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Document Number: NL ISO 3947 : 2008

This International Standard specifies a spectrophotometric method for the determination of the total phosphorus content of starch, including derivatives and by-products, in which the expected content, calculated as phosphorus (P), does not exceed 5 % (m/m).

Starches, native or modified- Determination of total fat content

Document Number: NL EN 1873 : 2008

This International Standard specifies a method for the determination of the total fat content of starches, native or modified, of which the expected total fat content is less than 1,5 % (m/m).

Prefabricated accessories for roofing - Individual roof lights of plastics- Product specification and test methods

Document Number: NL ISO 2479 : 2008

This European Standard specifies requirements for rooflights made of plastic materials (e.g. GF-UP, PC, PMMA, PVC) and rooflights with upstands made of e.g. GF-UP, PVC, steel, aluminium or wood for installation in roofs. These rooflights serve the purpose of introducing daylight. This European Standard applies to rooflights with a rectangular or circular ground plan (see Figures 1 and 2), with an opening span (width) or diameter not larger than 2,5 m and an opening length not larger than 3,0 m in roof pitches up to 25°. This document does not cover rooflights which contribute to the load-bearing or stiffness of the roof itself. This European Standard applies to rooflights and rooflights with upstand, where a single manufacturer provides all components of the rooflight with upstand, which are bought in a single purchase. This European Standard applies to rooflights with one or several translucent parts. Rooflights may be opened by means of opening devices in one or more parts for ventilation. The possible additional functions of day to day ventilation, smoke and heat ventilation e.g. in case of fire in accordance with EN 12101 2, roof access, and/ or slinging point e.g. in accordance with EN 795 are outside the scope of this document. This European Standard does not include calculations with regard to construction, design requirements and installation techniques. NOTE Guidelines for safety, application, use and maintenance of individual rooflights are presented in Annex A.

Sodium chloride for industrial use- Determination of matter insoluble in water or in acid and preparation of principal for other determinations

Document Number: NL ISO 2480 : 2008

This International Standard specifies a method for determining insoluble matter in sodium chloride for industrial use. It also describes the preparation of principal solutions for other determinations. NOTE— Sodium chloride for industrial use may contain components that are only very slightly soluble or dissolve very slowly in water. Insoluble substances in sodium chloride for industrial use shall therefore be defined by the conditions of determination described in this International Standard. These conditions reproduce those normally used during the handling of salt for industrial use. The object is not to dissolve all the impurities but only those of interest to users.

Sodium chloride for industrial use- Determination of sulphate content- Barium sulphate gravimetric method

Document Number: NL ISO 2481 : 2008

This International Standard specifies a gravimetric method for the determination of sulphate content of sodium chloride for industrial use.

Sodium chloride for industrial use- Determination of halogens, expressed as chlorine- Mercurimetric method

Document Number: NL ISO 2482 : 2008

This International Standard specifies a mercurimetric method for the determination of halogens expressed as chlorine, in sodium chloride for industrial use.

Sodium chloride for industrial use- Determination of calcium and magnesium contents- EDTA complexometry methods

Document Number: NL ISO 2483 : 2008

This International Standard specifies complexometric methods for determining the calcium and magnesium contents in sodium chloride for industrial use.

Sodium chloride for industrial use- Determination of the loss of mass at 110ºC

Document Number: NL ISO 6406 : 2008

This International Standard specifies a method for the determination of the loss of mass at 110°C (conventional moisture) of sodium chloride for industrial use.

Gas cylinders -- Seamless steel gas cylinders -- Periodic inspection and testing

Sector: Fluid systems and components for general use

Document Number: NL ISO 14245 : 2008

ISO 6406:2005 deals with seamless steel transportable gas cylinders (single or those that comprise a bundle) intended for compressed and liquefied gases under pressure, of water capacity from 0,5 l up to 150 l; it also applies, as far as practical, to cylinders of less than 0,5 l water capacity. ISO 6406:2005 specifies the requirements for periodic inspection and testing to verify the integrity of such gas cylinders to be re-introduced into service for a further period of time. ISO 6406:2005 does not apply to periodic inspection and testing of acetylene cylinders or composite cylinders with steel liners.

Gas cylinders -- Specifications and testing of LPG cylinder valves -- Self-closing

Sector: Fluid systems and components for general use

Document Number: NL ISO 4796 1 : 2008

This International Standard specifies the requirements for design, specification and type testing for dedicated LPG self-closing cylinder valves specifically for use with transportable refillable LPG cylinders from 0,5 l up to 150 l water capacity. It includes references to associated equipment for vapour or liquid service. NOTE Annex B gives recommendations for production testing and inspection. This International Standard does not apply to fixed automotive installations.

Laboratory glassware - Bottles-Part1: Screw -neck Bottles

Document Number: NL ISO 4796 2 : 2008

This part of ISO 4796 specifies a series of screw-neck bottles suitable for the storage of fluid liquid and solid chemicals and reagents in general laboratory use. These bottles with nominal volumes ranging from 25 ml to 20 000 ml are also suitable for the preparation and storage of microbiological growth media.

Laboratory glassware - Bottles-Part2: Conical neck Bottles

Document Number: NL ISO 4796 3 : 2008

This part of ISO 4796 specifies a series of bottles with a conical, wide or narrow neck with or without ground joints, suitable for the storage of liquid and solid chemicals and reagents in general laboratory use.

Laboratory glassware - Bottles-Part3: Aspirator Bottles

Document Number: NL ISO 4797 : 2008

This part of ISO 4796 specifies a series of aspirator bottles with a screw neck or with a conical neck suitable for the delivery of liquid chemicals and reagents in general laboratory use.

Laboratory glassware -Boiling flasks with conical ground joints

Document Number: NL ISO 4798 : 2008

This International Standard specifies requirements for an internationally acceptable series of boiling flasks with conical ground joints for general laboratory purposes.

Laboratory glassware -Filter funnels

Document Number: NL ISO 4799 : 2008

This International Standard specifies requirements and dimensions for glass filter funnels suitable for general laboratory purposes, fitting together with other general-use glassware such as boiling flasks and volumetric flasks. NOTE — Annex A lists additional International Standards for other general-purpose laboratory glassware.

Laboratory glassware -Condensers

Document Number: NL ISO 4800 : 2008

This International Standard specifies details for an internationally acceptable series of glass condensers suitable for general use in laboratories.

Laboratory glassware -Separating funnels and dropping funnels

Document Number: NL ISO 4803 : 2008

This International Standard specifies details of an internationally acceptable series of glass separating funnels and dropping funnels suitable for general use in laboratories.

Laboratory glassware -Borosilicate glass tubing

Document Number: NL ISO 4832 : 2008

This International Standard specifies requirements for an internationally acceptable range of borosilicate glass tubing for laboratory apparatus.

Microbiology of food and animal feeding stuffs - Horizontal method for the enumeration of coliforms - Colony-count technique

Document Number: NL ISO 4833 : 2008

This International Standard gives general guidelines for the enumeration of coliforms. It is applicable to — products intended for human consumption and for the feeding of animals, and — environmental samples in the area of food production and food handling, by means of the technique of counting colonies after incubation on a solid medium at 30 °C or at °C. NOTE The temperature is subject to agreement between the parties concerned. In the case of milk and milk products, the temperature of incubation is °C. This technique is recommended when the number of colonies sought is expected to be more than 100 per millilitre or per gram of the test sample.

Microbiology of food and animal feeding stuffs — Horizontal method for the enumeration of microorganisms — Colony-count technique at 30 °C

Document Number: NL ISO 5377 : 2008

This International Standard specifies a horizontal method for the enumeration of microorganisms, by counting the colonies growing in a solid medium after aerobic incubation at 30 °C. Subject to the limitations discussed in the introduction, this International Standard is applicable to products intended for human consumption or the feeding of animals. The applicability of this International Standard to the examination of certain fermented food and animal feeding stuffs is limited. For the examination of fermented food and animal feeding stuffs, other media and/or incubation conditions might be more appropriate.

Starch hydrolysis products -- Determination of reducing power and dextrose equivalent -- Lane and Eynon constant titre method

Document Number: NL ISO 5378 : 2008

This International Standard specifies a Lane and Eynon constant titre method for the determination of the reducing power and dextrose equivalent of all starch hydrolysis products.

Starches and derived products -- Determination of nitrogen content by the Kjeldahl method -- Spectrophotometric method

Document Number: NL ISO 5379 : 2008

This International Standard specifies a spectrophotometric method for the determination, by the Kjeldahl method, of the nitrogen content of starch and its derived products whose presumed nitrogen content is less than 0,025 % (m/m).1) NOTE — In starches and their derived products to which nitrogenous materials have not been added, the nitrogen is present essentially in the form of protein and/or amino acids.

Starch and derived products- Determination of sulfur dioxide content- Acidimetric method and nephelometric method

Document Number: NL ISO 5381 : 2008

This International Standard specifies two methods (an acidimetric method and a nephelometric method) for the determination of the sulfur dioxide content of starches and derived products.

Starch hydrolysis products -- Determination of water content -- Modified Karl Fischer method

Document Number: NL ISO 5498 : 2008

This International Standard specifies a method for the determination of the water content of starch hydrolysis products.

Agricultural food products- Determination of crude fiber content- General method

Document Number: NL ISO 5537 : 2008

This International Standard specifies a conventional method for the determination of the crude fibre content of agricultural food products.

Dried milk - Determination of moisture content (Reference method)

Document Number: NL ISO 5549 : 2008

This International Standard specifies a method for the determination of the moisture content of all types of dried milk.

Caseins and caseinates - Determination of Protein content (Reference method)

Document Number: NL ISO 5809 : 2008

This International Standard specif ies a reference method for the determination of the Protein content of caseins and caseinates, excluding those containing ammonium caseinate or other ammonium compounds, or other nitrogenous non- Protein compounds.

Starches and derived products -- Determination of sulphated ash

Document Number: NL ISO 5810 : 2008

This International Standard specifies a method for the determination of sulphated ash in starches and derived products.

Starches and derived products -- Determination of chloride content -- Potentiometric method

Document Number: NL ISO 4788 : 2008

This International Standard specifies a potentiometric method for the determination of the chloride content of starches and derived products, except cationic starches and amyloids soluble when cold, the viscosity of these being too high to allow for correct stirring when titrating.

Laboratory glassware -- Graduated measuring cylinders

Sector: Metrology and Measurement. Physical Phenomena

Document Number: NL ISO 13485 : 2008

This International Standard specifies dimensions, material and constructional and metrological requirements of graduated measuring cylinders of tall form (Type 1a and Type 1b) and of squat form (Type 2). All types are suitable for general laboratory use. The specifications in this International Standard are in conformity with the principles of design and construction of volumetric glassware given in ISO 384.

Medical devices - quality management systems Requirements for regulatory purposes

Document Number: NL EN 1974 : 2008

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by this International Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes. If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this International Standard reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

Food Processing machinery. Slicing machines. Safety and hygiene requirements

Document Number: NL EN 13570 : 2008

1.1 This European Standard specifies the safety and hygiene requirements for the design and manufacture of slicing machines which are fitted with power driven circular cutting blade of more than 150 mm in diameter, with a reciprocating feed carriage and are transportable. These types of slicing machines are intended to be used in shops, restaurants, supermarkets, canteens etc. Industrial slicers are excluded. They are normally used in meat and sausage processing plants; they are not intended to be transportable and are permanently placed in position. It covers all significant hazards at such machines, as identified by risk assessment (see EN 1050), which are listed in 4 of this Standard. It applies when such machines are operated under the intended use as defined in 3.12 of EN 292-1:1991 and stated in the instruction handbook (see 7.2), included cleaning, dismantling of removable parts and changing the blade. NOTE If the machine is not used under the above conditions, the manufacturer should, when informed of such a situation, check by a new risk analysis that the preventative measures remain valid. Noise and vibration are not considered to be significant hazards for these machines. 1.2 This Standard covers the following types of slicing machines: - Horizontal feed slicers (manual - see figure 1 - or automatic - see figure 13 - ); - Gravity feed slicers (manual - see figure 2 - or automatic). Slicing machines consist of a base, a blade, a blade cover, a blade guard, a blade sharpener, a gauge plate (a guard plate for automatic slicers), a product holder, a reciprocating carriage, a product pusher and electrical control components. Slicing machines can be equipped with: - Clamping device, - Stacker, - Discharge conveyor. This Standard applies to machines which are manufactured after the date of issue of this Standard.

Food Processing machinery. Mixers and mixing machines. Safety and hygiene requirements

Document Number: NL EN 13870 : 2008

1.1 This European Standard specifies safety and hygiene requirements to minimise the hazards which can arise during the commissioning, the use and the maintenance of mixing machines and their accessories intended to be used in sausage kitchens and industrial operations. This European Standard deals with all significant hazards, hazardous situations and events relevant to mixing machines, when they are used !as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer (see Clause 4)". This European standard is not applicable to mixing machines which are manufactured before the date of publication of this European Standard by CEN. 1.2 This European Standard covers the following types of mixing machines: - Mixing machines with a tilting container, one or several mixing shafts - Mixing machines with a stationary mixing container, front face or bottom discharge opening - Mixing machines with a container and loading device - Mixing machines with a container, mixing shaft(s), screw conveyor and loading device The mixing machines are constructed of a machine frame, a trough-shaped mixing container, one or several mixing shafts, an associated drive and electrical, hydraulic and pneumatic components, depending on machine type. The mixing shaft can be equipped with wings, screws, rods, paddles or the like. Mixing machines may be equipped e. g. with - cover over the top of the mixing container, - pipe connections for gases, steam, water or vacuum, - protective hood over the front face discharge opening, - lifting devices for mixing shaft, - loading device, - screw conveyor at the discharge opening. KEY 1 cover 2 mixing container 3 mixing shaft 4 front-face discharge opening 5 bottom discharge opening Figure 1 - Components of a mixing machine 1.3 Intended use The fresh or frozen meat, meat product, meat pieces or fish, salt, spices and other additives are loaded into the mixing container by hand or by means of a loa

Food Processing machinery. Chop cutting machines. Safety and hygiene requirements

Document Number: NL EN 13776 : 2008

This document covers chop cutting machines and accessories. The extent, to which hazards are covered, is indicated in this document. 1.1 This document specifies requirements for design and manufacture of chop cutting machines. The machines covered by this document are used for continuous portioning of fresh, smoked or frozen meat with and without bones or of similar products by separation by means of a blade. This document deals with all significant hazards, hazardous situations and events relevant to machines, Appliances and machinery, when they are used as intended and under the conditions foreseen by the Manufacturer (see Clause 4). This document deals with the hazards which can arise during commissioning, operation, maintenance and decommissioning of the machine. The document is not dealing with the specific hazards of loading devices. This document is not applicable to chop cutting machines which are manufactured before the date of Publication of this document by CEN. 1.2 This document covers the following types of machines: chop cutting machines with a discharge chute chop cutting machines with a discharge trough 1.3 Machine construction Chop cutting machines are constructed of a machine frame, a feed trough with an automatic forward feed device, a blade housing, a blade, a removal unit, associated drives, electrical, hydraulic and pneumatic components, depending on machine type. Chop cutting machines in the scope of this document may be equipped with: a feed conveyor belt in longitudinal- and lateral axis; a removal conveyor belt; a transfer trolley for the blade. 1.4 Intended use The intended use (as defined in EN 12100-1:2003, 3.22) of chop cutting machines as dealt with in this document is described in 1.1. The material to be cut is fed either manually or by means of a loading device into the feed trough. The material to be cut is fed to the blade by means of the automatic forward feed device. The product falls via the discharge chute into a trolley or into a discharge trough which may be equipped with a removal conveyor belt. Although it should be advised against, the standard, taking into account practice, deals with the hazards due to cleaning with pressurized water.

Filling and discharge procedures for LPG road tankers

Sector: Road Vehicles Engineering

Document Number: NL ISO 5739 : 2008

This European Standard specifies filling, discharge and emergency procedures for road tankers equipped in accordance with EN 12252 used for the transportation of liquefied petroleum gas (LPG). This European Standard does not apply to "batteries of receptacles".

Caseins and caseinates - Determination of contents of scorched particles and of extraneous matter

Document Number: NL ISO 4142 : 2008

This International Standard specifies a method for the determination of the contents of scorched particles and of extraneous matter in caseins and caseinates.

Laboratory glassware -- Test tubes

Sector: Metrology and Measurement. Physical Phenomena

Document Number: NL ISO 4256 : 2008

This International Standard specifies a range of test tubes, suitable for general laboratory use, fabricated from borosilicate, neutral or soda/lime glass, which are designated Type I, Type II and Type III respectively.

Liquefied petroleum gases -- Determination of gauge vapour pressure -- LPG method

Sector: Petroleum and related Technologies

Document Number: NL EN 14782 : 2008

This International Standard describes a method for the determination of gauge vapour pressures of liquefied petroleum gas products (see clause 3) at temperatures within the approximate range of 35 °C to 70 °C. NOTES 1 Information on the vapour pressure of liquefied petroleum gases is required for the selection of properly designed storage vessels, shipping containers and customer utilization equipment, to ensure the safe handling of these products, and to ensure that maximum operating design pressures are not exceeded under the foreseen ambient operating conditions. 2 The vapour pressure of liquefied petroleum gases is an indirect measure of the lowest temperature at which initial vaporization can be expected to occur. It may also be considered to be an indirect indication of the most volatile constituent present in the product.

Self-supporting metal sheet for roofing, external cladding and internal lining - Product specification and requirements

Document Number: NL EN 14783 : 2008

This European Standard specifies the terminology, requirements and test methods for factory made self-supporting metal sheets and tiles (for non-structural applications) delivered in the form of manufactured pieces for roofing and wall cladding and lining. This standard also covers ceiling (including internal metal sheet) and soffit applications and cassettes (see Figure 1). This standard covers self-supporting copper, zinc, steel, aluminium and stainless steel sheet with or without coatings, e.g. metallic, organic, inorganic or multi-layer (see Annex A). A moisture retaining layer may be present on the reverse side of the product. This standard also includes rules for marking, labelling and evaluation of conformity. This standard does not cover products for structural purposes, i.e. it does not cover products intended to contribute to the global or partial stability of the building structure by providing racking resistance or resistance to permanent static loads (excluding self-weight of the metal sheet). Requirements concerning acoustical and thermal insulation properties are not considered in this standard. This standard does not include calculation or design requirements with regards to the works, installation techniques or the performance of the installed products

Fully supported metal sheet and strip for roofing, external cladding and internal lining - Product specification and requirements

Document Number: NL EN 13969 : 2008

This European Standard specifies the terminology, requirements and test methods for metal coil, strip, and flat sheets and factory made pieces intended for fully supported applications in roofing and wall cladding or lining. It does not apply to products manufactured on site. This European Standard covers fully-supported aluminium, copper, lead, steel, stainless steel and zinc products with or without coatings, e.g. metallic, organic, inorganic or multi-layer (see Annex A). This European Standard also includes rules for marking, labelling and evaluation of conformity. Requirements concerning acoustical and insulation properties are not considered in this European Standard. This European Standard does not include calculation or design requirements with regards to the works, installation techniques or the performance of the installed products.

Flexible sheets for waterproofing - Bitumen damp proof sheets including bitumen basement tanking sheets - Definitions and characteristics

Document Number: NL EN 13970 : 2008

This document specifies definitions and characteristics of flexible reinforced bitumen sheets for which the intended use is as damp proofing for buildings, including basement tanking. It specifies the requirements and test methods and provides for the evaluation of conformity of the products with the requirements of this standard.

Flexible sheets for waterproofing - Bitumen water vapour control layers - Definitions and characteristics

Document Number: NL ISO 14602 : 2008

This document specifies definitions and characteristics of flexible reinforced bitumen sheets for which the intended use is as water vapour control layers for buildings. It specifies the requirements and test methods and provides for the evaluation of conformity of the products with the requirements of this document.

Non-active surgical implants – Implants for osteosynthesis – Particular requirements

Document Number: NL ISO 14630 : 2008

This International Standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter referred to as implants. In addition to ISO 14630, this International Standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer

Non-active surgical implants – General requirements

Document Number: NL ISO 14155 1 : 2008

This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referred to in level 2 and level 3 standards. NOTE This International Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, might be appropriate to help ensure that the implant achieves its intended performance.

Clinical investigation of medical devices for human subjects -- Part 1: General requirements

Document Number: NL ISO 14155 2 : 2008

This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to  protect human subjects,  ensure the scientific conduct of the clinical investigation,  assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. This part of ISO 14155 a) specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device, b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. This part of ISO 14155 is not applicable to in vitro diagnostic medical devices

Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans

Document Number: NL ISO 14160 : 2008

This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation. This Standard does not apply to in vitro diagnostic medical devices

Sterilization of single use medical devices incorporating materials of animal origin – Validation and routine control of sterilization by liquid chemical sterilants

Document Number: NL EN 14180 : 2008

This International Standard specifies requirements for the development, validation, process control and monitoring of the sterilization, by the use of liquid chemical sterilants, of single-use medical devices comprising, in whole or in part,materials of animal origin. This International Standard does not apply to material of human origin. This International Standard does not describe a quality assurance system for the control of all stages of manufacture. NOTE 1 Attention is drawn to the standards for quality systems (see ISO 9001 and ISO 13485 or ISO 9002 and ISO 13488) which can be used in the control of all stages of manufacture including the sterilization process. This International Standard does not describe tests to establish the effects of any chosen sterilization method upon the fitness for use of the medical device. NOTE 2 Such testing is a crucial part of the design and development of a medical device. This International Standard does not describe methods for the validation of the inactivation of viruses. NOTE 3 In developing a method for processing medical devices containing materials of animal origin, consideration of the effects of liquid chemical sterilization on potential viral contaminants will also be necessary because of the source of materials used in the manufacture of these particular medical devices. The importance of validation of viral inactivation for processes within the scope of this International Standard is recognized. This aspect is excluded from this International Standard; a separate European Standard is in preparation (EN 12442-3). NOTE 4 Liquid chemical sterilants traditionally employed to sterilize animal tissues in medical devices may not be effective in inactivating the causative agents of transmissable spongiform encephalopathies such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this International Standard should not be assumed to demonstrate inactivation of infective agents of this type. This International Standard does not cover the level of residual sterilant within medical devices. NOTE 5 ISO 14538 is concerned with this issue.

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers-Requirements and testing

Document Number: NL ISO 14408 : 2008

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: -for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

Tracheal tubes designed for laser surgery – Requirements for marking and accompanying information

Document Number: NL EN 14511 1 : 2008

This International Standard specifies marking, labelling, and information to be supplied by the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist ignition by a laser

Air conditioners, liquid chilling packages and heat pumps with electrically driven compressors for space heating and cooling— Part 1: Terms and definitions

Sector: Fluid systems and components for general use