11.220 - Veterinary medicine
ICS 11.220 Details
Veterinary medicine
Veterinarmedizin
Medecine veterinaire
Veterinarstvo
General Information
Frequently Asked Questions
ICS 11.220 is a classification code in the International Classification for Standards (ICS) system. It covers "Veterinary medicine". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 76 standards classified under ICS 11.220 (Veterinary medicine). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document specifies the control and approval of in vitro diagnostic reagents used in animal health for immunological analyses with a qualitative expression of test results.
This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials (RMs).
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
- Standard15 pagesEnglish languagee-Library read for1 day
This document specifies terms and definitions applicable to the EN 18000 series and requirements concerning information to be provided by applicants submitting animal health in vitro diagnostic reagents to control.
This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials (RMs).
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies terms and definitions applicable to the EN 18000 series and requirements concerning information to be provided by applicants submitting animal health in vitro diagnostic reagents to control.
This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials (RMs).
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
- Standard32 pagesEnglish languagee-Library read for1 day
This document specifies the control and approval of in vitro diagnostic reagents used in animal health for immunological analyses with a qualitative expression of test results.
This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials (RMs).
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
- Standard15 pagesEnglish languagee-Library read for1 day
This document specifies a test method and the minimum requirements for mycobactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use-products - with water.
Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
This document is applicable to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying or flooding or other means and teat disinfection in the veterinary area - i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE This method corresponds to a phase 2 step 1 test.
- Standard35 pagesEnglish languagee-Library read for1 day
This document specifies a common data exchange format (i.e. format of the messages and the dictionary of all the items that compose the message) between the prescribers and the laboratories in the animal health sector.
This document is intended for prescribers (purchasers) and service providers in charge of collecting samples and conducting analyses (including laboratories) who are interested in computerizing and standardizing their data exchanges, particularly in the animal health sector.
This document excludes the code lists that are required for unambiguous data exchange.
- Standard53 pagesEnglish languagee-Library read for1 day
This document specifies a common data exchange format (i.e. format of the messages and the dictionary of all the items that compose the message) between the prescribers and the laboratories in the animal health sector.
This document is intended for prescribers (purchasers) and service providers in charge of collecting samples and conducting analyses (including laboratories) who are interested in computerizing and standardizing their data exchanges, particularly in the animal health sector.
This document excludes the code lists that are required for unambiguous data exchange.
- Standard53 pagesEnglish languagee-Library read for1 day
This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use-products - with water.
This document applies to products that are used in the veterinary area for disinfecting non-porous surfaces without mechanical action - i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances in the conditions in which they are used.
NOTE 2 This method corresponds to a Phase 2 Step 2 test.
This method excludes the evaluation of the activity of products against yeasts, fungal spores, mycobacteria and bacterial spores.
- Standard39 pagesEnglish languagee-Library read for1 day
This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water, or - in the case of ready-to-use-products - with water.
This European Standard applies to products that are used in the veterinary area on non-porous surfaces without mechanical action i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a Phase 2 Step 2 test.
NOTE 3 Using this European Standard, it is possible to determine the virucidal activity of the undiluted product.
NOTE 4 This standard uses Porcine Parvovirus because Bovine Enterovirus Type 1 (ECBO) virus used in the suspension test EN 14675 cannot be used for surface testing because of its loss of titre during drying. Porcine
Parvovirus has comparable resistance to ECBO virus.
- Standard36 pagesEnglish languagee-Library read for1 day
This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use-products - with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
This document applies to products that are used in the veterinary area - i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry. This document also applies to products used for teat disinfection.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 1 test.
- Standard48 pagesEnglish languagee-Library read for1 day
This procedure specifies a test method and the minimum requirements for bactericidal activity of teat disinfectants that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.
This method applies to teat disinfectants that are used in the veterinary area on teat skin without mechanical action as pre-milking and/or post-milking teat disinfectants.
NOTE 1 The method described is intended to determine the activity of commercial formulations under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 2 test.
NOTE 3 Two types of synthetic skin were assessed in a ring trial with no significant difference in performance. Other synthetic skins may become available and may be used if it can be shown that they give comparable results to the two referenced in this standard.
- Standard27 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
3.1 This practice pertains to all forms of toxicological testing (acute, subchronic, or chronic) performed by any route of administration (inhalation, oral, dermal, ocular, or other).
3.2 The U.S. Environmental Protection Agency, Good Laboratory Practices for Nonclinical Laboratory Studies, as listed in 40 CFR, requires that a testing facility maintain specific standard operating procedures (SOPs) including an SOP covering clinical observations in test animals.
3.3 This practice serves as a basis for consistency in clinical observations and is not meant to serve as a comprehensive list of observations that may be observed. Actual procedures and forms to be used in recording observations must be described in individual study protocols.
SCOPE
1.1 This practice describes the terms used in observing and recording cutaneous, gastrointestinal, respiratory, reproductive, neuromuscular, ocular, and general clinical signs of animals undergoing toxicological testing. This practice also assists in properly observing and assessing laboratory animals for signs of disease or adverse effects of compound administration.
1.2 This practice includes codes and descriptions for a wide variety of clinical signs, anatomical locations, and other descriptive qualifiers, and a technique for scoring the extent or severity of clinical signs.
1.3 This practice assumes that the reader is knowledgeable in animal toxicology and related pertinent areas and is trained in making clinical observations.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard9 pagesEnglish languagesale 15% off
- Standard9 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers the performance requirements for general-purpose air incubators ordinarily used for incubating procedures. It is applicable to gravity and forced ventilation incubators designed to operate over a specified range of temperature. This specification does not include any requirements for the safe handling of harmful or disease bearing organisms. Temperature uniformity within a specified period of time shall be tested using several thermocouples.
SCOPE
1.1 This specification covers the performance requirements for general purpose air incubators ordinarily used for incubating procedures, which have an incubating chamber up to 0.6 m3 (25 ft3) in volume. It is applicable to gravity and forced ventilation incubators designed to operate over all or part of the temperature range from 5 °C above ambient to 75 °C.
1.2 This specification does not include any requirements for the safe handling of harmful or disease bearing organisms.
1.3 The following precautionary caveat pertains only to the test method portions, Sections 4, 5, and 6, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Technical specification2 pagesEnglish languagesale 15% off
This document describes general workflows and protocols for the validation and the verification of qualitative screening tests for the detection of residues of veterinary drugs in liquid milk (raw, pasteurized, UHT and reconstituted milk powders and whey protein extracts) including biological methods. This guideline does not cover the validation of residue analysis by HPLC, UHPLC or LC-MS/MS.
This document is intended to be useful for manufacturers of screening test kits, laboratories validating screening methods or tests, competent authorities and dairies or end users of reagents or tests for the detection of veterinary drug residues in milk products. This document facilitates and improves the validation and verification of screening methods. The goals of this document are a harmonization in validation of methods or test kits in order for all stakeholders to have full trust in the result of residue screening and to limit the overlap and multiplication of validation work in different laboratories by sharing the validation results generated by an independent laboratory. Furthermore, a harmonized validation and verification procedure allows for comparison of the performance of different screening methods.
This document does not imply that all end users are bound to perform all verification work proposed.
The verification of the correct use of reagents/kits for the detection of antimicrobials is not part of the scope of this document.
- Technical specification42 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 This practice is intended to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.
4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
4.3 The only limitation applicable is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description of this limitation.
SCOPE
1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices.
1.2 The liquids injected into the mouse are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to evaluate any irritation caused by device materials by gross assessment.
4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of this practice in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
Note 1: Some materials (e.g., absorbables) may result in an extract pH (e.g., ≤2.0 or ≥11.5) that cannot be used with this practice.
4.3 The only applicable limitation is the extract preparation. Refer to Section 4.3 of Practice F619 for a description of this limitation.
SCOPE
1.1 This practice is an intracutaneous reactivity test used to assess the potential of the material under test to produce irritation following intradermal injections of extracts of the material.
1.2 The liquids injected into the rabbits are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.4 The values stated in SI units, including units officially accepted for use with the SI, are to be regarded as standard. No other systems of measurement are included in this standard.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectants and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.
This European Standard applies to products that are used in the veterinary area on porous surfaces without mechanical action i.e. in the breeding, husbandry, production, !veterinary care facilities", transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 2 test.
NOTE 3 This method cannot be used to evaluate the activity of products against mycobacteria or bacterial spores.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. This document applies to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and teat disinfection in the veterinary area - e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry. This document also applies to products used for teat disinfection in these veterinary areas.
This method is not applicable to evaluate the activity of hand hygiene products. For these products reference is made to EN 14885, which specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE This method corresponds to a phase 2 step 1 test.
- Standard40 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 In selecting a new material for human contact in medical applications, it is important to ensure that the material will not stimulate the immune system to produce an allergic reaction. The reaction would be due to substances which could leach out of a material. Therefore, this practice provides for using material extracts. The rationale for this practice is based on the fact that the guinea pig has been shown to be the best animal model for human allergic contact dermatitis. The use of Freund’s complete adjuvant and sodium lauryl sulfate tends to enhance the potential of a material to cause an allergy. Therefore, this test, while not guaranteeing that a material is nonallergenic, is the most severe animal test in common use today.
SCOPE
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
6.1 Explicit consideration of landscape features to characterize the quality of habitat for assessment species can enhance the ecological relevance of an EcoRA. This can help avoid assessing exposure in areas in which a wildlife species would be absent because of a lack of habitat or to bound exposure estimates in areas with low habitat quality. The measure of habitat quality is used in place of the commonly used Area Use Factor (AUF). Greater ecological realism and more informed management decisions can be realized through better use of landscape features to characterize sites.
SCOPE
1.1 Ecological Risk Assessments (EcoRAs) typically focus on valued wildlife populations. Regulatory authority for conducting EcoRAs derives from various federal laws [for example, Comprehensive Environmental Response, Compensation and Liability Act 1981, (CERCLA), Resource Conservation Recovery Act (RCRA), and Federal Insecticide, Fungicide, and Rodenticide Act, (FIFRA)]. Certain procedures for conducting EcoRAs (1-4)2 have been standardized [E1689-95(2003) Standard Guide for Developing Conceptual Site Models for Contaminated Sites; E1848-96(2003) Standard Guide for Selecting and Using Ecological Endpoints for Contaminated Sites; E2020-99a Standard Guide for Data and Information Options for Conducting an Ecological Risk Assessment at Contaminated Sites; E2205/E2205M-02 Standard Guide for Risk-Based Corrective Action for Protection of Ecological resources; E1739-95(2002) Standard Guide for Risk-Based Corrective Action Applied at Petroleum Release Sites]. Specialized cases for reporting data have also been standardized [E1849-96(2002) Standard Guide for Fish and Wildlife Incident Monitoring and Reporting] as have sampling procedures to characterize vegetation [E1923-97(2003) Standard Guide for Sampling Terrestrial and Wetlands Vegetation].
1.2 Most states have enacted laws modeled after the federal acts and follow similar procedures. Typically, estimates of likely exposure levels to constituents of potential concern (CoPC) are compared to toxicity benchmark values or concentration-response profiles to establish the magnitude of risk posed by the CoPC and to inform risk managers considering potential mitigation/remediation options. The likelihood of exposure is influenced greatly by the foraging behavior and residence time of the animals of interest in the areas containing significant concentrations of the CoPC. Foraging behavior and residence time of the animals are related to landscape features (vegetation and physiognomy) that comprise suitable habitat for the species. This guide presents a framework for incorporating habitat quality into the calculation of exposure levels for use in EcoRAs.
1.3 This guide is intended only as a framework for using measures of habitat quality in species specific habitat suitability models to assist with the calculation of exposure levels in EcoRA. Information from published Habitat Suitability Index (HSI) models (5) is used in this guide. The user should become familiar with the strengths and limitations of any particular HSI model used in order to characterize uncertainty in the exposure assessment (5-7). For species that do not have published habitat suitability models, the user may elect to develop broad categorical descriptions of habitat quality for use in estimating exposure.
- Guide10 pagesEnglish languagesale 15% off
This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use-products - with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the veterinary area, i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
NOTE 1 The method described is intended to determine the virucidal activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 1.
- Standard34 pagesEnglish languagee-Library read for1 day
This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation in hard water or in the case of ready-to-use products with water.
This European Standard applies to products for use in the veterinary area i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a Phase 2 Step 2 test.
- Standard39 pagesEnglish languagee-Library read for1 day
This document specifies the control and approval of in vitro diagnostic reagents used in animal health for the detection, and/or absolute quantification of pathogen-specific nucleic acid (DNA or RNA) by PCR (e.g. endpoint PCR, real-time PCR, reverse transcription-PCR).
This document is applicable to diagnostic reagents as a priority for infectious diseases (due to bacteria, viruses, fungi, or parasites, including genetic markers associated with pathogenicity, such as antimicrobial resistance or toxin production) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. Anyhow, all reagents designated by the competent authorities fall under the scope of this document. Nevertheless, the authorities or any other animal health stakeholder can choose to derogate in specific and very limited situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials.
The PCR diagnosis usually involves the use of a nucleic acid extraction and/or purification reagent, and a PCR reagent. The PCR method (when applicable) involves the successive use of these distinct reagents. PCR reagent control can be performed if the applicant provides evidence of the validity of the PCR reagent for use in the animal health diagnostic analysis, by proving its diagnostic performances with nucleic acid extracts obtained from the different matrices described in the instruction for use. The control of a complete PCR method by the applicant and the control organization is performed only if the PCR reagent cannot be dissociated from an nucleic acid extraction and/or purification systems. This document does not cover the control of the nucleic acid extraction and/or purification reagents, only.
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
NOTE Prion diseases are not included in the scope of this third part of the EN 18000 series. Unlike other infectious diseases, prion diseases are not diagnosed using PCR assays because prions lack a nucleic acid component and consist solely of an abnormally folded conformer of the normal host protein.
- Draft22 pagesEnglish languagee-Library read for1 day
This document specifies the control and approval of in vitro diagnostic reagents used in animal health for the detection, and/or absolute quantification of pathogen-specific nucleic acid (DNA or RNA) by PCR (e.g. endpoint PCR, real-time PCR, reverse transcription-PCR).
This document is applicable to diagnostic reagents as a priority for infectious diseases (due to bacteria, viruses, fungi, or parasites, including genetic markers associated with pathogenicity, such as antimicrobial resistance or toxin production) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. Anyhow, all reagents designated by the competent authorities fall under the scope of this document. Nevertheless, the authorities or any other animal health stakeholder can choose to derogate in specific and very limited situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials.
The PCR diagnosis usually involves the use of a nucleic acid extraction and/or purification reagent, and a PCR reagent. The PCR method (when applicable) involves the successive use of these distinct reagents. PCR reagent control can be performed if the applicant provides evidence of the validity of the PCR reagent for use in the animal health diagnostic analysis, by proving its diagnostic performances with nucleic acid extracts obtained from the different matrices described in the instruction for use. The control of a complete PCR method by the applicant and the control organization is performed only if the PCR reagent cannot be dissociated from an nucleic acid extraction and/or purification systems. This document does not cover the control of the nucleic acid extraction and/or purification reagents, only.
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
NOTE Prion diseases are not included in the scope of this third part of the EN 18000 series. Unlike other infectious diseases, prion diseases are not diagnosed using PCR assays because prions lack a nucleic acid component and consist solely of an abnormally folded conformer of the normal host protein.
- Draft22 pagesEnglish languagee-Library read for1 day
This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. This document applies to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and teat disinfection in the veterinary area - e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry. This document also applies to products used for teat disinfection in these veterinary areas.
This method is not applicable to evaluate the activity of hand hygiene products. For these products reference is made to EN 14885, which specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE This method corresponds to a phase 2 step 1 test.
- Draft39 pagesEnglish languagee-Library read for1 day
This document specifies a test method and the minimum requirements for bactericidal activity of teat disinfectants that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - with water.
This method applies to teat disinfectants that are used on teat skin without mechanical action as pre-milking and/or post-milking teat disinfectants in the veterinary area, e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 2 test.
- Draft28 pagesEnglish languagee-Library read for1 day
This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water, or - in the case of ready-to-use-products - with water.
This European Standard applies to products that are used in the veterinary area on non-porous surfaces without mechanical action i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a Phase 2 Step 2 test.
NOTE 3 Using this European Standard, it is possible to determine the virucidal activity of the undiluted product.
NOTE 4 This standard uses Porcine Parvovirus because Bovine Enterovirus Type 1 (ECBO) virus used in the suspension test EN 14675 cannot be used for surface testing because of its loss of titre during drying. Porcine
Parvovirus has comparable resistance to ECBO virus.
- Draft6 pagesEnglish languagee-Library read for1 day
This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectants and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.
This European Standard applies to products that are used in the veterinary area on porous surfaces without mechanical action i.e. in the breeding, husbandry, production, transport, veterinary care facilities and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 2 test.
NOTE 3 This method cannot be used to evaluate the activity of products against mycobacteria or bacterial spores.
- Draft4 pagesEnglish languagee-Library read for1 day
ABSTRACT
This specification covers the performance requirements for general-purpose air incubators ordinarily used for incubating procedures. It is applicable to gravity and forced ventilation incubators designed to operate over a specified range of temperature. This specification does not include any requirements for the safe handling of harmful or disease bearing organisms. Temperature uniformity within a specified period of time shall be tested using several thermocouples.
SCOPE
1.1 This specification covers the performance requirements for general purpose air incubators ordinarily used for incubating procedures, which have an incubating chamber up to 0.6 m3 (25 ft3) in volume. It is applicable to gravity and forced ventilation incubators designed to operate over all or part of the temperature range from 5°C above ambient to 75°C.
1.2 This specification does not include any requirements for the safe handling of harmful or disease bearing organisms.
1.3 The following precautionary caveat pertains only to the test method portions, Sections 4, 5, and 6, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Technical specification2 pagesEnglish languagesale 15% off
- Technical specification2 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
3.1 This practice pertains to all forms of toxicological testing (acute, subchronic, or chronic) performed by any route of administration (inhalation, oral, dermal, ocular, or other).
3.2 The U.S. Environmental Protection Agency, Good Laboratory Practices for Nonclinical Laboratory Studies, as listed in 40 CFR, requires that a testing facility maintain specific standard operating procedures (SOPs) including an SOP covering clinical observations in test animals.
3.3 This practice serves as a basis for consistency in clinical observations. Actual procedures and forms to be used in recording observations must be described in individual study protocols.
SCOPE
1.1 This practice describes the terms used in observing and recording cutaneous, gastrointestinal, respiratory, reproductive, neuromuscular, ocular, and general clinical signs of animals undergoing toxicological testing. This practice also assists in properly observing and assessing laboratory animals for signs of disease or adverse effects of compound administration.
1.2 This practice includes codes and descriptions for a wide variety of clinical signs, anatomical locations, and other descriptive qualifiers, and a technique for scoring the extent or severity of clinical signs.
1.3 This practice assumes that the reader is knowledgeable in animal toxicology and related pertinent areas and is trained in making clinical observations.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard9 pagesEnglish languagesale 15% off
- Standard9 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 In selecting a new material for human contact in medical applications, it is important to ensure that the material will not stimulate the immune system to produce an allergic reaction. The reaction would be due to substances which could leach out of a material. Therefore, this practice provides for using material extracts. The rationale for this practice is based on the fact that the guinea pig has been shown to be the best animal model for human allergic contact dermatitis. The use of Freund’s complete adjuvant and sodium lauryl sulfate tends to enhance the potential of a material to cause an allergy. Therefore, this test, while not guaranteeing that a material is nonallergenic, is the most severe animal test in common use today.
SCOPE
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.
4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
4.3 The only applicable limitation is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description of this limitation.
SCOPE
1.1 This practice is a nonspecific, acute toxicity test used to help determine the biocompatibility of materials used in medical devices.
1.2 The liquids injected into the rabbits are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.
4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
4.3 The only applicable limitation is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description of this limitation.
SCOPE
1.1 This practice is a nonspecific, acute toxicity test used to help determine the biocompatibility of materials used in medical devices.
1.2 The liquids injected into the rabbits are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 In selecting a new material for human contact in medical applications, it is important to ensure that the material will not stimulate the immune system to produce an allergic reaction. The reaction would be due to substances which could leach out of a material. Therefore, this practice provides for using material extracts. The rationale for this practice is based on the fact that the guinea pig has been shown to be the best animal model for human allergic contact dermatitis. The use of Freund’s complete adjuvant and sodium lauryl sulfate tends to enhance the potential of a material to cause an allergy. Therefore, this test, while not guaranteeing that a material is nonallergenic, is the most severe animal test in common use today.
SCOPE
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This practice is intended to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.
4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
4.3 The only limitation applicable is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description of this limitation.
SCOPE
1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices.
1.2 The liquids injected into the mouse are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
- Standard3 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers the performance requirements for general-purpose air incubators ordinarily used for incubating procedures. It is applicable to gravity and forced ventilation incubators designed to operate over a specified range of temperature. This specification does not include any requirements for the safe handling of harmful or disease bearing organisms. Temperature uniformity within a specified period of time shall be tested using several thermocouples.
SCOPE
1.1 This specification covers the performance requirements for general purpose air incubators ordinarily used for incubating procedures, which have an incubating chamber up to 0.6 m3 (25 ft3) in volume. It is applicable to gravity and forced ventilation incubators designed to operate over all or part of the temperature range from 5°C above ambient to 75°C.
1.2 This specification does not include any requirements for the safe handling of harmful or disease bearing organisms.
The following precautionary caveat pertains only to the test method portions, Sections 4, 5, and 6, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Technical specification2 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
Explicit consideration of landscape features to characterize the quality of habitat for assessment species can enhance the ecological relevance of an EcoRA. This can help avoid assessing exposure in areas in which a wildlife species would be absent because of a lack of habitat or to bound exposure estimates in areas with low habitat quality. The measure of habitat quality is used in place of the commonly used Area Use Factor (AUF). Greater ecological realism and more informed management decisions can be realized through better use of landscape features to characterize sites.
SCOPE
1.1 Ecological Risk Assessments (EcoRAs) typically focus on valued wildlife populations. Regulatory authority for conducting EcoRAs derives from various federal laws [for example, Comprehensive Environmental Response, Compensation and Liability Act 1981, (CERCLA), Resource Conservation Recovery Act (RCRA), and Federal Insecticide, Fungicide, and Rodenticide Act, (FIFRA)]. Certain procedures for conducting EcoRAs (1-4) have been standardized [E1689-95(2003) Standard Guide for Developing Conceptual Site Models for Contaminated Sites; E1848-96(2003) Standard Guide for Selecting and Using Ecological Endpoints for Contaminated Sites; E2020-99a Standard Guide for Data and Information Options for Conducting an Ecological Risk Assessment at Contaminated Sites; E2205-02 Standard Guide for Risk-Based Corrective Action for Protection of Ecological resources; E1739-95(2002) Standard Guide for Risk-Based Corrective Action Applied at Petroleum Release Sites]. Specialized cases for reporting data have also been standardized [E1849-96(2002) Standard Guide for Fish and Wildlife Incident Monitoring and Reporting] as have sampling procedures to characterize vegetation [E1923-97(2003) Standard Guide for Sampling Terrestrial and Wetlands Vegetation].
1.2 Most states have enacted laws modeled after the federal acts and follow similar procedures. Typically, estimates of likely exposure levels to constituents of potential concern (CoPC) are compared to toxicity benchmark values or concentration-response profiles to establish the magnitude of risk posed by the CoPC and to inform risk managers considering potential mitigation/remediation options. The likelihood of exposure is influenced greatly by the foraging behavior and residence time of the animals of interest in the areas containing significant concentrations of the CoPC. Foraging behavior and residence time of the animals are related to landscape features (vegetation and physiognomy) that comprise suitable habitat for the species. This guide presents a framework for incorporating habitat quality into the calculation of exposure levels for use in EcoRAs.
1.3 This guide is intended only as a framework for using measures of habitat quality in species specific habitat suitability models to assist with the calculation of exposure levels in EcoRA. Information from published Habitat Suitability Index (HSI) models (5) is used in this guide. The user should become familiar with the strengths and limitations of any particular HSI model used in order to characterize uncertainty in the exposure assessment (5-7). For species that do not have published habitat suitability models, the user may elect to develop broad categorical descriptions of habitat quality for use in estimating exposure.
- Guide10 pagesEnglish languagesale 15% off
- Guide10 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
This practice pertains to all forms of toxicological testing (acute, subchronic, or chronic) performed by any route of administration (inhalation, oral, dermal, ocular, or other).
The U.S. Environmental Protection Agency, Good Laboratory Practices for Nonclinical Laboratory Studies, as listed in 40 CFR, requires that a testing facility maintain specific standard operating procedures (SOPs) including an SOP covering clinical observations in test animals.
This practice serves as a basis for consistency in clinical observations. Actual procedures and forms to be used in recording observations must be described in individual study protocols.
SCOPE
1.1 This practice describes the terms used in observing and recording cutaneous, gastrointestinal, respiratory, reproductive, neuromuscular, ocular, and general clinical signs of animals undergoing toxicological testing. This practice also assists in properly observing and assessing laboratory animals for signs of disease or adverse effects of compound administration.
1.2 This practice includes codes and descriptions for a wide variety of clinical signs, anatomical locations, and other descriptive qualifiers, and a technique for scoring the extent or severity of clinical signs.
1.3 This practice assumes that the reader is knowledgeable in animal toxicology and related pertinent areas and is trained in making clinical observations.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard9 pagesEnglish languagesale 15% off
SCOPE
1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices.
1.2 The liquids injected in the mouse are those obtained by Practice F 619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
- Standard3 pagesEnglish languagesale 15% off
SCOPE
1.1 This practice covers a procedure by which the irritancy of a biomaterial may be assessed through contact with abraded and intact skin of rabbits.
1.2 The results of this practice depend upon the effectiveness with which contact between skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard3 pagesEnglish languagesale 15% off
SCOPE
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and inexpensive method which, through use over the years, has become a generally accepted method.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a biomaterial may be assessed through contact with abraded and intact skin of rabbits.
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
This practice is intended to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.
This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F 748.
The only limitation applicable is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F 619 for a description of this limitation.
SCOPE
1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices.
1.2 The liquids injected into the mouse are those obtained by Practice F 619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
In selecting a new material for human contact in medical applications, it is important to ensure that the material will not stimulate the immune system to produce an allergic reaction. The reaction would be due to substances which could leach out of a material. Therefore, this practice provides for using material extracts. The rationale for this practice is based on the fact that the guinea pig has been shown to be the best animal model for human allergic contact dermatitis. The use of Freund’complete adjuvant and sodium lauryl sulfate tends to enhance the potential of a material to cause an allergy. Therefore, this test, while not guaranteeing that a material is nonallergenic, is the most severe animal test in common use today.
SCOPE
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard3 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.
This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F 748.
The only applicable limitation is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F 619 for a description of this limitation.
SCOPE
1.1 This practice is a nonspecific, acute toxicity test used to help determine the biocompatibility of materials used in medical devices.
1.2 The liquids injected into the rabbits are those obtained by Practice F 619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.4 The values stated in SI units are to be regarded as the standard.
- Standard3 pagesEnglish languagesale 15% off
SCOPE
1.1 This practice is a nonspecific, acute toxicity test used to help determine the biocompatibility of materials used in medical devices.
1.2 The liquids injected in the rabbits are those obtained by Practice F 619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
1.4 The values stated in SI units are to be regarded as the standard.
- Standard3 pagesEnglish languagesale 15% off
ABSTRACT
This specification covers the performance requirements for general-purpose air incubators ordinarily used for incubating procedures. It is applicable to gravity and forced ventilation incubators designed to operate over a specified range of temperature. This specification does not include any requirements for the safe handling of harmful or disease bearing organisms. Temperature uniformity within a specified period of time shall be tested using several thermocouples.
SCOPE
1.1 This specification covers the performance requirements for general purpose air incubators ordinarily used for incubating procedures, which have an incubating chamber up to 0.6 m3 (25 ft3) in volume. It is applicable to gravity and forced ventilation incubators designed to operate over all or part of the temperature range from 5°C above ambient to 75°C.
1.2 This specification does not include any requirements for the safe handling of harmful or disease bearing organisms.
The following precautionary caveat pertains only to the test method portions, Sections 4, 5, and 6, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Technical specification2 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
This guide provides guidelines for the selection of animal species, dosage and sampling conditions, sampling and scoring methods, statistical design, and analysis of genotoxicity assays in which the endpoint measured is the frequency of micronucleated erythrocytes in mammalian bone marrow.
SCOPE
1.1 This guide provides recommended guidelines for performing the mammalian in vivo bone marrow micronucleus assay. Under appropriate test conditions, measurement of the frequency of newly formed micronucleated erythrocytes in bone marrow provides a convenient index of chromosomal damage in nucleated erythrocyte precursor cells. The rationale for the occurrence of micronuclei in conjunction with chromosomal damage has been described previously (1). This guide describes conditions under which the frequency of micronucleated erythrocytes in mammalian bone marrow is an appropriate measure of in vivo chromosomal damage, and provides guidelines for the design and technical execution of assays employing this endpoint.
1.2 The following guidelines for mammalian bone marrow erythrocyte micronucleus assays have been published by organizations concerned with the evaluation of genotoxicity test data. These references should be consulted for recommendations on details not covered in depth by this guide and for requirements of specific organizations or government agencies (2-6).
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Guide7 pagesEnglish languagesale 15% off
SCOPE
1.1 This practice covers a typical procedure and guidelines for conducting the rat in vivo hepatocyte DNA repair assay. The procedures presented here are based on similar protocols that have been shown to be reliable (1, 2, 3, 4, 5).
1.2 Mention of trade names or commercial products are meant only as examples and not as endorsements. Other suppliers or manufacturers of equivalent products are acceptable.
1.3 This standard does not purport to address all of the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard8 pagesEnglish languagesale 15% off
SCOPE
1.1 This test method covers an inhalation procedure to investigate the cardiac sensitization of volatile chlorinated hydrocarbons and other volatile solvents.
1.2 This test method is primarily a screening tool. The procedure does permit a rank order of the sensitization potential of the compounds tested, but is not recommended for establishing significant effect levels.
1.3 This test method assumes that the user is knowledgeable in mammalian toxicology, electrocardiography with animals and other pertinent areas, and relies heavily on the judgment of the investigator.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
- Standard3 pagesEnglish languagesale 15% off