Document Number:
NL EN 12352 : 2011
Sector:
Construction Materials and Building
Status:
C
Production Year:
2011
Price:
35000.0000
This European Standard specifies the requirements for individual electrically operated light devices, called warning lights, emitting a continuous or regular intermittent light of a single colour which, by their colour and position alone, are used to warn, inform or guide road users. It specifies the requirements for visual, structural and operational performances and the relevant test methods to be used. These devices rely upon existing furniture to provide the mounting. This European Standard is not applicable to lighting devices which convey messages by additional means (e.g. variable message signs) or which convey a mandatory instruction (e.g. traffic signals) or which are covered by vehicle lighting regulations. This European Standard does not consider horizontal loads because it is the mounting to which they are fixed, which is not covered by this European Standard, which has to resist applied horizontal loads.
Document Number:
NL EN 12368 : 2011
Sector:
Construction Materials and Building
Status:
C
Production Year:
2011
Price:
35000.0000
This European Standard only applies to red, yellow and green signal lights for road traffic with 200 mm and 300 mm roundels. It defines the requirements for the visual, structural, environmental performances and testing of signal heads for pedestrian and road traffic use. Portable signal lights are specifically excluded from the scope of this European Standard.
Document Number:
NL EN 12676 1 : 2011
Sector:
Construction Materials and Building
Status:
C
Production Year:
2011
Price:
25000.0000
This Part of EN 12676 specifies the characteristics of an anti-glare system in terms of its optical effectiveness and of the mechanical performance of its elements. It gives a method for the determination of the optical performance of anti-glare systems by calculation. Requirements and recommendations for the design of anti-glare systems to minimize maintenance are also given. This Part of EN 12676 does not apply to : - types of anti-glare systems other than those attached to safety barriers; - regulatory characteristics which might be required to ensure that anti-glare systems are compatible with road signs; - specific requirements resulting from extreme environmental conditions experienced in some European countries.
Document Number:
NL EN 12966 1 : 2011
Sector:
Construction Materials and Building
Status:
C
Production Year:
2011
Price:
50000.0000
This document specifies requirements and test methods for new Variable Message Signs (VMS). VMS comprise two types, continuous and discontinuous signs: - continuous signs are those that are similar to fixed signs, the only difference being that by some electro-mechanical means they can show various messages. NOTE 1 For example rotating prism signs, roller blinds. - discontinuous signs create messages using individual elements that can be in one of two states (or more) and can thereby create various messages on the same sign face. NOTE 2 For example fibre optic signs, LED signs. This document covers the performance requirements for Variable Message Signs used for the instruction and guidance of road users on public and private land, including tunnels. In this document a number of different performance requirements (visual performance, EMC, environmental performance, etc) are covered, as well as durability. The EMC, safety and environmental requirements for both types of VMS are included in this document together with the visual performance for the discontinuous types VMS. The visual performance for continuous signs and discontinuous signs which are externally illuminated is covered by EN 12899-1. This document defines performance limits and a range of performance classes for both sign assemblies without vertical support and assemblies complete with vertical support. Not covered by this document are: a) sign gantries, cantilevers and foundations; b) portable and temporary VMS; c) signal heads; d) sizes and shapes of VMS messages; e) control units and monitoring units unless inside the test module.
Document Number:
NL EN 14388 : 2011
Sector:
Construction Materials and Building
Status:
C
Production Year:
2011
Price:
25000.0000
This document specifies the performance requirements and methods of evaluation for road traffic noise reducing devices. This document covers acoustic, non-acoustic and long term performance, but not aspects such as resistance to vandalism or requirements of visual appearance. This document covers products used for road traffic noise reduction made from any materials. This document does not cover road surfaces or the airborne sound insulation of houses. This document does not cover material specific characteristics necessary to meet the performance requirements of the standard. If existing, material specific standards should also apply in accordance with the specifications prescribed hereafter.
Document Number:
NL EN 13877 3 : 2011
Sector:
Construction Materials and Building
Status:
C
Production Year:
2011
Price:
25000.0000
This document specifies the requirements for dowels to be used in cast “in situ” concrete pavements for roads, airfields and other trafficked areas.
Document Number:
NL EN 14188 1 : 2011
Sector:
Construction Materials and Building
Status:
C
Production Year:
2011
Price:
35000.0000
This document specifies requirements for hot-applied normal and fuel resistant joint sealants to be used in roads, airfields and other trafficked areas. The specification also applies to hot-applied normal joint sealants in bituminous surfacing and between bituminous surfacing and concrete pavements.
Document Number:
NL EN 14188 2 : 2011
Sector:
Construction Materials and Building
Status:
C
Production Year:
2011
Price:
35000.0000
This document specifies the requirements for cold applied normal and fuel resistant joint sealants for concrete pavements to be used in roads, parking decks, bridge decks, airfields and other trafficked areas. This document does not cover the use in gasoline stations, jet fuel stations on airfields and the chemical industry.
Document Number:
NL ISO 9100 8 : 2011
Sector:
Packaging and Distribution of Goods
Status:
C
Production Year:
2011
Price:
25000.0000
This document specifies the dimensions of vacuum lug finishes with nominal sizes of 63, 66 and 70 mm regular for wide-mouth glass containers.
Document Number:
NL ISO 9058 : 2011
Sector:
Packaging and Distribution of Goods
Status:
C
Production Year:
2011
Price:
25000.0000
This International Standard specifies tolerances for glass bottles of circular cross-section and nominal capacity from to . NOTE This International Standard is based on CE.T.I.E [Centre technique international de l'embouteillage et du conditionnement (International Technical Centre for Bottling and Packaging), 112-114, rue La Boétie, 75008 Paris, France, http://www.cetie.org] data sheet DT 2 (1996) and EC Council Directive 75/107/EEC.
Document Number:
NL ISO 9100 11 : 2011
Sector:
Packaging and Distribution of Goods
Status:
C
Production Year:
2011
Price:
25000.0000
This document specifies the dimensions of a vacuum lug finish with a nominal size of 82 mm regular for widemouth glass containers.
Document Number:
NL ISO 90 1 : 2011
Sector:
Packaging and Distribution of Goods
Status:
C
Production Year:
2011
Price:
35000.0000
This patt of ISO 90 defines open-top cans and tan types, cross-sections, constructions, shapes, special features and capacities of such cans. lt specifies methods for determining Cross-sections and gross-lidded capacities. lt also specifies tolerantes on capacity and recommends an international designation.
Document Number:
NL EN 1797 : 2011
Sector:
Fluid systems and components for general use
Status:
C
Production Year:
2011
Price:
25000.0000
This European Standard specifies requirements for gas/materials compatibility for cryogenic vessels (such as chemical resistance) but it does not cover mechanical properties (e.g. for low temperature application). It gives guidance for compatibility with gases other than oxygen and it gives detailed requirements for oxygen and oxygen enriched atmosphere compatibility and defines the testing methods for establishing oxygen compatibility of materials (metallic and non-metallic) to be used for cryogenic vessels and associated equipment. It mainly deals with materials that are normally or could be in contact with liquid/gaseous oxygen e.g., materials for cryogenic vessels used for the storage and/or transport of liquid oxygen. It also deals with the materials which can be in contact with oxygen enriched environment e.g. insulating materials used for nitrogen, neon, hydrogen and helium cryogenic vessels in case of air condensation.
Document Number:
NL EN 12342 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
35000.0000
This European Standard specifies the basic requirements for breathing tubes and breathing tubing supplied to be cut to length, intended for use with anaesthetic apparatus and ventilators, humidifiers and nebulizers. It also applies to breathing tubes and Y-pieces supplied already assembled and to those supplied as components and assembled in accordance with the manufacturers' instructions. Provision is made for breathing tubes having ends incorporating adaptors with conical connectors (assembled ends) or with plain ends (either cylindrical or tapered). Breathing tubes for special purposes, such as those used with ventilators having special compliance requirements and coaxial lumen tubes, are outside the scope of this European Standard. Unless specified otherwise, the requirements of this European Standard apply equally to breathing tubes intended by the manufacturer for single use and those intended for re-use.
Document Number:
NL EN ISO 17510 1 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
50000.0000
IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment (add at the end of the Subclause 1.1): This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions. This part of ISO 17510 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates. Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510. This part of ISO 17510 does not apply to equipment covered by the scope of the ISO 10651 series, including: ⎯ ISO 10651-2:2004; ⎯ ISO 10651-3:1997; ⎯ ISO 10651-4:2002; ⎯ ISO 10651-5:2006; ⎯ ISO 10651-6:2004. This part of ISO 17510 does not apply to equipment covered by the scope of IEC 60601-2-12. ISO 17510 covers sleep apnoea breathing therapy equipment for patient use. ISO 17510-2 applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient. See also Figure AA.1.
Document Number:
NL EN ISO 17510 2 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
35000.0000
This part of ISO 17510 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient connection port of sleep apnoea breathing therapy equipment to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear. Sleep apnoea breathing therapy equipment is covered by ISO 17510-1. See Figure A.1 for typical elements of the two parts of ISO 17510. This part of ISO 17510 does not cover oral appliances.
Document Number:
NL EN 13348 : 2011
Sector:
Fluid systems and components for general use
Status:
C
Production Year:
2011
Price:
35000.0000
This European Standard specifies the requirements, sampling, test methods and conditions of delivery for copper tubes. It is applicable to seamless round copper tubes having an outside diameter from 6 mm up to and including 133 mm for pipeline systems under vacuum or for distributing the following medical gases intended to be used at operating pressures up to 2 000 kPa: oxygen, nitrous oxide, nitrogen, helium, carbon dioxide, xenon; medical air; specific mixtures of these above mentioned gases; air for driving surgical tools; anaesthetic gases and vapours.
Document Number:
NL EN 27440 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This International standard lays down the dimensions of two sizes of fitting features for detachable scalpel blades and the handles with wirich they are used.
Document Number:
NL EN 14683 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff to patients and (in certain situations vice-versa) during surgical procedures in operating theatres and other medical settings with similar requirements. This European Standard is not applicable to masks intended exclusively for the personal protection of staff. NOTE 1 Standards for masks for use as respiratory personal protective equipment are available. NOTE 2 Annex A provides information for the users of surgical masks.
Document Number:
NL ISO 7348 : 2011
Sector:
Packaging and Distribution of Goods
Status:
C
Production Year:
2011
Price:
50000.0000
This International Standard defines terms relating to the manufacture of glass Containers, to the materials used and to the processes and products associated with such manufacture. This International Standard deals with terms relating to the manufacture and processing of Containers, i.e. bottles and jars, made from soda-lime-silica glass by an automatic or semi- automatic process. lt does not concern terms relating to the manufacture of any other type of glass Container, such as laboratory beakers or flasks, or any item of domestic glassware, such as tumblers or decanters.
Document Number:
NL ISO 21067 : 2011
Sector:
Packaging and Distribution of Goods
Status:
C
Production Year:
2011
Price:
25000.0000
This International Standard specifies preferred terms and definitions related to packaging and materials handling, for use in international commerce. For packaging designed for the transport of dangerous goods, terms and definitions are given in the United Nations Recommendations on the Transport of Dangerous Goods [9].
Document Number:
NL ISO 8106 : 2011
Sector:
Packaging and Distribution of Goods
Status:
C
Production Year:
2011
Price:
25000.0000
This document specifies a gravimetric method for determining the capacity of glass containers and their compliance with specification limits.
Document Number:
NL ISO 186 : 2011
Sector:
Paper Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This International Standard specifies a method of obtaining a representative sample from a lot of paper or board, including solid and corrugated fibreboard (see ISO 4046), for testing to determine whether or not its average quality complies with set specifications. It defines the conditions which apply when sampling is carried out to resolve disputes between buyer and seller relating to a defined lot of paper or board, which has been or is being delivered. NOTE 1 If less than 50 % of the lot is available for sampling, then sampling in terms of this International Standard will be invalid in the absence of agreement to the contrary. The method is unsuitable for determining the variability within a lot. In cases where International Standards make reference to sampling according to this standard but where such sampling is impossible, impractical or inappropriate, and where no dispute is involved, guidance is given in normative annex A. NOTE 2 Information on the preparation of test pieces is given in the appropriate International Standards.
Document Number:
NL ISO 4046 5 : 2011
Sector:
Paper Technology
Status:
C
Production Year:
2011
Price:
35000.0000
This part of ISO 4046 defines terms related to properties of pulp, paper and board, in both English and French.
Document Number:
NL ISO 28219 : 2011
Sector:
Information Technology. Office Machines
Status:
C
Production Year:
2011
Price:
50000.0000
This International Standard ⎯ defines minimum requirements for identifying items; ⎯ provides guidelines for item marking with machine-readable symbols; ⎯ covers both labels and direct marking of items; ⎯ includes testing procedures for label adhesive characteristics and mark durability; ⎯ provides guidance for the formatting on the label of data presented in linear bar code, two-dimensional symbol or human readable form; ⎯ is intended for applications which include, but are not limited to, support of systems that automate the control of items during the processes of: ⎯ production; ⎯ inventory; ⎯ distribution; ⎯ field service; ⎯ point of sale; ⎯ repair, and ⎯ is intended to include, but it is not limited to, multiple industries including: ⎯ automotive; ⎯ aerospace; ⎯ chemical; ⎯ consumer items; ⎯ electronics; ⎯ health care; ⎯ marine; ⎯ rail; ⎯ telecommunications. NL ISO 28219:2011 ISO 28219:2009(E) 2 © ISO 2009 – All rights reserved The location and application method of the marking are not defined (these will be reviewed and agreed upon by suppliers and manufacturers and their trading partners before implementing this International Standard). This International Standard does not supersede or replace any applicable safety or regulatory marking or labeling requirements. This International Standard is meant to satisfy the minimum item marking requirements of numerous applications and industry groups and as such its applicability is to a wide range of industries, each of which may have specific implementation guidelines for it. This International Standard is to be applied in addition to any other mandated labeling direct-marking requirements. The labeling and direct marking requirement of this International Standard and other standards can be combined labeling into one label or marking area or appear as separate labels or marking areas. This International Standard uses the terms “part marking” and “item marking” interchangeably. Unless otherwise stated, this document will use the term “item marking” to describe both the labeling and direct part marking (DPM) of an item, where DPM includes, but is not limited to, altering (e.g. dot peen, laser etch, chemical etch) as well as additive type processes (e.g. ink jet, vacuum deposition). The purpose of this International Standard is to establish the machine-readable (linear, two dimensional, and composite symbols) and human readable content for direct marking and labeling of items, parts, and components. This International Standard provides a means for items, parts and components to be marked, and read in either fixtured or handheld scanning environments at any manufacturer’s facility and then read by customers purchasing items for subsequent manufacturing operations or for final end use. Intended applications include, but are not limited to supply chain applications, e.g. inventory, distribution, manufacturing, quality control, acquisition, transportation, supply, repair, and disposal. The figures are illustrative and not necessarily to scale or to the quality requirements specified in this International Standard.
Document Number:
NL ISO 7459 : 2011
Sector:
Packaging and Distribution of Goods
Status:
C
Production Year:
2011
Price:
25000.0000
This European Standard specifies test methods for determining the thermal shock resistance and thermal shock endurance of glass containers. This European Standard does not apply to the determination of properties of laboratory glassware (see ISO 718).
Document Number:
NL ISO 18153 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
35000.0000
This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. The following subjects are outside the scope of this standard: a) requirements for the design or selection of a reference measurement procedure; b) quantities involving mass of enzyme or immunoreactivity of enzymes; c) control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); d) control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; e) metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; f) properties involving nominal and ordinal scales
Document Number:
NL ISO 22870 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This International Standard gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this International Standard apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care. This International Standard can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters. Patient self-testing in a home or community setting is excluded, but elements of this International Standard can be applicable. NOTE Local, regional, and national regulations are to be taken into consideration.
Document Number:
NL ISO 17593 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
50000.0000
This International Standard specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use. This International Standard pertains solely to prothrombin time measuring systems used by individuals for monitoring their own vitamin-K antagonist therapy, and which report results as international normalized ratios (INR). This International Standard is applicable to manufacturers of such systems and those other organizations (e.g., regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems. This International Standard does not ⎯ pertain to in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist therapy used by physicians or healthcare providers, ⎯ provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, or ⎯ address the medical aspects of oral-anticoagulation therapy
Document Number:
NL ISO 20776 1 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
35000.0000
This part of ISO 20776 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization of bacteria as “susceptible” (S), “intermediate” (I), or “resistant” (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this part of ISO 20776, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in order
Document Number:
NL ISO TS 22367 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This Technical Specification characterizes the application of ISO 15189 as a system for reducing laboratory error and improving patient safety by applying the principles of risk management, with reference to examination aspects, especially to pre- and post-examination aspects, of the cycle of laboratory medical care. This Technical Specification proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189.
Document Number:
NL ISO TR 18112 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
50000.0000
This Technical Report summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use. Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use. Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included. Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison. IVD medical devices for self-testing are excluded.
Document Number:
NL ISO 20776 2 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This part of ISO 20776 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) and/or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. This part of ISO 20776 specifies requirements for AST devices (including diffusion test systems) and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. This part of ISO 20776 has been developed to guide manufacturers in the conduct of performance evaluation studies.
Document Number:
NL ISO 15193 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
35000.0000
La présente Norme internationale spécifie les exigences relatives au contenu d'une procédure de mesure de référence pour les dispositifs médicaux de diagnostic in vitro et les laboratoires d'analyses de biologie médicale. NOTE 1 Elle a pour but de permettre à un professionnel expérimenté, qui suit une procédure écrite selon la présente Norme internationale, d'espérer obtenir des résultats de mesure ayant un degré d'incertitude ne dépassant pas l'intervalle spécifié. La présente Norme internationale s'applique à des procédures de mesure de référence permettant d'obtenir des grandeurs différentielles ou proportionnelles. L'Annexe A fournit des informations relatives aux propriétés nominales et aux grandeurs ordinales. La présente Norme internationale est applicable à toute personne, tout organisme ou toute institution, impliqué dans l'une des branches de la biologie médicale, qui a l'intention de rédiger un document qui servira de procédure de mesure de référence. Des descriptions complètes de méthodes de mesure sont généralement publiées dans la littérature scientifique. Il convient que ces publications décrivent les méthodes de manière suffisamment détaillée pour qu'elles puissent être utilisées comme base d'une procédure de mesure documentée. NOTE 2 Dans la présente Norme internationale, le terme «mesurage international étalon» désigne un matériau étalon. Le terme «mesurage international étalon» est utilisé par l'OMS pour désigner les matériaux de référence.
Document Number:
NL ISO 15195 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
35000.0000
La présente Norme internationale décrit les exigences spécifiques requises à l'égard des laboratoires qui effectuent des mesures de référence dans le domaine de la biologie médicale. Les examens des propriétés conduisant à des résultats exprimés selon une échelle nominale ou ordinale ne sont pas concernés. La présente Norme internationale n'est pas applicable aux laboratoires de biologie médicale effectuant des analyses en routine. NOTE 1 Il relève de la responsabilité du laboratoire de satisfaire aux exigences réglementaires en vigueur en matière d'hygiène et de sécurité. NOTE 2 Les exigences pour les laboratoires de biologie médicale effectuant des analyses en routine sont spécifiées dans l'ISO 15189.
Document Number:
NL ISO 15198 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This International Standard describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. This International Standard applies to all in vitro diagnostic medical devices
Document Number:
NL ISO 17511 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
35000.0000
This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. External quality assessment (survey) samples, with proven commutability, whose values have been assigned by means of internationally agreed reference measurement systems or internationally agreed conventional reference measurement systems fall within the scope of this European Standard. This European Standard is not applicable to: a) control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); b) control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; c) correlation between results of two measurement procedures at the same metrological level, purporting to measure the same quantity, because such 'horizontal' correlation does not provide metrological traceability; d) calibration derived from correlation between the results of two measurement procedures at different metrological levels, but with quantities having analytes of different characteristics; e) metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; f) properties involving nominal scales, i.e. where no magnitude is involved (e.g. identification of blood cells).
Document Number:
NL ISO 18113 1 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
50000.0000
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.
Document Number:
NL ISO 18113 2 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to a) IVD instruments or equipment, b) IVD reagents for self-testing.
Document Number:
NL ISO 18113 3 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to: a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for self-testing.
Document Number:
NL ISO 18113 4 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment, b) IVD reagents for professional use.
Document Number:
NL ISO 18113 5 : 2011
Sector:
Health Care Technology
Status:
C
Production Year:
2011
Price:
25000.0000
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for professional use.
Document Number:
NL ISO 2444 : 2011
Sector:
Construction materials and building
Status:
C
Production Year:
2011
Price:
25000.0000
This International Standard defines terms used to describe building joints, their constituent Parts and their design in building construction.
Document Number:
NL ISO 2776 : 2011
Sector:
Construction materials and building
Status:
C
Production Year:
2011
Price:
15000.0000
This International Standard specifies the co-ordinating sizes for doorsets of all materials to be used in buildings, and which will fill co-ordinating spaces in dimensionally co-ordinated buildings. lt is based on the principles of modular Co-Ordination, and is in accordance with the ISO documents listed in the Foreword. NOTE - This International Standard gives a range of sizes limited to those which have been accepted by Member Bodies (national Standards may include additional sizes). Notice will be taken of experience in the use of all these sizes when considering a revision of this International Standard. 1 )
Document Number:
NL ISO 2777 : 2011
Sector:
Construction materials and building
Status:
C
Production Year:
2011
Price:
15000.0000
This International Standard specifies co-ordinating sizes for the length and width dimensions of rigid flat sheet boards used in building.
Document Number:
NL ISO 2848 : 2011
Sector:
Construction materials and building
Status:
C
Production Year:
2011
Price:
25000.0000
This International Standard specifies the aims of modular co- ordination and states the general principles and rules to be applied in determining the dimensions of buildings and the positioning and dimensioning of components, equipment and assemblies. 1)