Category Archives: Biological evaluation of medical devices

BS EN ISO 10993-15:2001 – Biological evaluation of medical devices. Identification and quantification of degradation products from metals and alloys

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 24 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Medical equipment, Biological analysis and testing, Medical instruments, Metals, Alloys, Deterioration, Degradation, Accelerated corrosion tests, Chemical analysis and testing, Chemical reactions, Physico-chemical methods
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BS EN ISO 10993-1:2003 – Biological evaluation of medical devices. Evaluation and testing

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 26 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Medical equipment, Biological analysis and testing, Medical instruments, Medical technology, Biological hazards, Dental equipment, Dental materials, Implants (surgical), Therapeutics, Clinical investigation instruments, Bioassay, Cytotoxicity tests, Contaminants, Compatibility
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BS EN ISO 10993-4:2002 – Biological evaluation of medical devices. Selection of tests for interactions with blood

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 48 pages, A4

Manufacturer – BSI

Price – GBP 150

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Keywords – Medical equipment, Biological analysis and testing, Medical instruments, Medical technology, Blood, Biological hazards, Dental equipment, Dental materials
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BS EN ISO 10993-7:2008 – Biological evaluation of medical devices. Ethylene oxide sterilization residuals

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 98 pages, A4

Manufacturer – BSI

Price – GBP 170

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Keywords – Medical equipment, Biological analysis and testing, Sterile equipment, Sterilization (hygiene), Ethylene oxide, Dose (drug), Conformity, Formulae (mathematics), Safety measures, Factor of safety, Biological hazards, Chemical hazards, Sampling methods, Determination of content, Extraction methods of analysis, Temperature, Aqueous extraction methods, Solvent extraction methods, Gas chromatography, Chemical analysis and testing, Standard solutions, Precision, Testing conditions, Calibration
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08/30116059 DC – BS ISO 14155. Clinical investigation of medical devices for human subjects. Good clinical practice

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 61 pages, A4

Manufacturer – BSI

Price – GBP 20

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Keywords – Medical equipment, Clinical testing, People, Performance, Performance testing, Equipment safety, Risk assessment, Documents, Clinical investigation instruments, Diagnosis (medical), Reproducibility
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DD ISO/TS 10993-20:2006 – Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 26 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Medical equipment, Biological analysis and testing, Immunology, Toxicity, Toxicology, Immunologic diseases, Allergies, Autoimmune diseases, Risk assessment, Biological hazards, Identification methods
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08/30156451 DC – BS EN ISO 10993-13. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 25 pages, A4

Manufacturer – BSI

Price – GBP 20

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Keywords – Medical equipment, Biological analysis and testing, Biology, Degradation, Accelerated testing, Deterioration, Decomposition reactions, Identification methods, Quantitative analysis, Polymers, Testing conditions
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08/30187781 DC – BS EN ISO 10993-16. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 21 pages, A4

Manufacturer – BSI

Price – GBP 20

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Keywords – Medical equipment, Biological analysis and testing, Toxicology, Toxicity, Degradation, Design, Metabolism, Absorption, Decomposition reactions, Bibliography
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BS EN ISO 10993-13:1999 – Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 22 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Medical equipment, Biological analysis and testing, Biology, Degradation, Accelerated testing, Deterioration, Decomposition reactions, Identification methods, Quantitative analysis, Polymers, Testing conditions
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BS EN ISO 10993-14:2001 – Biological evaluation of medical devices. Identification and quantification of degradation products from ceramics

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 26 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Medical equipment, Biological analysis and testing, Chemical analysis and testing, Biology, Degradation, Accelerated testing, Deterioration, Decomposition reactions, Identification methods, Quantitative analysis, Ceramics, Glass ceramics
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BS EN ISO 10993-17:2002 – Biological evaluation of medical devices. Establishment of allowable limits for leachable substances

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 36 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Medical equipment, Biological analysis and testing, Leaching, Risk assessment, Toxic materials, Safety measures, Hazards
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BS EN ISO 20776-1:2006 – Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 32 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Diagnosis (medical), Clinical testing, Laboratory testing, Clinical medicine, Microorganisms, Pathogens, Biological hazards, Biological analysis and testing, Drugs, Antibiotics, Bacteria, Aerobic bacteria, Testing conditions, Dilution
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BS EN ISO 20776-2:2007 – Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial susceptibility test devices

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages, A4

Manufacturer – BSI

Price – GBP 72

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Keywords – Diagnosis (medical), Clinical testing, Laboratory testing, Clinical medicine, Microorganisms, Pathogens, Biological hazards, Biological analysis and testing, Drugs, Antibiotics, Bacteria, Testing conditions, Performance testing
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BS EN ISO 22442-1:2007 – Medical devices utilizing animal tissues and their derivatives. Application of risk management

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 38 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Animal products, Animals, Medical equipment, Medical sciences, Hazards, Biological hazards, Risk assessment, Management
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BS EN ISO 22442-2:2007 – Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 28 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Animal products, Animals, Medical equipment, Medical sciences, Cells (biology), Animal freight, Storage, Acceptance (approval), Environmental health, Inspection, Bovine animals, Veterinary science, Quality control
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BS EN ISO 22442-3:2007 – Medical devices utilizing animal tissues and their derivatives. Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 34 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Animal products, Animals, Medical equipment, Medical sciences, Verification, Sterilization (hygiene), Animal viruses, Viruses, Biological hazards, Microbiology, Microbiological analysis, Research, Technical documents, Mathematical calculations
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BS EN ISO 10993-10:2002 – Biological evaluation of medical devices. Tests for irritation and delayed-type hypersensitivity

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 62 pages, A4

Manufacturer – BSI

Price – GBP 160

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Keywords – Medical equipment, Biological analysis and testing, Human biology, Human body, Allergies
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BS EN ISO 10993-3:2003 – Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 28 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Medical equipment, Biological analysis and testing, Medical instruments, Dental equipment, Biological hazards, Toxic materials, Toxicity, Genotoxicity tests, Cytotoxicity tests
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BS EN ISO 10993-18:2005 – Biological evaluation of medical devices. Chemical characterization of materials

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 30 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Medical equipment, Biological analysis and testing, Chemical composition, Chemical properties, Equipment safety, Quality assurance, Conformity, Metals, Alloys, Ceramics, Polymers, Identification methods, Safety measures, Health and safety requirements
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DD ISO/TS 10993-19:2006 – Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 24 pages, A4

Manufacturer – BSI

Price – GBP 64

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Keywords – Medical equipment, Biological analysis and testing, Physical chemistry, Chemical properties, Contour, Shape, Surfaces, Safety measures, Health and safety requirements, Identification methods, Medical instruments
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BS EN ISO 10993-2:2006 – Biological evaluation of medical devices. Animal welfare requirements

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 24 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Medical equipment, Biological analysis and testing, Laboratory testing, Laboratory techniques, Surgery, Laboratory animals, Animals, Animal welfare, Testing conditions, Test specimens, Personnel, Laboratory workers, Planning
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BS EN ISO 10993-11:2006 – Biological evaluation of medical devices. Tests for systemic toxicity

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 38 pages, A4

Manufacturer – BSI

Price – GBP 130

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Keywords – Medical equipment, Biological analysis and testing, Medical instruments, Biological hazards, Toxic materials, Toxicology, Pathology, Diagnosis (medical), Bioassay, Test specimens, Specimen preparation, Toxicity
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08/30170164 DC – BS EN ISO 10993-10. Biological evaluation of medical devices. Part 10. Tests for irritation and skin sensitization

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 81 pages, A4

Manufacturer – BSI

Price – GBP 20

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Keywords – Medical equipment, Biological analysis and testing, Human biology, Human body, Allergies
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BS EN ISO 10993-5:1999 – Biological evaluation of medical devices. Tests for in vitro cytotoxicity

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Medical equipment, Biological analysis and testing, Cytotoxicity tests, Toxicity, Laboratory testing, Culture techniques, Cells (biology), Bioassay, Test specimens, Specimen preparation, Testing conditions, Test equipment, Extraction methods of analysis, Solvent extraction methods, Dental materials, Dental equipment
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BS EN ISO 10993-9:1999 – Biological evaluation of medical devices. Framework for identification and quantification of potential degradation products

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 18 pages, A4

Manufacturer – BSI

Price – GBP 80

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Keywords – Medical equipment, Biological analysis and testing, Chemical analysis and testing, Biological hazards, Degradation, Biodegradability, Leaching, Deterioration, Migration (chemical), Design, Experimental design, Reports
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BS EN ISO 10993-12:2007 – Biological evaluation of medical devices. Sample preparation and reference materials

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 30 pages, A4

Manufacturer – BSI

Price – GBP 114

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Keywords – Medical equipment, Biological analysis and testing, Test specimens, Specimen preparation, Control samples, Extraction, Selection, Extraction methods of analysis
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BS EN ISO 10993-6:2007 – Biological evaluation of medical devices. Tests for local effects after implantation

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 34 pages, A4

Manufacturer – BSI

Price – GBP 118

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Keywords – Medical equipment, Biological analysis and testing, Medical instruments, Medical technology, Biological hazards, Dental materials, Implants (surgical), Tissue implantation tests, Histology, Compatibility, Degradation, Biodegradability, Test specimens, Specimen preparation, Testing conditions, Laboratory animals
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BS EN ISO 10993-16:1997 – Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables

Available as PDF document for immediate download, or as printed publication – yes

Number of pages – 20 pages, A4

Manufacturer – BSI

Price – GBP 80

CLICK HERE FOR MORE INFORMATION

Keywords – Medical equipment, Biological analysis and testing, Toxicology, Toxicity, Degradation, Design, Metabolism, Absorption, Decomposition reactions, Bibliography
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