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ASTM - ASTM F1408 - STANDARD PRACTICE FOR SUBCUTANEOUS SCREENING TEST FOR IMPLANT MATERIALS Organization: ASTM
Date: 1997-11-10
Description:   This practice, along with other appropriate biological tests (including other ASTM test methods), may be used to assess the biocompatibility of candidate materials for use in the fabrication of devices for clinical application.
ASTM - ASTM F763 - STANDARD PRACTICE FOR SHORT-TERM SCREENING OF IMPLANT MATERIALS Organization: ASTM
Date: 2004-05-01
Description: This is a rapid screening procedure for determining acceptability of candidate materials. This practice, along with other appropriate biological tests (including other appropriate ASTM tests) may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.
ASTM - ASTM F1609 - STANDARD SPECIFICATION FOR CALCIUM PHOSPHATE COATINGS FOR IMPLANTABLE MATERIALS Organization: ASTM
Date: 2008-05-01
Description: In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response (1,2)2 and laboratory characterization (2- 4).
ASTM - ASTM F1439 - STANDARD GUIDE FOR PERFORMANCE OF LIFETIME BIOASSAY FOR THE TUMORIGENIC POTENTIAL OF IMPLANT MATERIALS Organization: ASTM
Date: 2003-11-01
Description:   Assessment of tumorigenicity is one of several procedures employed in determining the biological response to a material as recommended in Practice F748. It is assumed that the investigator has already determined that this type of testing is necessary for a particular material before consulting this guide.
ASTM - ASTM D7475 - STANDARD TEST METHOD FOR DETERMINING THE AEROBIC DEGRADATION AND ANAEROBIC BIODEGRADATION OF PLASTIC MATERIALS UNDER ACCELERATED BIOREACTOR LANDFILL CONDITIONS Organization: ASTM
Date: 2011-01-01
Description: This modification is a two-tiered test method in which the two tiers, which address aerobic degradation and anaerobic biodegradation, are most preferably run sequentially to more closely resemble the real world condition of a biologically active landfill, or a bioreactor landfill, but are functional independently and separately depending on the plastic under evaluation and the information sought: either aerobic degradation or anaerobic biodegradation or both.
ASTM - ASTM E1705 - STANDARD TERMINOLOGY RELATING TO BIOTECHNOLOGY Organization: ASTM
Date: 2015-06-01
Description: This standard includes terminology used in biotechnology areas, such as, but not limited to: biological drug products, materials for biotechnology, characterization and identification of biological systems, aseptic sampling, preservation of biological samples, membrane filters, molecular biology, biomass conversion, fuel manufacturing facilities, and fuel analysis.
ASTM - ASTM F619 - STANDARD PRACTICE FOR EXTRACTION OF MEDICAL PLASTICS Organization: ASTM
Date: 2014-03-01
Description: The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.
ASTM - ASTM F2721 - STANDARD GUIDE FOR PRE-CLINICAL IN VIVO EVALUATION IN CRITICAL SIZE SEGMENTAL BONE DEFECTS Organization: ASTM
Date: 2009-06-01
Description:   Other pre-clinical methods may also be appropriate and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.
ASTM - ASTM D4025 - STANDARD PRACTICE FOR REPORTING RESULTS OF EXAMINATION AND ANALYSIS OF DEPOSITS FORMED FROM WATER FOR SUBSURFACE INJECTION Organization: ASTM
Date: 2008-10-01
Description: NOTE 1—While reporting of inorganic constituents in water-formed deposits as specified in Test Methods D4412 is sufficient for certain industries, this practice provides for the reporting of organic and biological materials as well as inorganic constituents. NOTE 2—Consistent with practices in industries where subsurface injection of water is practiced, reporting includes specifying of inorganic constituents as probable molecular combinations of the species for which analyses are performed.
DSF/ISO/DIS 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES Organization: DS
Description: This International Standard specifies requirements and guidance for processing practices and managing risks associated with viable cellular component(s) of products regulated as medicinal products, biologics, medical devices and active implantable medical devices or combinations thereof.
DS/ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES Organization: DS
Date: 2012-04-27
Description: This International Standard specifies requirements and guidance for processing practices and managing risks associated with viable cellular component(s) of products regulated as medicinal products, biologics, medical devices and active implantable medical devices or combinations thereof.
ASTM - ASTM D5525 - STANDARD PRACTICE FOR EXPOSING PLASTICS TO A SIMULATED ACTIVE LANDFILL ENVIRONMENT Organization: ASTM
Date: 1994-06-15
Description: 1.2 Changes in the material properties of the plastic and controls should be determined using appropriate ASTM test procedures.
ASTM - ASTM F2884 - STANDARD GUIDE FOR PRE-CLINICAL IN VIVO EVALUATION OF SPINAL FUSION Organization: ASTM
Date: 2012-04-01
Description: Other pre-clinical methods may also be appropriate and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.
ASTM - ASTM F2451 - STANDARD GUIDE FOR IN VIVO ASSESSMENT OF IMPLANTABLE DEVICES INTENDED TO REPAIR OR REGENERATE ARTICULAR CARTILAGE Organization: ASTM
Date: 2005-04-01
Description: This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of product. ASTM standards for these steps are available in Reference Documents.
DSF/ISO/FDIS 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES Organization: DS
Description: This International Standard specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products, biologics, medical devices and active implantable medical devices, or combinations thereof.
DIN ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012) Organization: DIN
Date: 2014-06-01
Description: This International Standard specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products, biologics, medical devices and active implantable medical devices, or combinations thereof.
ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES - FIRST EDITION Organization: ISO
Date: 2012-04-01
Description: This International Standard specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products, biologics, medical devices and active implantable medical devices, or combinations thereof.
AAMI 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES Organization: AAMI
Date: 2012-01-01
Description: This International Standard specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products, biologics, medical devices and active implantable medical devices, or combinations thereof.
NBN - EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015) Organization: NBN
Date: 2015-11-30
Description: ISO 12417-1:2015 does not address issues associated with viable or non-viable biological materials such as tissues, cells, or proteins.ISO 12417-1:2015 does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).
NBN - EN ISO 12417-1 - IMPLANTS CARDIOVASCULAIRES ET CIRCUITS EXTRA-CORPORELS - PRODUITS DE COMBINAISON MÉDICAMENT-DISPOSITIF VASCULAIRE - PARTIE 1: EXIGENCES GÉNÉRALES (ISO 12417-1:2015) Organization: NBN
Date: 2015-11-30
Description: ISO 12417-1:2015 does not address issues associated with viable or non-viable biological materials such as tissues, cells, or proteins.ISO 12417-1:2015 does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).

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