11.100.01 - Laboratory medicine in general
ICS 11.100.01 Details
Laboratory medicine in general
Médecine de laboratoire en général
Laboratorijska medicina na splošno
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This document establishes requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions.
It outlines the general principles and assessment criteria by which an LDT shall be designed, developed, characterized, manufactured, validated (analytically and clinically) and monitored for internal use by medical laboratories.
The scope includes regulatory authority approved IVD medical devices that are used in a manner differing from approved labelling or instructions for use for that device (e.g. use of a sample type not included in the intended use, use of instruments or reagents not included in the labelling).
While this document follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within specific disciplines of the medical laboratory nor specific technology platforms.
This document does not specify requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-IVD purposes. However, the concepts presented in this document can also be useful for these laboratories.
This document does not apply to the design, development and industrial production of commercially used IVD medical devices.
- Standard43 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides requirements and recommendations for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document.
- Technical specification33 pagesEnglish languagesale 15% off
- Technical specification38 pagesSpanish languagesale 15% off
This document provides guidance to anatomic pathology (AP) laboratories on implementing a management system to meet requirements for quality and competence of ISO 15189. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification31 pagesEnglish languagesale 15% off
- Technical specification34 pagesSpanish languagesale 15% off
This document defines the requirements for competence of individuals who provide advice, guidance, and assurance on processes to identify, assess, control, and monitor the risks associated with hazardous biological materials in a laboratory or other related organization that handles, stores, transports, or disposes of biological materials that can be potentially hazardous for people, animals, plants and the environment.
- Technical specification62 pagesEnglish languagesale 15% off
- Technical specification68 pagesSpanish languagesale 15% off
- Standard1 pageEnglish languagesale 15% off
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- Standard1 pageFrench languagesale 15% off
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment4 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and good practice recommendations for the collection and transport of samples intended for medical laboratory examinations. This document is applicable to medical laboratories and service providers, which can be independent from the medical laboratory, involved in laboratory pre-examination processes that include the examination request, patient preparation and identification, sample collection and transport. It can also be applicable to some biobanks. This document does not apply to blood and blood products intended for transfusion, e.g. red blood cells, platelets, fresh frozen plasma, but can cover the collection and transport of donor samples for testing. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard42 pagesEnglish languagesale 15% off
- Standard47 pagesFrench languagesale 15% off
This document specifies requirements and tests for glass Petri dishes intended for general laboratory purposes and microbiological work.
- Standard7 pagesEnglish languagesale 15% off
- Standard7 pagesFrench languagesale 15% off
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard72 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation102 pagesSlovenian and English languagesale 10% offe-Library read for1 day
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.
This document does not apply to environmental samples.
- Technical specification53 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard72 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation102 pagesSlovenian and English languagesale 10% offe-Library read for1 day
This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also applicable to point-of-care testing (POCT). NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard69 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard62 pagesEnglish languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard64 pagesEnglish, Spanish and Russian languagesale 15% off
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.
This document does not apply to environmental samples.
- Technical specification53 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens. This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics. This document does not apply to environmental samples.
- Technical specification44 pagesEnglish languagesale 15% off
- Technical specification48 pagesFrench languagesale 15% off
- Technical specification48 pagesFrench languagesale 15% off
This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation.
This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA).
This document does not apply to the post-vasectomy assessments.
NOTE Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).
- Standard41 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation.
This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA).
This document does not apply to the post-vasectomy assessments.
NOTE Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).
- Standard41 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the minimum requirements for equipment and critical aspects of the test methods for best practice in laboratories performing basic examination of human semen collected by ejaculation. This document is applicable to the entire process of basic manual semen examination and also to sample preparation for Computer-Aided Sperm Analysis (CASA). This document does not apply to the post-vasectomy assessments. NOTE Given the medico-legal ramifications surrounding the evaluation of post-vasectomy ejaculates, the methodology in this document is in all likelihood inadequate to establish an ejaculate as being completely “clear” (i.e. no spermatozoa in the ejaculate).
- Standard32 pagesEnglish languagesale 15% off
- Standard34 pagesFrench languagesale 15% off
- Standard34 pagesEnglish, Spanish and Russian languagesale 15% off
This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document.
Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated DNA.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification38 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and gives recommendations for the pre-examination phase of human specimens, such as stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.
This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.
Different dedicated measures are taken for pre-examination processes for infectious disease examination (e.g. targeted pathogen identification) and for microbiome DNA examination from tissue (e.g. biopsies). These are outside of the scope of this document.
Different dedicated measures are taken for pre-examination processes for saliva for human genomic DNA examination. These are not described in this document but are covered in CEN/TS 17305, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated DNA.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
- Technical specification38 pagesEnglish languagesale 10% offe-Library read for1 day
This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT). It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.
- Standard39 pagesEnglish languagesale 15% off
- Standard39 pagesEnglish languagesale 15% off
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard91 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks. The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189. This document does not specify acceptable levels of risk. This document does not apply to risks from post-examination clinical decisions made by healthcare providers. This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Standard82 pagesEnglish languagesale 15% off
- Standard87 pagesFrench languagesale 15% off
- Standard86 pagesEnglish, Spanish and Russian languagesale 15% off
This document specifies requirements for safe practices in the medical laboratory (herein after referred to as "the laboratory").
- Standard79 pagesEnglish languagesale 15% off
- Standard84 pagesSpanish languagesale 15% off
- Standard80 pagesSpanish languagesale 15% off
This document gives guidance for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document.
- Technical specification35 pagesEnglish languagesale 15% off
This document defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization that works with, stores, transports, and/or disposes of hazardous biological materials. This document is intended to complement existing International Standards for laboratories. This document is not intended for laboratories that test for the presence of microorganisms and/or toxins in food or feedstuffs. This document is not intended for the management of risks from the use of genetically modified crops in agriculture.
- Standard26 pagesEnglish languagesale 15% off
- Standard27 pagesFrench languagesale 15% off
- Standard27 pagesSpanish languagesale 15% off
- Standard26 pagesSpanish languagesale 15% off
This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also included in this scope. This document also applies to the estimation of MU for results produced by qualitative (nominal) methods which include a measurement step. It is not recommended that estimates of MU be routinely reported with patient test results, but should be available on request. NOTE See Annex B for an example of application of the MU.
- Technical specification73 pagesEnglish languagesale 15% off
- Technical specification77 pagesFrench languagesale 15% off
This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
ISO/TS 17518:2015 provides requirements and guidance for selecting and assessing the quality of reagents to be used for in vitro diagnostic staining in biology. This Technical Specification applies to the professional use of reagents for staining in biology by medical laboratories, and in particular, to those who are responsible for the requisition and evaluation of these reagents in medical laboratory disciplines such as clinical cytology, haematology, histopathology, microbiology, and molecular biology.
- Technical specification15 pagesEnglish languagesale 15% off
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ISO 13130:2011 specifies requirements and tests for desiccators and vacuum desiccators intended for general laboratory purposes such as drying of substances or material.
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 13130:2011 specifies requirements and tests for desiccators and vacuum desiccators intended for general laboratory purposes such as drying of substances or material.
- Standard7 pagesEnglish languagesale 15% off
- Standard7 pagesFrench languagesale 15% off
- Standard12 pagesRussian languagesale 15% off
ISO 24998:2008 specifies requirements and test methods for plain, single-use Petri dishes for microbiological use. ISO 24998:2008 does not apply to products of similar design which may be used for cell or tissue culture purposes. Neither does it apply to dishes supplied ready loaded with microbiological media.
- Standard11 pagesEnglish languagesale 15% off
- Standard11 pagesFrench languagesale 15% off
This European Standard gives guidance for practice for biotechnology operations in research, development and analysis laboratories of containment levels 1, 2, 3 and 4 (see EN 12128 and prEN 12738). This European Standard aims at the protection of workers from biological hazards as well as the environment including plants and animals.
- Standard15 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard, in order to protect the worker and/or the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animal health or the environment. This European Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms.
- Standard15 pagesEnglish languagesale 10% offe-Library read for1 day
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Flow-out and blow-out pipettes are considered. They will only be expected to provide their specified performance during the original operation. The requirements deal with the basis of adjustment, dimensions, delivery time and construction. The determination of accuracy and repeatability and the marking are specified.
- Standard6 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Draft86 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.
The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.
This document does not specify acceptable levels of risk.
This document does not apply to risks from post-examination clinical decisions made by healthcare providers.
This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.
- Draft86 pagesEnglish languagesale 10% offe-Library read for1 day
To develop a list of standardised core terms and definitions to be used by ISO/TC 336 Laboratory Design to enable a consistent and unambiguous understanding of the standard's requirements and its practical application.
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This ISO Technical Specification provides detailed guidance on the implementation of the biorisk management elements outlined in ISO 35001 “Biorisk management for laboratories and other related organisations.” This document leverages the expired CEN Workshop Agreement 16393:2012 Guidance for the Implementation of CWA 15793:2008. (CEN Workshop Agreement 15793:2011 “Laboratory Biorisk Management” – the basis for ISO 35001). This document is intended to complement existing International Standards for laboratories and related facilities including ISO 35001:2019. Implementation guidance to explain what is written in and support action to materialise ISO 35001 is seriously needed, since risk assessment-based biorisk management system is relatively new to laboratories. For ISO 35001 to be implemented globally, this performance-based standard requires supportive documents providing details of how to conform with it. CWA 15793:2012 and CWA 16393:2012 will be used as a informative references for this work.
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- Draft138 pagesEnglish languagesale 15% off
- Draft12 pagesEnglish languagesale 10% offe-Library read for1 day
ISO/TS 20658:2017 specifies requirements and good practice recommendations for the collection, transport, receipt and handling of samples intended for medical laboratory examinations.
ISO/TS 20658:2017 is applicable to medical laboratories and other medical services involved in laboratory pre-examination processes that include the examination request, patient preparation and identification, sample collection, transport, receipt and storage. It may also be applicable to some biobanks.
ISO/TS 20658:2017 does not apply to blood and blood products intended for transfusion.
- Technical specification41 pagesEnglish languagesale 10% offe-Library read for1 day
- Technical specification34 pagesEnglish languagesale 15% off
ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document 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 document can be applicable.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation22 pagesSlovenian and English languagesale 10% offe-Library read for1 day
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
- Standard58 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard – translation93 pagesSlovenian and English languagesale 10% offe-Library read for1 day
ISO 13132:2011 specifies requirements and tests for glass Petri dishes intended for general laboratory purposes and microbiological work.
- Standard11 pagesEnglish languagesale 10% offe-Library read for1 day
ISO/TS 22367:2008 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. ISO/TS 22367:2008 proposes a methodology for finding and characterizing medical laboratory error that would be avoided with the application of ISO 15189.
- Technical specification19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard69 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard62 pagesEnglish languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Standard64 pagesEnglish, Spanish and Russian languagesale 15% off
- Corrigendum1 pageSlovenian languagesale 10% offe-Library read for1 day