M/252 - In vitro diagnostic med. dev.

DOW = DAV+36 months

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 non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond
the scope of this document, modifications of the basic method are required for certain antimicrobial
agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a
separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g.
disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure
comparable and reliable results.

This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place.
NOTE Guidance on the application of this document can be found in ISO/TR 24971[9].

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

This document specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. This document also applies to receptacles containing media for blood culture.
This document does not specify requirements for capillary blood specimen receptacles or arterial blood specimen receptacles. This document does not specify requirements and test methods for single-use receptacles intended for the collection of specimens, other than blood.

ISO 6710:2017 specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers.
It does not specify requirements for blood collection needles, needle holders, blood culture receptacles or "arterial" blood gas collection devices that can be used for venous blood.

This document identifies requirements for symbols used in medical device labelling that convey
information on the safe and effective use of medical devices. It also lists symbols that satisfy the
requirements of this document.
This document is applicable to symbols used in a broad spectrum of medical devices, which are
marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated
documentation. The requirements of this document are not intended to apply to symbols specified in
other standards.

ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.
ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.

This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
NOTE    For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in EN ISO 13408-7 (in preparation).

This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
NOTE   For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.

ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.
ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:
the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;
the establishment of stability of the IVD reagent in use after the first opening of the primary container;
the monitoring of stability of IVD reagents already placed on the market;
the verification of stability specifications after modifications of the IVD reagent that might affect stability.

This International Standard specifies requirements for in vitro glucose monitoring systems that measure
glucose concentrations in capillary blood samples, for specific design verification procedures and for
the validation of performance by the intended users. These systems are intended for self-measurement
by lay persons for management of diabetes mellitus.
This International Standard is applicable to manufacturers of such systems and those other organizations
(e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing
the performance of these systems.
This International Standard does not:
— provide a comprehensive evaluation of all possible factors that could affect the performance of
these systems,
— pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,
— address the medical aspects of diabetes mellitus management,
— apply to measurement procedures with measured values on an ordinal scale (e.g. visual,
semiquantitative measurement procedures), or to continuous glucose monitoring systems,
— apply to glucose meters intended for use in medical applications other than self-testing for the
management of diabetes mellitus

ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.
ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.

ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.
ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:
the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;
the establishment of stability of the IVD reagent in use after the first opening of the primary container;
the monitoring of stability of IVD reagents already placed on the market;
the verification of stability specifications after modifications of the IVD reagent that might affect stability.

ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.

This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Although this International Standard primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.
Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4:2009 can also be applied to accessories, where appropriate.
ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.
ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
ISO 18113-3:2009 can also be applied to accessories, where appropriate.

This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements
for information supplied by the manufacturer of IVD medical devices.
This part of ISO 18113 does not address language requirements, since that is the domain of national laws and
regulations.
This part of ISO 18113 does not apply to
a) IVD devices for performance evaluation (e.g., for investigational use only),
b) instrument marking,
c) material safety data sheets.

ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.

ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.
ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
ISO 18113-3:2009 can also be applied to accessories, where appropriate.

ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.

ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing.
ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing.
ISO 18113-4:2009 can also be applied to accessories, where appropriate.
ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.

ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.

This International Standard specifies requirements for certified reference materials and the content of their supporting documentation for them to be considered as higher order according to ISO 17511. It is applicable to reference materials classifiable as primary measurement standards,   secondary measurement standards, [RD] and international conventional calibrators  that function either as calibrators or trueness control materials. [RD What about precision control materials, cf. 4.5]This International Standard also provides requirements on how data shall be collected for value determination and how to present the assigned value and its measurement uncertainty. This International Standard applies to reference materials with assigned values of differential or rational quantities. For nominal properties and ordinal quantities, see Annex A. This International Standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although many elements may be helpful.

This International Standard specifies requirements for the content and format of a reference measurement procedure.This International Standard applies to reference measurement procedures providing values of differential or rational quantities. For nominal properties and ordinal quantities.This International Standard is valid for any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference measurement procedure.

ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.
ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.

1.1 This document specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
1.2 This document is not applicable to:
a) sterility testing for routine release of product that has been subjected to a sterilization process,
b) performing a test for sterility (see 3.12),
NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 11137-2, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.
c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and
d) culturing of biological indicators or inoculated products.
NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7.

2021-04-26_JO: BT N 12459 and BT168/DG12120/DV to decouple from  Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulations 2017/745

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 non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

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).
All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.
NOTE 1 Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.
This document is applicable to:
a) all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales.
b) IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.
c) RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).
d) IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.
e) IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).
This document is not applicable to:
a) calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand;
b) control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;
c) control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;
d) properties reported as nominal scales and ordinal scales, where no magnitude is involved.
NOTE 2 Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.
NOTE 3 Ordinal s

This standard specifies requirements and test methods for single-use evacuated and non evacuated receptacles, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination.
NOTE 1   Requirements and test methods for evacuated and non evacuated single use venous blood specimen containers are specified in prEN 14820.
NOTE 2   While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened, this standard does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test.
This standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.

This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:
- scheme design and organisation;
- identification of procedures (IVD MDs) used by the participant;
- classification and evaluation of data.
NOTE   External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs.
This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

This standard specifies requirements and test methods for single-use evacuated and non evacuated receptacles, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination.
NOTE 1   Requirements and test methods for evacuated and non evacuated single use venous blood specimen containers are specified in prEN 14820.
NOTE 2   While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened, this standard does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test.
This standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.

This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:
- scheme design and organisation;
- identification of procedures (IVD MDs) used by the participant;
- classification and evaluation of data.
NOTE   External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs.
This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.

This EN specifies how to assure the traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes, and provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. This EN describes requirements for the selection and properties of enzyme calibration materials appropriate to their use as elements of a calibration hierarchy of measurement procedures and calibrators.

This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EU verification by a notified body.
Two different provisions are addressed:
a) verification by testing attributes and/or variables on a statistical basis;
b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control.
This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.

ISO 18153:2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes.
The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.
The following subjects are outside the scope of ISO 18153:2003: requirements for the design or selection of a reference measurement procedure; quantities involving mass of enzyme or immunoreactivity of enzymes; control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; properties involving nominal and ordinal scales.

This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EU verification by a notified body.
Two different provisions are addressed:
a) verification by testing attributes and/or variables on a statistical basis;
b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control.
This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.

This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer.
This standard does not address medical aspects of IVD MDs for self-testing.

This standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection.
The standard does not apply to the following:
   - instruments and specimen receptacles;
   NOTE 1   The prevention of infection due to handling of biological materials throughout such  equipment is addressed in other relevant International and/or European Standards.
   - general aspects of workers' protection;
   - transportation of infectious goods;
   - disposal measures.
   NOTE 2   Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.

This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.
NOTE   For a selection of publications on specific evaluation plans see Bibliography.
Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs.
In particular, this standard applies to IVD MDs to
- show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer,
- establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to
- satisfy the requirements of a quality system for design validation.

This standard specifies requirements related to design and manufacture in order to effectively control the risk of infection caused by in vitro diagnostic reagents including reagent products, calibrators, control materials and kits, hereinafter called IVD reagents. The standard is applicable to in vitro diagnostic reagents containing material of human origin. The standard is also applicable to in vitro diagnostic reagents containing materials obtained by biotechnology processes or materials of animal origin, in particular in view of relevant zoonoses, when the results of a risk analysis reveal that there is a risk of human infection.
The standard does not apply to the following:
   - instruments and specimen receptacles;
   NOTE 1   The prevention of infection due to handling of biological materials throughout such  equipment is addressed in other relevant International and/or European Standards.
   - general aspects of workers' protection;
   - transportation of infectious goods;
   - disposal measures.
   NOTE 2   Some of the most relevant documents relating to aspects not covered by this standard are listed in Bibliography for information.

Migrated from Progress Sheet (TC Comment) (2000-07-10): UAP of 4 months (TC Res 5/1999) (CC/990525)

This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer.
This standard does not address medical aspects of IVD MDs for self-testing.