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4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (1) polymerizable collagen starting materials; and (2) collagen polymeric materials produced with polymerizable collagen formulations, used for surgical implants,...
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the...
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the...
5.1 The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides...
1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems. 1.2 The...
This specification covers material requirements for chemical composition of anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium...
This part of ISO 12417 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an...
1.1 This standard specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral...
This specification covers the material requirements for calcium phosphate coatings for surgical implant applications. In particulate and monolithic form, the calcium phosphate materials system has been well-characterized regarding biological response and laboratory characterization....
4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (a) collagen polymers as a starting material for surgical implants, substrates for tissue-engineered medical products (TEMPs), vehicles for therapeutic cells and...
This guide for characterizing polymerizable collagens is intended to provide characteristics, properties, test methods, and standardization approaches for use by producers, manufacturers, and researchers to identify specific collagen polymer formulations and associated self-assembled collagenbased...
This guide describes recommended in vitro test procedures for coating inspection and acute particulate characterization of coated drug-eluting vascular (balloon-expandable and self-expanding) stent systems. Recommended practices for coating inspection and acute particulate...
The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides...
1.1 This specification covers nails, spikes, staples, and other driven fasteners, as listed in Table 1. TABLE 1 Classification and Identification Index Type Style Style Identification Table I-Nails (NL) 1. Brads BR 3 2. Barrel BL 4 3. Boat BTH/BTL 5 4. Box A BXA 6 Box B BXB 7 5. Broom BM 8 6....
1.1 This guide is an outline of methods for scanning electron microscopy (SEM) intended for use by forensic paint examiners. This guide is intended to supplement information presented in Guide E1610. 1.2 The methods used by each examiner or laboratory or both depend upon sample size, sample...
1.1 This part of ISO 25539 specifies requirements for vascular stents, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information...
This specification covers material requirements for chemical composition of anorganic xenogeneic or allogeneic bone (apatite) intended for surgical implants. This specification specifically excludes synthetic hydroxylapatite, hydroxylapatite coatings, ceramic glasses, tribasic calcium...
1.1 This International Standard specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information...
This part of ISO 25539 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied...
1.1 This Technical Specification specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as...
