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volvo 140 lc workshop manualThe pre-existing “Principles” and “Standards” sections have been merged to facilitate its use, as standards are now better identified. The GPGs were prepared through ad hoc co-operation between the EDQM and the European Union Commission. The “Monographs” chapter describes requirements that are to be regarded as harmonised standards for the quality and safety of blood components across Europe. Latest News Latest News Latest News Latest News. Please try again.Please try again.Please try again. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. Full content visible, double tap to read brief content. Videos Help others learn more about this product by uploading a video. Upload video To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. The current custom error settings for this application prevent the details of the application error from being viewed remotely (for security reasons). It could, however, be viewed by browsers running on the local server machine. Blood transfusions are essential when dealing with trauma or major surgery, and are often needed in cancer management, or to treat inherited chronic blood diseases such as Thalassaemia. The manufacture of these products is subject to pharmaceutical legislation, while the donation, collection and testing of plasma is regulated by blood legislation. Most people who are in good health can donate blood. It covers all steps in the transfusion process from donation, collection, testing, processing, and storage to distribution. The European Commission holds regular meetings with them to facilitate communication, to exchange best practices, and to reach a common understanding on the implementation of the Directives.http://dejede.com/userfiles/file/bt-voyager-2500v-user-manual.xml
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Funding in this area is done also through the European Health and Digital Executive Agency (HaDEA). Some recent examples include: The development of training sessions for inspectors in the field of blood and blood components. R (95) 15 8th ed. Title rated 0 out of 5 stars, based on 0 ratings ( 0 ratings ) You have not rated this title. Rate this title Rate this Book, 2002 Current format, Book, 2002, In-library use only. 3 more editions Book, 2002 Current format, Book, 2002, In-library use only. Offered in 0 more formats In this 8th edition, chapter 12 on red cells obtained by aphaeresis has been completely overhauled. Where necessary, chapters have been revised in order to take into account what can be achieved with new technology. Blood — Transfusion — Standards — Europe. Blood banks — Standards — Europe. Details Publication Strasbourg: Council of Europe Pub., c2002. Full details Full details of this title, opens an overlay Opinion From the community What did you think about this title. Add comment Add comment about this title, opens dialog There are no comments from the community on this title More from the community Community lists featuring this title Add to list There are no community lists featuring this title Community contributions Quotations Summaries Videos Suitability Quotations Add quotation There are no quotations from this title. Learn More. PMCID: PMC500943 Guide to the Preparation, Use and Quality Assurance of Blood Components, 4th ed Reviewed by D Stainsby Copyright and License information Disclaimer Copyright notice Full text Full text is available as a scanned copy of the original print version. Get a printable copy (PDF file) of the complete article (133K), or click on a page image below to browse page by page. 792 Associated Data Supplementary Materials Articles from Journal of Clinical Pathology are provided here courtesy of BMJ Publishing Group.http://equipociclistaugeraga.com/ciclistas/userfiles/bt-voyager-220v-manual.xml I have read and accept the Wiley Online Library Terms and Conditions of Use Shareable Link Use the link below to share a full-text version of this article with your friends and colleagues. Learn more. Copy URL. The site uses cookies to offer you a better experience. By continuing to browse the site you accept our Cookie Policy, you can change your settings at any time. View Privacy Policy View Cookie Policy R (95) 15 (Paperback) By continuing to use the site you agree to our use of cookies. Find out more. Registered in England and Wales. Company number 00610095. Registered office address: 203-206 Piccadilly, London, W1J 9HD. Or, add to basket, pay online, collect in as little as 2 hours, subject to availability. If this item isn't available to be reserved nearby, add the item to your basket instead and select 'Deliver to my local shop' (UK shops only) at the checkout, to be able to collect it from there at a later date. Its aim is the attainment of the highest possible levels of health by all people, and clearly the availability of safe blood contributes to this aim. The Global Collaboration in Blood Safety programme started in 1995. It was recognised that with the increased movement of populations and plasma and plasma-derived medicinal products, blood safety could only be improved through global collaboration. Consensus proposals and recommendations are addressed to the participant countries. They are easily and often confused as much of the same terminology is used. In 2012 the CoE had 47 member states with approximately 800 million inhabitants and the EU had 27, with a population of 502 million. All member states of the EU are member states of the CoE. In the field of health the CoE has consistently addressed ethical issues; the most important of these is the non-commercialisation of human substances: blood, tissues and organs. In the 1950s member states started to cooperate in blood transfusion activities.It was conceived to prevent further such wars.http://www.raumboerse-luzern.ch/mieten/bosch-nexxt-premium-washer-service-manual Initially it consisted of six countries. The European Coal and Steel Community (ECSC) was created in 1951: coal and steel had played a major role in the Second World War and cooperation over these assets was seen as a means of preventing further such cataclysms. The European Atomic Energy Community (EAEC or Euratom) came into force in 1958, as did the European Economic Community (EEC) created by the Treaty of Rome in 1957. The Treaty of Maastricht 1992 (the Treaty on the European Union) amended the three existing treaties giving the three Communities (ECSC, EAEC and EEC) increased powers. The EEC was renamed the European Community (EC). These competences are agreed by the treaties and outlined in the acquis communautaire. Competence in the field of blood and blood components was conferred on the EU by the Treaty of Amsterdam 1999 Article 152.This means that the laws governing blood, blood components and tissues extend only to cover the safety of the products and not their clinical use. The texts of the Directives and stages in the consultation process can be found online at www.europarl.eu Pharmacopoeias are collections of standardised specifications that define the quality of pharmaceutical preparations, their constituents and even their containers. The European Pharmacopoeia (Ph Eur) monographs are binding on the EU and the participating member states. Its main responsibility is the protection and promotion of public health through the evaluation and supervision of medicines for human and veterinary use. The EMEA coordinates the evaluation and supervision of medicinal products throughout the EU. Industrially prepared, fractionated plasma products are medicinal products and the Ph Eur monographs are mandatory. EU legislation must be transposed into member states’ own legislation within a defined time frame.http://czcomunicacion.com/images/bristol-babcock-rtu-3330-manual.pdf R (95) 15 (Health) R (95) 15 (Health) This guide will be of interest to blood transfusion centres, legislators, health personnel and to all those working in the field of blood transfusion services. If it is added to AbeBooks by one of our member booksellers, we will notify you! All Rights Reserved. Plasma derivatives are prescription medicines subject to full regulation under provisions requiring standards, licensing of manufacture and inclusion in the Australian Register of Therapeutic Goods (ARTG) after review of manufacturing, pre-clinical and clinical data. Under the Act 'blood' means whole blood extracted from human donors and 'blood components' means therapeutic components that have been manufactured from blood (including red cells, white cells, progenitor cells, platelets and plasma). 'Blood components' does not include products derived through fractionation of plasma. Where storage occurs and supervision of that storage by the same medical practitioner cannot be guaranteed, the blood or blood components may not be exempt. To obtain a licence for the manufacture, blood and blood components and plasma must be manufactured in compliance with the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013 and in a manner consistent with the relevant Technical Master file lodged by the manufacturer. The detailed technical and scientific information must satisfy the TGA that: the blood or blood components are manufactured according to the standards described in Therapeutic Goods Order No. 88 - Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products, Therapeutic Goods Order No.https://www.belladermeestetica.com.br/wp-content/plugins/formcraft/file-upload/server/content/files/1628903f61f5d9---canon-6216-manual.pdf 81 - Standards for Blood and Blood Components; and that haematopoietic progenitor cells derived from cord blood are manufactured according to the standards described in Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood). If you would like to redeem your KAB credit, please log in. Its main objective is defending the human rights of European citizens. In promoting the principle of the non-commercialisation of substances of human origin, the Council of Europe has developed a substantial programme in the field of blood transfusion. Its main contribution is the annual revision of the Guide to the Preparation, Use and Quality Assurance of Blood Components. The article also sets out other activities and indicates the imminent changes of the legislative environment in Europe with regard to blood transfusion. You will be sent an e-mail containing a link to reset your password.Follow the instructions and try to log in again. By continuing to browseFind out about Lean Library here Find out more and recommend Lean Library. Download PDFThis product could help you Lean Library can solve it Content ListAcknowledgementsSimply select your manager software from the list below and click on download.Simply select your manager software from the list below and click on download.For more information view the SAGE Journals Sharing page. Search Google ScholarSearch Google ScholarWe demonstrate how shifts in the moral economy of blood donation that followed from the outbreak of the human immunodeficiency virus (HIV) epidemic led to the prioritisation of donor deferral policies in efforts to enhance blood safety across Europe. Qualitative analyses of the Guide’s 19 editions reveal 3 dimensions through which these figures have become increasingly stabilised over time: in terms of their ontology, temporality and risk-related exceptionality.www.cnlpzz.com/d/files/color-imagerunner-c3200-manual.pdf Previously deferred indefinitely, these groups of persons are now able to donate blood if the listed behaviours did not occur within the previous 12 months. This incorporation into groupings vulnerable to HIV, and also deferred from donation, underscores how being recognised as worthy of protection can also involve new forms of social exclusion. As a realm through which recent social and political shifts have thus brought new forms of both inclusion and exclusion, blood donation deferral policies can be seen as contested grounds for the enactment of recognition, rights and belonging. Building on this observation, we ask in this article about how the emergence of and European responses to the HIV epidemic came to transform both the moral economy of blood donation, and the terms of inclusion and exclusion of donor deferral policies on a European level. As such, they become perceived vectors of illness by way of alleged risk rather than biological phenomena. In the context of blood donor restrictions, behaviours of the past, it might be said, come to define the body of an individual even more than the biological impact of those behaviours. Whereas the identity-based language and temporal qualities of deferral policies have thus changed in recent years for certain groups in Germany, the permanent exclusion of persons who use drugs and the time-dependent deferral based on travel, imprisonment and partner behaviours continue in the current guidelines. The landscape of donation deferral has shifted in other European countries as well. Department of Health and Social Care, 2017 ). This followed 2011 changes in England, Scotland and Wales, and in Northern Ireland in 2016, which reduced the lifelong deferral procedure for men who have sex with men to 12 months ( Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), 2017: 4).https://www.investing-in-women.com/wp-content/plugins/formcraft/file-upload/server/content/files/162890407d1ccd---Canon-6530-service-manual.pdf The committee also considered relaxing restrictions for people who inject drugs, but concluded that such an adjustment would necessitate changes to European-level legislation ( SaBTO, 2017: 100). Following from this interest in the cultural figures that take shape and are enacted through policy documents ( Bennett, 2009; Chan, 2015; Epstein, 2007 ), we rely here on blood donor restriction recommendations and not on personal accounts from donation administrators, potential and actual donors, or blood donor activists. Additional literature and European-level blood policies that have emerged around related debates will further contextualise and elaborate them, as will brief discussion of the closely related figures of the ideal donor and potential donation recipient, which are co-produced in relation to them. In what follows, we first trace the emergence of what we have called a European blood donation regime, and the increasingly central role of the Council of Europe in shaping blood donor deferral policies on the European level. We then look at how the moral economy of donation has changed with the emergence of the HIV epidemic, noting in particular that it became entwined with notions of European belonging, responsibility and citizenship. Based on a critical qualitative analysis of all published Guides (from 1992 to 2017) by the Council of Europe, we then map shifts in the emergent European figures of risk by presenting three dimensions through which they have become increasingly essentialised and stabilised over time: in terms of their ontology, temporality and risk-related exceptionality. The Europeanisation of blood donation In 1953, shortly after the creation of the Council, mass injury from floods in the Netherlands provoked new awareness about the nation’s limited supply of blood.http://akbmodel.com/wp-content/plugins/formcraft/file-upload/server/content/files/16289040fa976b---canon-6570-manual.pdf Failed attempts by neighbouring countries to offer support through blood donation exposed a need for enabling the safe use of blood in one European country when it was collected according to the cultural logics of another. If the newly constituted Council was created in part to reduce intra-national barriers, these deficient transnational donation structures threatened its aims and purpose. Not just a means to enact European solidarity, Genetet understood blood donation to help clarify the Council’s identity. Blood donation offered a possibility to carve out space as a health authority within a landscape of international actors that already included the World Health Organization (WHO), the League of Red Cross and Red Crescent Societies, and the International Society of Blood Transfusion, each with their own institutional character and function. Without techniques to determine the presence of blood-borne infections, early assessments relied on visible symptoms and self-reporting of medical histories. The Council also strongly advised that blood donation be voluntary. Provoked by a growing world of policies on transfusion, that gift also became a way to enact one’s sense of belonging to a national or even European community. However, as the next section shows, the (mis-)management of HIV provoked a radical transformation in the moral economy that governs the logics of donor selection and thus also the contours of European citizenship. Based on the brief genealogy presented earlier, and in the absence of an effective HIV test, this call to self-deferral was consistent with earlier strategies for managing risks of transmission through transfusion. Initially developed by the American Red Cross, the notice identified groups thought to threaten the safety of donation recipients, and who were thus asked to refrain from donating.www.cndasion.com/d/files/color-imagerunner-c3080i-manual.pdf From the logic of this norm-setting institution, it might be said that this first European-level policy followed from a heightened sense of responsibility for securing public health in the context of an emerging threat rather than from an obligation to safeguard social equality. Given governmental missteps, and with no stigmatised behaviours to blame for infections, trust in the state was reduced ( Farrell, 2012; Rabinow, 1999: 80). As such, it justifies exclusionary measures considered discriminatory in the name of the greater good of society, and enables the continuity of exclusions until their inclusion has been established as harmless. Moreover, even once testing became available, donation authorities were slow to update operationalisation of the principle and adjust deferral policies accordingly. Mapping figures of risk Starting with the aforementioned first European-level policy engagement with AIDS, the Council has adopted numerous blood-related policies, which established increasingly stringent standards for donation authorities, the testing of donors (once HIV-antibody tests were made available in 1985) and donor selection criteria. One of the most influential milestones was the Guide on the preparation, use and quality assurance of blood components. Although its name has remained remarkably stable, the Guide has significantly increased in size (from 129 to 545 pages), its scope has expanded, and its technical precision has been enhanced. Of interest here are both the figures themselves, and also the terms through which these figures have shifted. To identify the patterns of these figures and shifts, we took up a reflexive thematic analysis ( Braun and Clarke, 2006; Charmaz, 2006 ) of all Guides and the published documentation of Guide development and refinement, which involved the extraction and interpretation of themes through the coding (with MAXQDA) of all materials. Risk ontologies First, the succession of Guides demonstrates the enhanced precision with which persons and behaviours were grasped and assessed for deferral. The language of several early Council policies exemplified the categorical terminology used to describe persons thought to be at an elevated risk of HIV, and therefore also thought to pose a risk to the general population. The Council’s aforementioned 1983 Recommendation, for example, simply replicated US figures of risk. Given the ongoing shifts in knowledge about the epidemic in Europe at the time, the authors of the earliest Guides did not delineate particular figures of risk, but rather adopted a generalised language of risk and safety. While effective antiretroviral therapy became available and the quality and accessibility of epidemiological data in Europe increased significantly in the mid-1990s ( Steffen, 2012 ), subsequent Guides were only slightly modified. While this statement might suggest that figures of risk should vary in conjunction with local epidemiological data, an enhanced variety of figures became decipherable for the first time in the same Guide as the sample questionnaire was rendered more categorical. There was thus a presumption of varying epidemics across the region, each with its own conceivable categories of risk, just as there was an expansion in the number of figures meant to guide all Member States. Have you ever accepted payment for sex, in money or drugs. For men: Have you ever had sex with another man. For women: To the best of your knowledge has any man with whom you have had sex during the past 12 months had sex with another man. During the past 12 months: Have you had sexual contact with: a partner who is HIV positive or has hepatitis.A final shift took place in 2015 when the sample questionnaire was significantly expanded. The expansion and fortification of figures of risk that resulted from the increased precision of Guide questionnaires also involved a shift in the type of citizen that it relied upon and further shaped. As the questionnaire became increasingly confessional, potential donors were no longer expected to assess risk themselves and then refrain from donation on their own; instead they were guided through the world of risk by the administrators of the questionnaire, and were denied or awarded the right to donate by an external authority. We are thus talking about an increasingly passive (compliant) rather than active (responsible) citizen. Figuration through temporality Second, the succession of Guides manifests a shift in the temporal dimension of deferral. Indeed, in light of the changes discussed at the opening of this article, it is remarkable that the first Guides encouraged permanent deferral only for persons who used drugs. Although the first Guide pre-dated the WHO publication, its deferral time frame continued to deviate from WHO norms for over a decade. The decision to defer only based on 12 months was, in retrospect, particularly significant given that the publication of this initial Guide took place in the aftermath of scandalised reports about HIV infections through donation, as the spread of the epidemic increased across Europe, and also before antiretroviral therapy began to prove effective. From this perspective, the 2006 shift in the temporality of deferral contributed to the harmonisation of the logics guiding blood donation policies, which translated into the further fortification of the European blood donation regime. Here again, this move towards aligning precautionary logics came into tension with the conviction that local conditions and available technologies should inform local deferral practices. Figuration through (de-)exceptionalisation As presented earlier, the initial Guide followed from an economy of distrust that emerged around scandalised events of HIV infection. Hence, the Guide came into existence in relation to the exceptional status of HIV and the perceived risks with which it was associated. Yet, it also documents what is either the progressive de-exceptionalisation of the virus, or the repositioning of other infections to the exceptional status of HIV. For example, the first Guide advised providing prospective donors with accurate information on AIDS, and only this information was referenced in the sample questionnaire. In gradually grouping these three conditions together, one sees that the authors began to think about HIV together with hepatitis B and C, and indeed that they came to equate the recommended questions to ask in relation to each virus, and thus, also their routes of transmission and perceived figures of risk. With these changes, we see a gradual de-exceptionalisation of HIV ( Smith and Whiteside, 2010 ) as the primary condition structuring deferral. This observation makes particularly apparent that hepatitis B and C became exceptionalised on the European level only after HIV came to provoke the creation of figures of risk as an advised tool for managing the possible transmission of infections through donation. This group also has a higher risk of syphilis, gonorrhoea, as well as infection by hepatitis B and hepatitis A viruses’ ( EDQM, 2017: 458). Which condition functions, from a biomedical perspective, to justify the deferral based on existing testing technologies and the effectiveness of available treatments is of less interest. Instead, what becomes apparent is that these conditions come to be entangled in their association with particular figures of risk, and that they each contribute to the production or re-fortification of these figures as and through risk. But how do levels of acceptable risk change based on the futurity of an illness (e.g. curability)? And how do earlier moral economies influence our understanding of the conditions that have become associated with HIV in donor screening guidelines. Whatever our answers, it is clear that in the context of European blood donation regulation, HIV-related figures of risk came, over time, to apply to each of the viruses indiscriminately. This process of developing a particularly robust health-governing structure in response to HIV, and then expanding that structure to other, also previously existing illnesses, can be observed in other contexts of health management in Europe as well ( Steffen, 2012 ). Figures of risk in the making Pressure from various groups excluded from donation, especially gay-rights activists, helped to influence the aforementioned national changes in deferral criteria. A 2012 Memorandum provides insight into how a variety of resources and rationalities, at times with conflicting assumptions and implications, come to produce the shifting figures of risk as presented in previous sections. Particularly influential was the relative abundance of available data on HIV, which justified the group’s all but singular focus on that virus. The recognition of and insistence on the internal diversity of prospective heterosexual blood donors likely follows from the conviction that one could not defer from donation such a significant portion of society. Among men who have sex with men, alternatively, about whom exists the largest amount of data, justification for preserving the permanent deferral was based on their existence as a group or network of risk, rather than on behaviours of risk. While it is beyond the scope of this article to analyse the biostatistics behind these calculations of risk, the logics analysed here underscore that the boundary work involved in producing particular concepts of risk can be subjective, imperfect and variable. In other words, there are ways of assessing people with deferral guidelines that do not rely on the production of collectivising figures. This may be of particular interest when one considers the Guides of the Council, in which the logics of figuration have become firmly anchored, with their ontology made increasingly precise and explicit, with the gradual elimination of the time-dependent assessment of behaviours, and an increase in the number of health conditions mobilised to justify their existence. In its (re-)creation of an altruistic European subject, it has been suggested that the act of donation constitutes a particular type of European citizenship. While the protection of recipients of blood components has increasingly become a responsibility of European policymakers, an enhanced responsibility for securing blood safety has been placed on donation administrators rather than prospective donors. This is reflected in a shift away from self-deferral towards increasingly stringent screening procedures, and the confessionalisation of pre-donation assessments. At the same time, advised screening processes depend on the responsibility of the donor to be self-aware, risk-aware and truthful about their medical histories and practices that locate them within a particular group pre-identified as risky. Hence, rather than grasp potential donors through individualised practices of risk, they become grasped through categories to which they are assigned, and thus, become conflated with what we have called figures of risk: men who have sex with men, people who use drugs, sex workers. What does it mean for concepts of European citizenship that the advised deferral practices of the Council are based on collectivising and generalising figures where they could be based on individual practices.