 but are specified in the Amendments to ISO 15874-2, ISO 15875-2 and ISO 15876-2. The total thickness of such outer layers, including the thickness of the adhesives used, shall be u 0,4 mm.


Multilayer piping systems for hot and cold water installations inside buildings -- Part 2: Pipes

This part of ISO 21003 specifies the characteristics of pipes for multilayer piping systems intended to be used for hot and cold water installations inside buildings for the conveyance of water — whether or not the water is intended for human consumption (domestic systems) or heating systems — under specified design pressures and temperatures appropriate to the class of application (see Table 1 of ISO 21003-1:2008). It also specifies the test parameters for the test methods referred to in this part of ISO 21003. ISO 21003 is a reference product standard. It is applicable to multilayer pipes, fittings, their joints, and also to joints with components made of other plastics and non-plastics materials intended to be used for hot and cold water installations. This part of ISO 21003 is intended for use only in conjunction with all the other parts of ISO 21003. ISO 21003 covers a range of service conditions (application classes) and design pressures. It is not applicable for values of design temperature, TD, maximum design temperature, Tmax, and malfunction temperature, Tmal, in excess of those in Table 1 of ISO 21003-1:2008. NOTE 1 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. The polymeric materials used for the stress-designed layers are the following: polybutylene (PB), polyethylene of raised temperature resistance (PE-RT), crosslinked polyethylene (PE-X), polypropylene (PP) and chlorinated poly(vinyl chloride) (PVC-C). The PE-X used shall be fully crosslinked and shall comply with the requirements of the relevant reference product standard (ISO 15875). NOTE 2 For the purposes of ISO 21003, crosslinked polyethylene (PE-X) as well as adhesives are considered as thermoplastic materials. Solid-wall pipes with thin outer layers (applied as protection layers or barrier layers, for instance) are not covered by ISO 21003 but are specified in the Amendments to ISO 15874-2, ISO 15875-2 and ISO 15876-2. The total thickness of such outer layers, including the thickness of the adhesives used, shall be u 0,4 mm.


Multilayer piping systems for hot and cold water installations inside buildings -- Part 3: Fittings

This part of ISO 21003 specifies the characteristics of fittings for multilayer piping systems intended to be used for hot and cold water installations inside buildings for the conveyance of water — whether or not the water is intended for human consumption (domestic systems) or for heating systems — under specified design pressures and temperatures appropriate to the class of application (see Table 1 of ISO 21003-1:2008). It also specifies the test parameters for the test methods referred to in this part of ISO 21003. ISO 21003 is a reference product standard. It is applicable to multilayer pipes, fittings, their joints, and also to joints with components made of other plastics and non-plastics materials intended to be used for hot and cold water installations. This part of ISO 21003 is intended for use only in conjunction with all the other parts of ISO 21003. This part of ISO 21003 covers fusion, solvent-cemented and mechanical fittings for a range of service conditions (application classes) and design pressures. It is not applicable for values of design temperature, TD, maximum design temperature, Tmax, and malfunction temperature, Tmal, in excess of those in Table 1 of ISO 21003-1:2008. NOTE 1 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. The polymeric materials used for the stress-designed layers are the following: polybutylene (PB), polyethylene of raised temperature resistance (PE-RT), crosslinked polyethylene (PE-X), polypropylene (PP) and chlorinated poly(vinyl chloride) (PVC-C). The PE-X used shall be fully crosslinked and shall comply with the requirements of the relevant reference product standard (ISO 15875). NOTE 2 For the purposes of ISO 21003, crosslinked polyethylene (PE-X) as well as adhesives are considered as thermoplastic materials.


Multilayer piping systems for hot and cold water installations inside buildings -- Part 5: Fitness for purpose of the system

This part of ISO 21003 specifies the characteristics for the fitness for purpose of multilayer piping systems intended to be used for hot and cold water installations inside buildings for the conveyance of water — whether or not the water is intended for human consumption (domestic systems) or for heating systems — under specified design pressures and temperatures appropriate to the class of application (see Table 1 of ISO 21003:2008). It also specifies the test parameters for the test methods referred to in this part of ISO 21003. ISO 21003 is a reference product standard. It is applicable to multilayer pipes, fittings, their joints, and also to joints with components made of other plastics and non-plastics materials intended to be used for hot and cold water installations. This part of ISO 21003 is intended for use only in conjunction with all the other parts of ISO 21003. ISO 21003 covers a range of service conditions (application classes) and design pressures. It is not applicable for values of design temperature, TD, maximum design temperature, Tmax, and malfunction temperature, Tmal, in excess of those in Table 1 of ISO 21003-1:2008. NOTE 1 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes. The polymeric materials used for the stress-designed layers are the following: polybutylene (PB), polyethylene of raised temperature resistance (PE-RT), crosslinked polyethylene (PE-X), polypropylene (PP) and chlorinated poly(vinyl chloride) (PVC-C). The PE-X used shall be fully crosslinked and shall comply with the requirements of the relevant reference product standard (ISO 15875). NOTE 2 For the purposes of this ISO 21003, crosslinked polyethylene (PE-X) as well as adhesives are considered as thermoplastic materials.


Multilayer piping systems for hot and cold water installations inside buildings -- Part 7: Guidance for the assessment of conformity

This Technical Specification is applicable, in conjunction with the other parts of ISO 21003 (see Foreword), to multilayer piping systems intended to be used for hot and cold water installations inside buildings for the conveyance of water — whether or not the water is intended for human consumption (domestic systems) or for heating systems — under specified design pressures and temperatures appropriate to the class of application (see Table 1 of ISO 21003-1:2008). It gives guidance for the assessment of conformity, to be included in the manufacturer's quality plan as part of the quality system. It includes: ⎯ requirements for materials, components, joints and assemblies given in the applicable part(s) of ISO 21003; ⎯ requirements for the manufacturer's quality system (e.g. ISO 9001 [2]); ⎯ definitions and procedures to be used if third-party certification is involved. NOTE If third-party certification is involved, it is recommended that the certification body be accredited to ISO/IEC Guide 65 [3] or ISO/IEC 17021 [4], as applicable.


Laboratory glassware -- Thermo-alcoholometers and alcohol-thermohydrometers

This International Standard specifies alcoholometers incorporating a thermometer (thermo-alcoholometers) and alcoholthermohydrometers, suitable for general alcoholometric purposes. The details specified are, as far as alcoholometer and hydrometer specifications are concerned, in conformity with ISO 387. NOTE - The scale of alcoholometers is adjusted to allow direct readings of alcohol contents of alcohol-water mixtures. The scale of alcohol-hydrometers is graduated in density units (for example kglm$ and their nominal range is particularly adapted to the requirements of alcoholometry.


Glass alcoholometers and alcohol hydrometers not incorporating a thermometer

This International Standard sets forth the requirements for three different types of glass instrument, not incorporating a thermometer, suitable for the accurate determination of the ethanol content of simple mixtures of ethanol and water, namely - tYPe 1 : alcoholometers graduated in percentage of ethanol by volume at 20 ‘C; - type 2 : alcoholometers graduated in percentage of ethanol by mass; - type 3 : alcohol hydrometers graduated in units of density (kilograms per cubic metre) at 20 “C. Two classes of accuracy are specified for types 1 and 2 and one class for type 3. Alcoholometers and alcohol hydrometers with an incorporated thermometer are dealt with in ISO 4805’ ).


Laboratory apparatus -- Vocabulary relating to apparatus made essentially from glass, porcelain or vitreous silica -- Part 1: Names for items of apparatus

This part of ISO 4791 lists the names of items of laboratory apparatus, made essentially from glass, porcelain or vitreous silica, together with items of equipment, made from other materials, which are commonly used in association with such apparatus. A vocabulary of technical terms, with their definitions and applicable to the manufacture, adjustment and use of such laboratory apparatus, will be issued as Part 2. The purpose of the vocabulary is to provide an aid to translators and readers of scientific Iiterature. Because of the need to translate older documents, certain items of equipment now regarded as obsolete have been included. NOTE - In addition to terms used in the three official ISO languages (English, French and Russian), this part of ISO 4791 gives the equivalent terms in German; these have been included at the request of Technical Committee ISO/TC 48 and are published under the responsibility of the member body for the Federal Republic of Germany (DIN). However, only the terms given in the official languages tan be considered as ISO terms.


Laboratory glassware -- Volumetric instruments -- Methods for testing of capacity and for use

This International Standard provides methods for the testing, calibration and use of volumetric instruments made from glass in order to obtain the best accuracy in use. NOTE Testing is the process by which the conformity of the individual volumetric instrument with the appropriate standard is determined, culminating in the determination of its error of measurement at one or more points. The International Standards for the individual volumetric instruments include clauses on the definition of capacity; these clauses describe the method of manipulation in sufficient detail to define the capacity without ambiguity. This International Standard contains supplementary information. The procedures are applicable to volumetric instruments with nominal capacities in the range of 0,1 ml to 10 000 ml. These include: single-volume pipettes (see ISO 648) without subdivisions; graduated measuring pipettes and dilution pipettes, with partial or complete subdivisions (see ISO 835); burettes (see ISO 385); volumetric flasks (see ISO 1042); and graduated measuring cylinders (see ISO 4788). The procedures are not recommended for testing of volumetric instruments with capacities below 0,1 ml such as micro-glassware. This International Standard does not deal specifically with pyknometers as specified in ISO 3507. However, the procedures specified below for the determination of volume of glassware can, for the most part, also be followed for the calibration of pyknometers.


Chemical disinfectants and antiseptics - Hygienic handwash - Test method and requirements (phase 2/step 2)

This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handwash reduces the release of transient microbial flora on hands when used to wash the artificially contaminated hands of volunteers. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handwash for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:  in hospitals, in community medical facilities and in dental institutions,  in clinics of schools, of kindergartens and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 2 This method corresponds to a phase 2, step 2 test.


Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)

This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of transient microbial flora on hands when rubbed onto the artificially contaminated hands of volunteers. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handrub for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:  in hospitals, in community medical facilities and in dental institutions,  in clinics of schools, of kindergartens and of nursing homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 2 This method corresponds to a phase 2, step 2 test.


Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requireme

This document specifies a test method and the minimum requirements for fungicidal or yeasticidal 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. This document applies to products that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included: a) processing, distribution and retailing of: 1) food of animal origin: 2) food of vegetable origin:  milk and milk products;  beverages;  meat and meat products;  fruits, vegetables and derivatives (including sugar, distillery ...);  fish, seafood, and related products;  flour, milling and baking;  eggs and egg products;  animal feeds;  animal feeds;  etc. b) institutional and domestic areas:  catering establishments;  public areas;  public transports;  schools;  nurseries;  shops;  sports rooms;  waste containers (bins ...);  hotels;  dwellings;  clinically non-sensitive areas of hospitals;  offices;  etc. c) other industrial areas:  packaging material;  biotechnology (yeast, proteins, enzymes, ...);  pharmaceutical;  cosmetics and toiletries;  textiles;  space industry, computer industry;  etc. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. 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 1 test.


Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2,

This European Standard 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. This document applies to products that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included: a) processing, distribution and retailing of: 1) food of animal origin:  milk and milk products;  meat and meat products;  fish, seafood, and related products;  eggs and egg products;  animal feeds;  etc. 2) food of vegetable origin:  beverages;  fruits, vegetables and derivatives (including sugar, distillery, etc.);  flour, milling and baking;  animal feeds;  etc. b) institutional and domestic areas:  catering establishments;  public areas;  public transports;  schools;  nurseries;  shops;  sports rooms;  waste containers (bins, etc.);  hotels;  dwellings;  clinically non sensitive areas of hospitals;  offices;  etc.


Safety rules for the construction and installation of lifts - Special lifts for the transport of persons and goods - Part 40: Stairlifts and inclined lifting platforms intended for persons with impaired mobility

1.1 This European Standard deals with safety requirements for construction, manufacturing, installation, maintenance and dismantling of electrically operated stairlifts (chair, standing platform and wheelchair platform) affixed to a building structure, moving in an inclined plane and intended for use by persons with impaired mobility:  travelling over a stair or an accessible inclined surface;  intended for use by one person;  whose carriage is directly retained and guided by a guide rail or rails;  supported or sustained by rope (5.4.4), rack and pinion (5.4.5), chain (5.4.6), screw and nut (5.4.7), friction traction drive (5.4.8), and guided rope and ball (5.4.9). 1.2 The standard identifies hazards as listed in Clause 4 which arise during the various phases in the life of such equipment and describes methods for the elimination or reduction of these hazards when used as intended by the manufacturer. 1.3 This European standard does not specify the additional requirements for:  operation in severe conditions (e.g. extreme climates, strong magnetic fields);  lightning protection;  operation subject to special rules (e.g. potentially explosive atmospheres);  handling of materials the nature of which could lead to dangerous situations;  use of energy systems other than electricity;  hazards occurring during manufacture;  earthquakes, flooding, fire;  type C wheelchairs as defined in EN 12183 and/or EN 12184;  evacuation during a fire;  stairlifts for goods only;  concrete, hardcore, timber or other foundation or building arrangement;  design of anchorage bolts to the supporting structure. NOTE For the actual type of machinery, noise is not considered a significant nor relevant hazard. 1.4 This document is not applicable to power operated stairlifts which are manufactured before the date of publication of this document by CEN


Safety rules for the construction and installation of lifts - Existing lifts - Part 82: Rules for the improvement of the accessibility of existing lifts for persons including persons with disability

1.1 This European Standard provides rules on how to apply EN 81-70 referred to in EN 81-80:2003, 5.2.1 [4] to existing lifts to improve their accessibility for persons including persons with disability. 1.2 This European Standard applies to permanently installed lifts serving defined landing levels, having a car designed for the transportation of persons or persons and goods and moving between guide rails inclined not more than 15° to the vertical


Sustainability in building construction — Sustainability indicators — Part 1: Framework for the development of indicators and a core set of indicators for buildings

This part of ISO 21929 establishes a core set of indicators to take into account in the use and development of sustainability indicators for assessing the sustainability performance of new or existing buildings, related to their design, construction, operation, maintenance, refurbishment and end of life. Together, the core set of indicators provides measures to express the contribution of a building(s) to sustainability and sustainable development. These indicators represent aspects of buildings that impact on areas of protection related to sustainability and sustainable development. The object of consideration in this part of ISO 21929 is a building or a group of buildings and the external works within the site (curtilage). This part of ISO 21929 follows the principles set out in ISO 15392 and, where appropriate, is intended for use in conjunction with, and following the principles set out in, ISO 26000, ISO 14040 and the family of International Standards that includes ISO 14020, ISO 14021, ISO 14024 and ISO 14025. Where deviation occurs or where more specific requirements are stated, this part of ISO 21929 takes precedence. This part of ISO 21929  adapts general sustainability principles for buildings;  includes a framework for developing sustainability indicators for use in the assessment of economic, environmental and social impacts of buildings;  determines the aspects for consideration when defining a core set of sustainability indicators for buildings;  establishes a core set of indicators;  describes how to use sustainability indicators;  gives rules for establishing a system of indicators. This part of ISO 21929 does not give guidelines for the weighting of indicators or the aggregation of assessment results. NOTE In addition to the core set of indicators defined in this part of ISO 21929, the use of other sustainability indicators can be relevant in the local context when assessing or setting targets for a building's contribution to sustainability. Examples and information about these other sustainability indicators are given in Annex A.


Safety rules for the construction and installation of lifts - Lifts for the transport of persons and goods - Part 20: Passenger and goods passenger lifts

1.1 This standard specifies the safety rules for permanently installed new passenger or goods passenger lifts, with traction, positive or hydraulic drive, serving defined landing levels, having a car designed for the transportation of persons or persons and goods, suspended by ropes, chains or jacks and moving between guide rails inclined not more than 15° to the vertical. 1.2 In addition to the requirements of this standard, supplementary requirements shall be considered in special cases (use of lifts by persons with disabilities, in case of fire, potentially explosive atmosphere, extreme climate conditions, seismic conditions, transporting dangerous goods, etc.). 1.3 This standard does not cover: a) lifts with: 1) drive systems other than those stated in 1.1; 2) rated speed ≤ 0,15 m/s; b) hydraulic lifts: 1) with a rated speed exceeding 1 m/s; 2) where the setting of the pressure relief valve (5.9.3.5.3) exceeds 50 MPa; c) new passenger or goods passenger lifts in existing buildings 2) where in some circumstances due to limitations enforced by building constraints, some requirements of EN 81-20 cannot be met and EN 81-21 should be considered; d) lifting appliances, such as paternosters, mine lifts, theatrical lifts, appliances with automatic caging, skips, lifts and hoists for building and public works sites, ships' hoists, platforms for exploration or drilling at sea, construction and maintenance appliances or lifts in wind turbines; e) important modifications (see Annex C) to a lift installed before this standard is brought into application; f) safety during operations of transport, erection, repairs, and dismantling of lifts. However, this standard may usefully be taken as a basis. Noise and vibrations are not dealt with in this standard as they are not found at levels which could be considered as harmful with regard to the safe use and maintenance of the lift (see also 0.4.2). 1.4 This standard is not applicable to passenger and goods passenger lifts, which are installed before the date of its publication.


Safety rules for the construction and installation of lifts - Examinations and tests - Part 50: Design rules, calculations, examinations and tests of lift components

This European Standard specifies the design rules, calculations, examinations and tests of lift components which are referred to by other standards used for the design of passenger lifts, goods passenger lifts, goods only lifts, and other similar types of lifting appliances.


Safety rules for the construction and installations of lifts - Particular applications for passenger and good passengers lifts - Part 70: Accessibility to lifts for persons including persons with disability

This European Standard specifies the minimum requirements for the safe and independent access and use of lifts by persons, including persons with the disabilities mentioned in annex B, Table B.1. This European Standard covers lifts with minimum car dimensions according to Table 1 and provided with car doors and landing doors constructed as automatic power operated horizontally sliding doors. This European Standard considers accessibility to lifts for persons using wheelchairs with maximum overall dimensions defined in EN 12183:1999 and EN 12184:1999. This European Standard also deals with the additional technical requirements to minimise the hazards listed in clause 4 that arise during the operation of lifts intended to be accessible to disabled users. NOTE This standard can be used as guidance for upgrading existing lifts in line with the recommendation of the European Commission dated 8th of June, 1995 (95/216/EC) concerning improvements to safety of existing lifts.


Plastic Piping Systems for Water Supply, and for drainage and sewerage under pressure- Polyethylene (PE) - Part 1: General

This European Standard specifies the general aspects of polyethylene (PE) pressure piping systems (mains and service pipes) for buried or above ground applications, intended for the conveyance of water for human consumption, raw water prior to treatment, drainage and sewerage under pressure, vacuum sewer systems, and water for other purposes. NOTE 1 For PE components intended for the conveyance of water intended for human consumption and raw water prior to treatment attention is drawn to Clause 5 of this European Standard. Components manufactured for water for other purposes, drainage and sewerage may not be suitable for water supply for human consumption. It also specifies the test parameters for the test methods referred to in this standard. In conjunction with Parts 2 to 5 of EN 12201, it is applicable to PE pipes, fittings, valves, their joints and to joints with components of other materials intended to be used under the following conditions: a) allowable operating pressure, PFA, up to 25 bar ); b) an operating temperature of 20 °C as a reference temperature; c) buried in the ground; d) sea outfalls; e) laid in water; f) above ground, including pipes suspended below bridges. NOTE 2 For applications operating at constant temperatures greater than 20 °C and up to 40 °C, see Annex A. EN 12201 (all parts) covers a range of allowable operating pressures and gives requirements concerning colours and additives. NOTE 3 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national guidance or regulations and installation practices or codes.


Plastic Piping Systems for Water Supply, and for drainage and sewerage under pressure - Polyethylene (PE) - Part 2: Pipes

This part of EN 12201 specifies the characteristics of pipes made from polyethylene (PE 100, PE 80 and PE 40) for buried and above ground applications, intended for the conveyance of water for human consumption, raw water prior to treatment, drainage and sewerage under pressure, vacuum sewer systems, and water for other purposes. NOTE 1 For PE components intended for the conveyance of water for human consumption and raw water prior to treatment attention is drawn to 5.3 of this European Standard. Components manufactured for water for general purposes, drainage and sewerage may not be suitable for water supply for human consumption. It also specifies the test parameters for the test methods referred to in this standard. In conjunction with Part 1 and Parts 3 to 5 of EN 12201, it is applicable to PE pipes, their joints and to joints with components of PE and other materials intended to be used under the following conditions: a) allowable operating pressure, PFA, up to 25 bar ); b) an operating temperature of 20 °C as a reference temperature; c) buried in the ground; d) sea outfalls; e) laid in water; f) above ground, including pipes suspended below bridges. NOTE 2 For applications operating at constant temperatures greater than 20 °C and up to 40 °C, see Annex A of EN 12201-1:2011. NOTE 3 Pipes constructions including barrier layers are not covered by this document. EN 12201 covers a range of allowable operating pressures and gives requirements concerning colours and additives. It covers three types of pipe: - PE pipes (outside diameter dn) including any identification stripes; - PE pipes with co-extruded layers on either or both the outside and/or inside of the pipe (total outside diameter dn) as specified in Annex B, where all layers have the same MRS rating; - PE pipes (outside diameter dn) with a peelable, contiguous thermoplastics additional layer on the outside of the pipe (‘coated pipe’) as specified in Annex C. NOTE 4 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national guidance or regulations and installation practices or codes. NOTE 5 Assessment of the resistance to slow crack growth of the PE pipe compound used for the manufacture of products to this document is required in accordance with Table 2 of EN 12201-1:2011.


Plastic Piping Systems for Water Supply, and for drainage and sewerage under pressure - Polyethylene (PE) - Part 3: Fittings

This !European Standard" specifies the characteristics of fittings made from polyethylene (PE 100 and PE 80) intended for the conveyance of water for human consumption, raw water prior to treatment, drainage and sewerage under pressure, vacuum sewer systems, and water for other purposes. NOTE 1 For PE components intended for the conveyance of water for human consumption and raw water prior to treatment, attention is drawn to 5.6 of this part of EN 12201. Components manufactured for water for other purposes, drainage and sewerage may not be suitable for water supply for human consumption. It also specifies the test parameters for the test methods referred to in this standard. In conjunction with Parts 1, 2 ,4 and 5 of EN 12201, it is applicable to PE fittings, their joints and to joints with components of PE and other materials intended to be used under the following conditions: a) allowable operating pressure, PFA, up to 25 bar; b) an operating temperature of 20 °C as a reference temperature; c) buried in the ground; d) sea outfalls; e) laid in water; f) above ground, including pipes suspended below bridges. NOTE 2 For applications operating at constant temperature greater than 20 °C and up to 40 °C, see Annex A of EN 12201-1:2011. EN 12201 (all parts) covers a range of allowable operating pressures and gives requirements concerning colours and additives. NOTE 3 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national guidance or regulations and installation practices or codes. These fittings can be of the following types: a) fusion fittings; 1) electrofusion fittings; 2) spigot end fittings (for butt fusion using heated tools and electrofusion socket fusion); 3) socket fusion fittings (see Annex A); b) mechanical fittings; 1) compression fittings; 2) flanged fittings; c) fabricated fittings (see Annex B).


Plastic Piping Systems for Water Supply, and for drainage and sewerage under pressure–Polyethylene (PE) – Part 5: Fitness for purpose of the system

This European Standard specifies the characteristics of the fitness for purpose of the assembled piping systems intended for the conveyance of water intended for human consumption, raw water prior to treatment, drainage and sewerage under pressure, vacuum sewer systems, and water for other purposes. It also specifies the method of preparation of test piece joints, and the tests to be carried out on these joints for assessing the fitness for purpose of the system under normal and extreme conditions. NOTE 1 For PE components intended for the conveyance of water for human consumption and raw water prior to treatment attention is drawn to the introduction of this part of EN 12201. Components manufactured for water for other purposes may not be suitable for water supply for human consumption. It also specifies the test parameters for the test methods referred to in this standard. In conjunction with Parts 1 to 4 of EN 12201 it is applicable to PE pipes, fittings, valves, their joints and to joints with components of other materials intended to be used under the following conditions: a) allowable operating pressure, PFA, up to 25 bar 1) ; b) an operating temperature of 20 °C as a reference temperature. c) buried in the ground; d) sea outfalls; e) laid in water; f) above ground, including pipes suspended below bridges. NOTE 2 For applications operating at constant temperatures greater than 20 °C up to 40 °C, see Annex A of EN 12201-1:2011. EN 12201 (all parts) covers a range of allowable operating pressures and gives requirements concerning colours and additives. NOTE 3 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national guidance or regulations and installation practices or codes.


Plastics piping systems for water supply, and for drainage and sewerage under pressure - Polyethylene (PE) - Part 7: Guidance for the assessment of conformity

This part of EN 12201 gives guidance for the assessment of conformity of compounds, products, joints and assemblies in accordance with the applicable part(s) of EN 12201 intended to be included in the manufacturer’s quality plan as part of the quality management system and for the establishment of certification procedures. It is recommended that the quality management system conforms to or is no less stringent than the relevant requirements to EN ISO 9001 [1]. NOTE 1 If certification is involved, the certification and inspection body is preferably compliant with EN ISO/IEC 17065 [5], EN ISO/IEC 17021 [3] or EN ISO/IEC 17020 [2], as applicable. In conjunction with Parts 1 to 5 of EN 12201 (see Foreword) this document is applicable to polyethylene (PE) plastics piping systems for water supply, and for drainage and sewerage under pressure. It is applicable to PE pipes, fittings, and valves, their joints and to joints with components of other materials intended to be used under the following conditions: a) allowable operating pressure, PFA, up to 25 bar1); b) an operating temperature of 20 °C as a reference temperature; c) buried in the ground; d) sea outfalls; e) laid in water; f) above ground, including pipes suspended below bridges. NOTE 2 For applications operating at constant temperature greater than 20 °C and up to 40 °C, see EN 12201-1:2011, Annex A. NOTE 3 It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national guidance or regulations and installation practices or codes.


Gas cylinders - Transportable Refillable Welded Steel Cylinders for Liquefied Petroleum Gas (LPG): Design and Construction

This International Standard specifies minimum requirements concerning material, design, construction and workmanship, procedure and test at manufacture of transportable refillable welded steel liquefied petroleum gas (LPG) cylinders of water capacity up to and including 150 l, exposed to ambient temperatures.


Plastic materials and articles intended to come into contact with foodstuffs

1.1 This Standard establishes specific requirements for the manufacture and marketing of plastic materials and articles: a. Intended to come into contact with food; or b. Already in contact with food; or c. Which can reasonably be expected to come into contact with food


Table Olives

تهدف هذه المواصفة القياسية إلى تحديد المتطلبات والشروط الواجب توافرها في زيتون المائدة المعد للاستهلاك المباشر. كما تطبق هذه المواصفة القياسية على الزيتون المعروض بشكل سائب والمعد لإعادة التعبئة في عبوات صغيرة


Gas cylinders -- Fitting of valves to gas cylinders

This International Standard specifies the procedures to be followed when connecting cylinder valves to gas cylinders. It specifically applies to all valve and cylinder combinations connected with ISO screw threads as specified in ISO 10920 and ISO 11363-1. It defines routines for inspection and preparation prior to valving for both taper and parallel screw threads. Torque values are given in Annex A for steel and aluminium gas cylinders including composite cylinders with steel or aluminium boss. NOTE The procedures and practices specified in this International Standard can be beneficially applied to other valve to cylinder screw thread connection systems. ISO/TR 11364[4] lists the valve to gas cylinder threads in use worldwide. It gives details of the thread identification codes, whether the threads are interchangeable with ISO threads and if the taping procedure and torque values specified in this International Standard can be used. ISO/TR 11364[4] gives clear guidance for the method and torque for all listed inlet threads, which are not interchangeable.


Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables

This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.


Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion a) with extracts of a device, and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters


Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how this document is applied, are also included in the informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993. NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).


Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products

This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This part of ISO 10993 considers both non-resorbable and resorbable materials. This part of ISO 10993 is not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE 1 Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this part of ISO 10993, such degradation products can evoke a biological response and thus need to undergo biological evaluation as described in other parts of ISO 10993. b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly. NOTE 2 This part of ISO 10993 can be applied to the degradation of materials used in any kind of product that falls within the definition of “medical device” in ISO 10993-1, even if such products are subject to different regulations from those applying to medical devices, e.g. the scaffold in a tissue engineered medical product, or a carrier matrix to deliver drugs or biologics


Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. This part of ISO 10993 includes: a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; b) details of in vivo (irritation and sensitization) test procedures; c) key factors for the interpretation of the results. Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin


Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO 10993 addresses the following: — test sample selection; — selection of representative portions from a device; — test sample preparation; — experimental controls; — selection of, and requirements, for reference materials; — preparation of extracts. This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.


Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices

This part of ISO 10993 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This part of ISO 10993 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. This part of ISO 10993 considers only nonresorbable polymers. Similar but appropriately modified procedures may be applicable for resorbable polymers. This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity. NOTE An informative text discussing environmental stress cracking (ESC) of polymers is included as a potential aid to the design of degradation studies (see Annex B). The biological activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1, ISO 10993-16 and ISO 10993-17. Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identified or given preference. No specific requirements for acceptable levels of degradation products are provided in this part of ISO 10993.


Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device; the assessment of the biological safety of the medical device.


Road restraint systems - Part 5: Product requirements and evaluation of conformity for vehicle restraint systems

This European Standard specifies requirements for evaluation of conformity of the following vehicle restraint systems: a) safety barriers; b) crash cushions; c) terminals (will be effective when ENV 1317-4 becomes an EN); d) transitions (will be effective when ENV 1317-4 becomes an EN); e) vehicle / pedestrian parapets (only for the vehicle restraint function). Pedestrian parapet requirements are not covered in this document. Requirements for the evaluation of durability with respect to weathering are included in this document. Requirements for other forms of durability (e.g. marine environment, sand abrasion) are not included. Temporary barriers are not within the scope of this document.


Road marking materials - Drop on materials - Glass beads, antiskid aggregates and mixtures of the two

This European Standard specifies the requirements applicable to glass beads, anti-skid aggregates, and the mixture of the two, which are applied as drop-on materials on road markings products (i.e. paints, cold plastics and thermoplastics). Glass beads and/or anti-skid aggregates, or their mixture, applied during the process of manufacturing other road marking products are not covered by this European Standard