This document gives recommendations for the handling, documentation, storage and processing of frozen tissue specimens intended for the examination of isolated DNA during the pre-examination phase before a molecular examination is performed.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vit...
view more

    • sale 10% off
    • Standard
      23 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Draft
      20 pages
      English language
    • e-Library read for
      1 day

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis model.

    • sale 10% off
    • Standard
      76 pages
      English language
    • e-Library read for
      1 day

This document specifies requirements and recommendations for the pre-examination phase of human specimens, including saliva, skin, urine and stool, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, storage, processing 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 diagnos...
view more

    • sale 10% off
    • Technical specification
      38 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Technical specification
      37 pages
      English language
    • e-Library read for
      1 day

This document specifies requirements and gives recommendations for the handling, documentation and processing of urine, venous blood plasma and serum intended for metabolomics analysis in the pre-examination processes. This document is applicable to metabolomics examinations and can be used by biomedical laboratories, customers of laboratories, in vitro diagnostics developers and manufacturers, institutions and companies performing biomedical research, biobanks, and regulatory authorities.

    • sale 15% off
    • Standard
      18 pages
      English language
    • sale 15% off
    • Standard
      18 pages
      French language
    • sale 15% off
    • Draft
      17 pages
      English language
    • sale 15% off
    • Draft
      17 pages
      French language

This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intend...view more

    • sale 15% off
    • Standard
      15 pages
      English language
    • sale 15% off
    • Standard
      17 pages
      French language
    • sale 15% off
    • Draft
      15 pages
      English language
    • sale 15% off
    • Draft
      17 pages
      French language

This document applies to medical devices other than in vitro diagnostic medical devices manufactured
utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It
specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations
associated with such devices, to estimate and evaluate the resulting risks, to control these risks,
and to monitor the effectiveness of that control. Furthermore, it outlines the decision process ...
view more

    • sale 10% off
    • Standard
      37 pages
      English language
    • e-Library read for
      1 day

This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk
management process;
— the general categorization of medical devices based on the nature and duration of their contact with
the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of t...
view more

    • sale 10% off
    • Standard
      50 pages
      English language
    • e-Library read for
      1 day

This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following: — test sample selection; — selection of representative portions from a medical device; — test sample preparation; — experimental controls; — selection of, and require...view more

    • sale 15% off
    • Standard
      21 pages
      English language
    • sale 15% off
    • Standard
      22 pages
      French language
    • sale 15% off
    • Draft
      26 pages
      English language
    • sale 15% off
    • Draft
      28 pages
      French language

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2. This document includes: — pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure; — details of in vitro and in vivo irritation tes...view more

    • sale 15% off
    • Standard
      60 pages
      English language
    • sale 15% off
    • Standard
      62 pages
      French language
    • sale 15% off
    • Standard
      62 pages
      French language
    • sale 15% off
    • Draft
      65 pages
      English language
    • sale 15% off
    • Draft
      65 pages
      French language

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 includ...view more

    • sale 15% off
    • Standard
      39 pages
      English language
    • sale 15% off
    • Standard
      39 pages
      English language
    • sale 15% off
    • Draft
      39 pages
      English language

This document specifies a framework for the identification, and if necessary, quantification of
constituents of a medical device, allowing the identification of biological hazards and the estimation
and control of biological risks from material constituents, using a generally stepwise approach to the
chemical characterization which can include one or more of the following:
— the identification of its materials of construction (medical device configuration);
— the characterization of the mat...
view more

    • sale 10% off
    • Standard
      81 pages
      English language
    • e-Library read for
      1 day

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for ...view more

    • sale 15% off
    • Standard
      26 pages
      English language
    • sale 15% off
    • Standard
      28 pages
      French language
    • sale 15% off
    • Draft
      29 pages
      English language

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1. NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising a...view more

    • sale 15% off
    • Standard
      15 pages
      English language
    • sale 15% off
    • Standard
      17 pages
      French language
    • sale 15% off
    • Draft
      18 pages
      English language

This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid ...view more

    • sale 15% off
    • Standard
      22 pages
      English language
    • sale 15% off
    • Draft
      22 pages
      English language

This document describes one reference method, broth micro-dilution, for determination of MICs.
The MIC can be a guide for the clinician, and reflects the activity of the drug under the described
test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics,
or bacterial resistance mechanisms. This allows categorisation of bacteria as “susceptible” (S),
“intermediate” (I), or “resistant” (R). In addition, MIC distributions can be used to define wild type
...
view more

    • sale 10% off
    • Standard
      27 pages
      English language
    • e-Library read for
      1 day

This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). This document specifies general requirements intended to — protec...view more

    • sale 15% off
    • Standard
      83 pages
      English language
    • sale 15% off
    • Standard
      83 pages
      English language
    • sale 15% off
    • Standard
      90 pages
      French language
    • sale 15% off
    • Standard
      90 pages
      French language
    • sale 15% off
    • Standard
      90 pages
      French language
    • sale 15% off
    • Draft
      91 pages
      English language

This document specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand. This document can be applied in cases when certified...view more

    • sale 15% off
    • Standard
      20 pages
      English language
    • sale 15% off
    • Standard
      21 pages
      French language

This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs). ...view more

    • sale 15% off
    • Standard
      54 pages
      English language
    • sale 15% off
    • Standard
      57 pages
      French language

EN-ISO 22367 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, accura...view more

    • sale 10% off
    • Standard
      91 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Standard
      91 pages
      English language
    • e-Library read for
      1 day

This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. physico‑chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness. This docu...view more

    • sale 15% off
    • Technical specification
      13 pages
      English language

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, acc...
view more

    • sale 10% off
    • Standard
      91 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Standard
      91 pages
      English language
    • e-Library read for
      1 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, accu...view more

    • sale 15% off
    • Standard
      82 pages
      English language
    • sale 15% off
    • Standard
      87 pages
      French language

This document specifies requirements for safe practices in the medical laboratory (herein after referred to as "the laboratory").

    • sale 15% off
    • Standard
      79 pages
      English language

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cell) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) of CTCs during the pre-examination Phase before the cytopathological evaluation is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed ...
view more

    • sale 10% off
    • Technical specification
      19 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Technical specification
      19 pages
      English language
    • e-Library read for
      1 day

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human cellular RNA isolated from Circulating Tumor Cells (CTCs) during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vi...
view more

    • sale 10% off
    • Technical specification
      24 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Technical specification
      24 pages
      English language
    • e-Library read for
      1 day

This document gives guidelines on the handling, storage, processing and documentation of venous blood
specimens intended for the examination of human genomic DNA isolated from Circulating Tumor Cells (CTCs) during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro di...
view more

    • sale 10% off
    • Technical specification
      27 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Technical specification
      28 pages
      English language
    • e-Library read for
      1 day

This document gives guidelines on the handling, storage, processing and documentation of venous blood
specimens intended for the examination of human genomic DNA isolated from Circulating Tumor Cells (CTCs) during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro di...
view more

    • sale 10% off
    • Technical specification
      27 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Technical specification
      28 pages
      English language
    • e-Library read for
      1 day

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood and the CTC (Circulating Tumor Cell) enrichment, CTC isolation and other preparations for analytical staining (i.e., conventional cytochemical and immunocytochemical staining) of CTCs during the pre-examination Phase before the cytopathological evaluation is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed ...
view more

    • sale 10% off
    • Technical specification
      19 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Technical specification
      19 pages
      English language
    • e-Library read for
      1 day

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human cellular RNA isolated from Circulating Tumor Cells (CTCs) during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vi...
view more

    • sale 10% off
    • Technical specification
      24 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Technical specification
      24 pages
      English language
    • e-Library read for
      1 day

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following: — the identification of its materials of construction (medical device configuration); — the characterization of the material...view more

    • sale 15% off
    • Standard
      66 pages
      English language
    • sale 15% off
    • Standard
      72 pages
      French language

This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical labo...view more

    • sale 10% off
    • Standard
      25 pages
      English language
    • e-Library read for
      1 day
    • sale 15% off
    • Standard
      5 pages
      English language
    • sale 15% off
    • Standard
      5 pages
      French language
    • sale 15% off
    • Standard
      15 pages
      English language
    • sale 15% off
    • Standard
      16 pages
      French language

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. This document is not applicable to: a) the evaluat...view more

    • sale 15% off
    • Standard
      11 pages
      English language
    • sale 15% off
    • Standard
      10 pages
      French language

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.

    • sale 15% off
    • Technical specification
      35 pages
      English language

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 feed...view more

    • sale 15% off
    • Standard
      26 pages
      English language

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used...
view more

    • sale 10% off
    • Standard
      25 pages
      English language
    • e-Library read for
      1 day

This document provides recommendations and requirements on the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before an analytical test is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used ...view more

    • sale 15% off
    • Standard
      17 pages
      English language
    • sale 15% off
    • Standard
      19 pages
      French language

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 M...view more

    • sale 15% off
    • Technical specification
      73 pages
      English language
    • sale 15% off
    • Technical specification
      77 pages
      French language

This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or no...view more

    • sale 15% off
    • Standard
      19 pages
      English language
    • sale 15% off
    • Standard
      19 pages
      French language

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended pop...view more

    • sale 15% off
    • Standard
      56 pages
      English language
    • sale 15% off
    • Standard
      61 pages
      French language

This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also i...view more

    • sale 10% off
    • Standard
      28 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Standard
      28 pages
      English language
    • e-Library read for
      1 day

This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for genomic DNA analysis examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by (e.g., medical laboratorie...view more

    • sale 10% off
    • Standard
      28 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Standard
      28 pages
      English language
    • e-Library read for
      1 day

This document gives requirements on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and...
view more

    • sale 10% off
    • Technical specification
      17 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Technical specification
      17 pages
      English language
    • e-Library read for
      1 day

This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory cu...view more

    • sale 10% off
    • Standard
      25 pages
      English language
    • e-Library read for
      1 day

This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory cu...view more

    • sale 10% off
    • Standard
      30 pages
      English language
    • e-Library read for
      1 day

This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be ...view more

    • sale 10% off
    • Standard
      27 pages
      English language
    • e-Library read for
      1 day

This document gives requirements on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and...
view more

    • sale 10% off
    • Technical specification
      17 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Technical specification
      17 pages
      English language
    • e-Library read for
      1 day

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnos...
view more

    • sale 10% off
    • Standard
      28 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Standard
      28 pages
      English language
    • e-Library read for
      1 day

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes.
This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnost...
view more

    • sale 10% off
    • Standard
      28 pages
      English language
    • e-Library read for
      1 day
    • sale 10% off
    • Standard
      28 pages
      English language
    • e-Library read for
      1 day