11.100.20 - Biological evaluation of medical devices
ICS 11.100.20 Details
Biological evaluation of medical devices
Évaluation biologique des dispositifs médicaux
Biološko ovrednotenje medicinskih pripomočkov
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This document specifies the process and requirements for the toxicological risk assessment of medical
device constituents. The methods and criteria used to assess whether exposure to a constituent
is without appreciable harm are also specified. The toxicological risk assessment can be part of the
biological evaluation of the final product, as described in ISO 10993-1.
The process described in this document applies to chemical characterization information obtained in
line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or
analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether
the toxicological risks related to the constituents are negligible or tolerable.
The process described in this document is not intended to apply to circumstances where the
toxicological risk has been estimated by other means, such as:
— constituents, excluding cohort of concern or excluded chemicals, that are present in or extracted from
a medical device at an amount representative of patient exposure below a relevant, toxicologicallybased
reporting threshold (see applicable requirements in ISO 10993-18:2020, Annex E and
ISO/TS 21726);
— a new or changed medical device for which chemical or biological equivalence has been established
with an existing biocompatible or clinically established medical device (see applicable requirements
in ISO 10993-18:2020, Annex C).
The process described in this document is also not applicable to:
— medical device constituents that do not contact the body (e.g. in vitro diagnostics);
— biological risks associated with physical interactions of the medical device with the body (i.e.
application of mechanical forces, energy or surface morphology, etc.), provided that the chemical
exposure is not changed;
— active pharmaceutical ingredients of device-drug combination products or biologic components of
device-biologic combination products as additional regulatory considerations can apply;
— exposure to a particular constituent that arises from sources other than the device, such as food,
water or air.
- Standard78 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1.
The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable.
The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as:
— constituents, excluding cohort of concern or excluded chemicals, that are present in or extracted from a medical device at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see applicable requirements in ISO 10993-18:2020, Annex E and ISO/TS 21726);
— a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see applicable requirements in ISO 10993-18:2020, Annex C).
The process described in this document is also not applicable to:
— medical device constituents that do not contact the body (e.g. in vitro diagnostics);
— biological risks associated with physical interactions of the medical device with the body (i.e. application of mechanical forces, energy or surface morphology, etc.), provided that the chemical exposure is not changed;
— active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations can apply;
— exposure to a particular constituent that arises from sources other than the device, such as food, water or air.
- Standard78 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment13 pagesEnglish languagesale 10% offe-Library read for1 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 materials of construction via the identification and quantification of
their chemical constituents (material composition);
— the characterization of the medical device for chemical substances that were introduced during
manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
— the estimation (using laboratory extraction conditions) of the potential of the medical device,
or its materials of construction, to release chemical substances under clinical use conditions
(extractables);
— the measurement of chemical substances released from a medical device under its clinical conditions
of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or
quantification) of degradation products. Information on other aspects of degradation assessment are
covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body
contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support
a biological evaluation.
- Standard81 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1. The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable. The process described in this document is not intended to apply to circumstances where the toxicological risk has been estimated by other means, such as: — constituents, excluding cohort of concern or excluded chemicals, that are present in or extracted from a medical device at an amount representative of patient exposure below a relevant, toxicologically-based reporting threshold (see applicable requirements in ISO 10993-18:2020, Annex E and ISO/TS 21726); — a new or changed medical device for which chemical or biological equivalence has been established with an existing biocompatible or clinically established medical device (see applicable requirements in ISO 10993-18:2020, Annex C). The process described in this document is also not applicable to: — medical device constituents that do not contact the body (e.g. in vitro diagnostics); — biological risks associated with physical interactions of the medical device with the body (i.e. application of mechanical forces, energy or surface morphology, etc.), provided that the chemical exposure is not changed; — active pharmaceutical ingredients of device-drug combination products or biologic components of device-biologic combination products as additional regulatory considerations can apply; — exposure to a particular constituent that arises from sources other than the device, such as food, water or air.
- Standard65 pagesEnglish languagesale 15% off
- Standard69 pagesFrench languagesale 15% off
This document specifies general requirements for the design of tests for identifying and quantifying
degradation products from final metallic medical devices or corresponding material samples finished
as ready for clinical use.
This document is applicable only to those degradation products generated by chemical alteration of the
final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results
approximate the in vivo behaviour of the implant or material. The described chemical methodologies
are a means to generate degradation products for further assessments.
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 evaluation of degradation which occurs by purely mechanical
processes; methodologies for the production of this type of degradation product are described in
specific product standards, where available.
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the
scope of this document, such degradation products can evoke a biological response and can undergo biological
evaluation as described in other parts of ISO 10993.
Because of the wide range of metallic materials used in medical devices, no specific analytical
techniques are identified for quantifying the degradation products. The identification of trace elements
(<10–6 w/w) contained in the specific metal or alloy is not addressed in this document, nor are specific
requirements for acceptable levels of degradation products provided in this document.
This document excludes the biological activity of the degradation products. (See instead the applicable
clauses of ISO 10993-1 and ISO 10993-17).
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the framework and the methodology to evaluate and demonstrate the applicability of a validated non-animal method from an OECD test guideline to assess the skin sensitizing potential of a medical device or a medical device material. This document addresses: — the database of reference chemical skin sensitizers and non-skin sensitizers; — reference materials; — feasibility testing of candidate test methods, including any method optimization for use with extracts of medical devices; — prevalidation of candidate test methods; — the interlaboratory study: — sample preparation and coding; — spiking of the extracts from the negative control medical device material; — data collection; — statistical analysis to assess reliability and reproducibility. The use of the approaches described in this document to assess the applicability of a candidate test method does not imply that the candidate test method can be used as a stand-alone test for evaluating the skin sensitization potential of medical devices. For certain candidate test methods, integrated approaches and/or defined approaches are needed.[1] The evaluation of skin sensitization potential of a medical device is described in ISO 10993-10.
- Technical specification34 pagesEnglish languagesale 15% off
- Amendment13 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
- Standard60 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
— details of in vivo skin sensitization test procedures;
— key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
- Standard60 pagesEnglish languagesale 10% offe-Library read for1 day
This document describes the results of an international interlaboratory study conducted in 2006 to evaluate the performance of two different test protocols in terms of the cytotoxic effects in the biological evaluation of medical devices. The results of these tests were used for the revision of ISO 10993-5.[2] Furthermore, the results of these tests were used to estimate the accuracy of these test systems with living cells to define a threshold what is considered a cytotoxic effect. NOTE The determination of cytotoxic effects has a high relevance in the biological evaluation of medical devices; according to ISO 10993-1[1], it is one of the very few tests which are proposed to be performed for every kind of device.
- Technical report23 pagesEnglish languagesale 15% off
- Technical report23 pagesEnglish languagesale 15% off
- Technical report23 pagesEnglish languagesale 15% off
This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.
This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.
This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.
- Standard15 pagesEnglish languagesale 15% off
- Standard17 pagesFrench languagesale 15% off
2021-12-09- JO- the EN was submitted to FV wiith the link to the legislation (90/385/EEC, 93/42/EEC)
however since these legilsations have been repealed, the link has been removed and the EN is to proceed to publication
- Amendment11 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
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 evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993.
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist oral anticoagulation therapy, including performance, quality assurance and user training and procedures for the validation of performance by the intended users under actual and simulated conditions of use. This document applies solely to prothrombin time measuring systems used by lay persons for monitoring their own vitamin-K antagonist oral anticoagulation therapy, and which report results as international normalized ratios (INR). This document 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 document is not applicable to: — in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist oral anticoagulation therapy used by physicians or healthcare providers; — non-vitamin-K antagonist oral anticoagulation therapy (e.g. dabigatran); — a comprehensive evaluation of all possible factors that can affect the performance of these systems; — the medical aspects of oral-anticoagulation therapy.
- Standard53 pagesEnglish languagesale 15% off
This document establishes acceptable performance criteria for antimicrobial susceptibility test
(AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to
antimicrobial agents in medical laboratories.
This document specifies requirements for AST devices and procedures for assessing performance of
such devices. It defines how a performance evaluation of an AST device is to be conducted.
This document has been developed to guide manufacturers in the conduct of performance evaluation
studies.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
2021-12-09- JO- the EN was submitted to FV wiith the link to the legislation (90/385/EEC, 93/42/EEC)
however since these legilsations have been repealed, the link has been removed and the EN is to proceed to publication
- Amendment11 pagesEnglish languagesale 10% offe-Library read for1 day
This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories.
This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted.
This document has been developed to guide manufacturers in the conduct of performance evaluation studies.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 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 requirements for, reference materials;
— preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories. This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. This document has been developed to guide manufacturers in the conduct of performance evaluation studies.
- Standard16 pagesEnglish languagesale 15% off
- Standard16 pagesEnglish languagesale 15% off
- Standard18 pagesFrench languagesale 15% off
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 evaluation of degradation which occurs by purely mechanical processes; methodologies for the
production of this type of degradation product are described in specific product standards, where
available;
NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from
the scope of this document, such degradation products can evoke a biological response and can undergo
biological evaluation as described in other parts of ISO 10993.
b) leachable components which are not degradation products;
c) medical devices or components that do not contact the patient's body directly or indirectly
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: — details of in vivo skin sensitization test procedures; — key factors for the interpretation of the results. NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
- Standard48 pagesEnglish languagesale 15% off
- Standard48 pagesEnglish languagesale 15% off
- Standard51 pagesFrench languagesale 15% off
- Standard51 pagesFrench languagesale 15% off
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 test procedures;
— key factors for the interpretation of the results.
- Standard76 pagesEnglish languagesale 10% offe-Library read for1 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 requirements for, reference materials;
— preparation of extracts.
This document is not applicable to live cells but can be relevant to the material or medical device
components of combination products containing live cells.
Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the
exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization.
Information given in C.1 to C.4 can also be relevant.
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the principles and methods for pyrogen testing of medical devices and their materials.
- Technical report16 pagesEnglish languagesale 15% off
- Technical report16 pagesEnglish languagesale 15% off
- Technical report17 pagesFrench languagesale 15% off
- Technical report17 pagesFrench languagesale 15% off
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 the medical device;
— the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:
— the patient's body during intended use;
— the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).
This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
— breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
- Standard50 pagesEnglish languagesale 10% offe-Library read for1 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 the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.
- Standard37 pagesEnglish languagesale 10% offe-Library read for1 day
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 animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production of medical devices.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 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.
- Standard76 pagesEnglish languagesale 10% offe-Library read for1 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
— protect the rights, safety and well-being of human subjects,
— ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
— define the responsibilities of the sponsor and principal investigator, and
— assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.
NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.
- Standard96 pagesEnglish languagesale 10% offe-Library read for1 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 the medical
device;
— the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct
or indirect contact with:
— the patient's body during intended use;
— the user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and
others).
This document is applicable to biological evaluation of all types of medical devices including active,
non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
— risks, such as changes to the medical device over time, as a part of the overall biological safety
assessment;
— breakage of a medical device or medical device component which exposes body tissue to new or
novel materials.
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Devicespecific
or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform
encephalopathy (TSE) agents and other pathogens.
- Standard50 pagesEnglish languagesale 10% offe-Library read for1 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 requirements for, reference materials; — preparation of extracts. This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells. Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.
- Standard21 pagesEnglish languagesale 15% off
- Standard21 pagesEnglish languagesale 15% off
- Standard22 pagesFrench languagesale 15% off
- Standard22 pagesFrench languagesale 15% off
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 test procedures; — key factors for the interpretation of the results.
- Standard60 pagesEnglish languagesale 15% off
- Standard60 pagesEnglish languagesale 15% off
- Standard62 pagesFrench languagesale 15% off
- Standard62 pagesFrench languagesale 15% off
- Standard62 pagesFrench languagesale 15% off
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 materials of construction via the identification and quantification of their chemical constituents (material composition);
— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
- Standard81 pagesEnglish languagesale 10% offe-Library read for1 day
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 animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats. This document does not cover the utilization of human tissues in medical devices. This document does not specify a quality management system for the control of all stages of production of medical devices.
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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 the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing transmissible spongiform encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids. This document does not specify a quality management system for the control of all stages of production of medical devices. This document does not cover the utilization of human tissues in medical devices. NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. NOTE 2 For guidance on the application of this document, see Annex A.
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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 — protect the rights, safety and well-being of human subjects, — ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, — define the responsibilities of the sponsor and principal investigator, and — assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply. NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD. This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.
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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.
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NEXT ACTION: TC ACTION BY 2022-10-26 : TC to send a revised annex ZA for assessment at PUB
2020-02-19- JO-CEN/TC 206 to take decision either to remove the link or send a revised annex ZA for assessment at PUB
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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 document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, which are covered in ISO 10993‑9, ISO 10993‑13, ISO 10993‑14 and ISO 10993‑15. Chemical characterization of materials is covered by ISO 10993‑18. The ISO 10993 series is not applicable when the material or device is not in contact with the body directly or indirectly.
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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 materials of construction via the identification and quantification of their chemical constituents (material composition); — the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues); — the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables); — the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables). This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact). This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
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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 evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993. b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly.
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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.
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This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a medical device. The TTC values in this document can be used for: — comparing to a maximum concentration of an identified or unidentified constituent in an extract (see ISO 10993-18); — supporting toxicological equivalence; — comparing to a maximum exposure dose estimate of an identified constituent (see ISO 10993-17). NOTE Constituent is defined in 3.1. ISO 10993-18 specifies how to convert TTC (µg/d) into a concentration (µg/ml). TTC is not applicable to constituents with adequate toxicity data for deriving a tolerable intake (TI) value (see ISO 10993-17). The TTC values established in this document are protective for carcinogens, systemic toxicants, and reproductive toxicants (see Clause 5). This document does not include TTC values for other biological endpoints assessed as part of the biological evaluation of a medical device, per ISO 10993-1, for example: — cytotoxicity; — irritation; — sensitization; — hemocompatibility; — material mediated pyrogenicity; — local effects that occur in tissues at the site of contact between a medical device and the body (e.g. the observations from implantation studies). The TTC values in this document do not apply to potential exposure via gas pathways of medical devices. For application of TTC for constituents present/released from these devices, see the ISO 18562 series. The TTC values presented in this document are not applicable for the safety assessment of cohort of concern (see 5.3).
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This document specifies test methods for the evaluation of biological effects of medical devices used in
dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect
contact with the patient's body.
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