2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

EN-ISO 11737-2 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. 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. 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.

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for  the assessment report E&Y Report

20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance

This Standard specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure. This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).

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].

20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019. Awaiting for assessement report from E&Y.
2018-10-17 - TAN : Lack of compliance

20191119 - Negative assessment addressed through BT decision C168/2019 (SV)
2019-03-07-JO-  under HAS assessment at PUB stage. E&Y Report was due on 03 March 2019- Awaiting for  the assessment report E&Y Report

1.1 Inclusions
1.1.1 This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using a mixture of low temperature steam and formaldehyde as sterilizing agent and which operates below ambient pressure.
NOTE Although the scope of this document is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other products and equipment.
1.1.2 This document is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices (see ISO 14937:2009, Table E.1).
1.2 Exclusions
1.2.1 This document does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
NOTE See ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3.
1.2.2 This document does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556‑1.
1.2.3 This document does not specify a quality management system for the control of all stages of production of medical devices.
NOTE It is not a requirement of this document to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appropriate places in the text. Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. Further guidance is given in E.4 of ISO 14937:2009.
1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of LTSF sterilization facilities.
NOTE 1 Safety requirements for sterilizers are specified in IEC 61010‑2‑040.
NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements.
1.2.5 This document does not cover analytical methods for determining levels or residues of formaldehyde and/or its reaction products.
NOTE 1 Attention is drawn to EN 14180.
NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulations specifying limits for the level of formaldehyde residues on medical devices and products.
1.2.6 This document does not cover preparatory measures that might be necessary before sterilization such as cleaning, disinfection and packing.
NOTE For reprocessable medical devices, the manufacturer(s) of these devices can supply information on the preparatory measures (see ISO 17664).

This document provides guidance on auditing management systems, including the principles of auditing,
managing an audit programme and conducting management system audits, as well as guidance on
the evaluation of competence of individuals involved in the audit process. These activities include the
individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of
management systems or manage an audit programme.
The application of this document to other types of audits is possible, provided that special consideration
is given to the specific competence needed.

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
detail specified requirements for designating a medical device as sterile;
specify a quality management system for the control of all stages of production of medical devices;
specify requirements for occupational safety associated with the design and operation of irradiation facilities;
specify requirements for the sterilization of used or reprocessed devices.

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
detail specified requirements for designating a medical device as sterile;
specify a quality management system for the control of all stages of production of medical devices;
specify requirements for occupational safety associated with the design and operation of irradiation facilities;
specify requirements for the sterilization of used or reprocessed devices.

EN ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

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

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.

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 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 population.
The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.
This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to
— ensure the conduct of the clinical performance study will lead to reliable and robust study results,
— define the responsibilities of the sponsor and principal investigator,
— assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and
— protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.
Analytical performance studies are out of the scope of this document.
NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety.
Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document.
NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity.
This document does not include safety information for laboratory workers or other personnel collecting the study specimens.
NOTE 4 Such information is included in other publications[1][12][13].
NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.

20200402JO- link to MDD,IVD, AIMD and M/023,M/252,M/295 removed. These links are included in the previous published version  EN ISO 15223-1:2016 - JT003045

1.1 * Purpose This document defines the development and maintenance life cycle requirements for HEALTH SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for HEALTH SOFTWARE life cycle PROCESSES. 1.2 * Field of application This document applies to the development and maintenance of HEALTH SOFTWARE by a MANUFACTURER. MEDICAL DEVICE SOFTWARE is a subset of HEALTH SOFTWARE (see Figure 2). Therefore, this document applies to: - software as part of a MEDICAL DEVICE; - software as part of specific health hardware; - software as a MEDICAL DEVICE (SaMD); - software-only product for other health use. Figure 2 provides a graphical representation of the health software this document applies to. [Figure 2] NOTE 1 Examples of HEALTH SOFTWARE include the following: 1) software as a part of a MEDICAL DEVICE: software that is an integral part of a device such as an infusion pump or dialysis machine. 2) software as part of specific health hardware: patient wristband printer software, healthcare scanner software, health app on specific wearable hardware (i.e. watch, wristband, chestband). 3) software as a MEDICAL DEVICE (SaMD): software that is itself a MEDICAL DEVICE, such as a software application that performs diagnostic image analysis for making treatment decisions. A definition of software as a MEDICAL DEVICE is provided in [46] 1. 4) software-only product for other health use: hospital information systems, electronic health records, electronic medical records, mobile applications running on devices without physiologic sensors or detectors, software as a service, i.e. software executed in an external environment, providing calculation-results that fulfil the definition of a MEDICAL DEVICE. NOTE 2 This document can be used in the development and maintenance of HEALTH SOFTWARE. Before any type of software can be placed into service, activities are necessary before the software product is integrated into the SYSTEM. These SYSTEM activities are not covered by this document (see Figure 1), but can be found in related product standards (e.g., IEC 60601-1 [1] or IEC 82304-1 [15]). For software as a MEDICAL DEVICE (SaMD) additional guidance on ACTIVITIES at a system level (e.g. clinical EVALUATION) can be found in regulatory authority guidance documents. [...]

2021-07-14 - Lack of compliance - publication on hold.

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 population.
The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.
This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to
— ensure the conduct of the clinical performance study will lead to reliable and robust study results,
— define the responsibilities of the sponsor and principal investigator,
— assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and
— protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.
Analytical performance studies are out of the scope of this document.
NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety.
Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document.
NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity.
This document does not include safety information for laboratory workers or other personnel collecting the study specimens.
NOTE 4 Such information is included in other publications[1][12][13].
NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.

20200402JO- link to MDD,IVD, AIMD and M/023,M/252,M/295 removed. These links are included in the previous published version  EN ISO 15223-1:2016 - JT003045