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biological equipment

biological equipment, Total:73 items.

In the international standard classification, biological equipment involves: Vocabularies, Biology. Botany. Zoology, Analytical chemistry, Medical equipment, Pharmaceutics, Dentistry, Laboratory medicine, Construction materials, Technical drawings, Microbiology, Sugar. Sugar products. Starch, Plant and equipment for the food industry, Medical sciences and health care facilities in general, Sterilization and disinfection, Non-destructive testing.


Association Francaise de Normalisation, biological equipment

  • NF X42-202:1987 BIOTECHNOLOGY. CENTRIFUGAL EQUIPMENT. DEFINITIONS AND CLASSIFICATION.
  • NF S99-501:1998 Biological evaluation of medical devices. Part 1 : evaluation and testing.
  • NF S99-502*NF EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2 : animal welfare requirements
  • NF S99-507:1996 Biological evaluation of medical devices. Part 7 : ethylene oxide sterilization residuals.
  • NF S99-518:2005 Biological evaluation of medical devices - Part 18 : chemical characterization of materials.
  • NF S99-511:2007 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity.
  • NF S99-511:1996 Biological evaluation of medical devices. Part 11 : tests for systemic toxicity.
  • NF S99-506:1995 Biological evaluation of medical devices. Part 6 : tests for local effects after implantation.
  • NF S99-503:1994 Biological evaluation of medical devices. Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity.
  • NF S92-051/A1*NF EN 12322/A1:2002 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
  • NF S92-051*NF EN 12322:1999 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media.
  • NF S91-224:1998 Dentistry. Preclinical evaluation of biocompatibility of medical devices used in dentistry. Test methods for dental materials.
  • NF S92-021*NF EN ISO 17511:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
  • NF S99-516:1997 Biological evaluation of medical devices. Part 16 : toxicokinetic study design for degradation products and leachables.
  • NF S92-022*NF EN ISO 18153:2004 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials.
  • NF S92-019*NF EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures

Taiwan Provincial Standard of the People's Republic of China, biological equipment

  • CNS 13382-18-1995 Implants for Surgery-Biocompatibility-Selection of Biological Test Methods for Materials and Devices
  • CNS 13382.18-1995 Implants for Surgery-Biocompatibility-Selection of Biological Test Methods for Materials and Devices
  • CNS 14393-11-2005 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • CNS 14393-1-2004 Biological evaluation of medical devices – Part 1:Evaluation and testing
  • CNS 14393.1-2004 Biological evaluation of medical devices – Part 1:Evaluation and testing
  • CNS 14393.11-2005 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • CNS 14393-2-2004 Biological evaluation of medical devices — Part 2:Animal welfare requirements
  • CNS 14393.2-2004 Biological evaluation of medical devices — Part 2:Animal welfare requirements
  • CNS 14393.12-2005 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
  • CNS 14393-12-2005 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
  • CNS 14393.7-2005 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • CNS 14393-7-2005 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • CNS 14393-5-2004 Biological evaluation of medical devices – Part 5:Tests for in vitro cytotoxicity
  • CNS 14393-13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
  • CNS 14393.13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
  • CNS 14393.8-2005 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
  • CNS 14393-8-2005 Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
  • CNS 14393.5-2004 Biological evaluation of medical devices – Part 5:Tests for in vitro cytotoxicity
  • CNS 14393.14-2005 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
  • CNS 14393-14-2005 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
  • CNS 14393.6-2004 Biological evaluation of medical devices - Part 6:Tests for local effects after implantation
  • CNS 14393-6-2004 Biological evaluation of medical devices - Part 6:Tests for local effects after implantation
  • CNS 14393-10-2005 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
  • CNS 14393.10-2005 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
  • CNS 14393-3-2004 Biological evaluation of medical devices – Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CNS 14393.3-2004 Biological evaluation of medical devices – Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • CNS 14393-15-2006 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
  • CNS 14393.9-2005 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • CNS 14393-9-2005 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
  • CNS 14393.4-2004 Biological evaluation of medical devices – Part 4:Selection of tests for interactions with blood
  • CNS 14393-4-2004 Biological evaluation of medical devices – Part 4:Selection of tests for interactions with blood
  • CNS 14393-16-2006 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

U.S. Military Regulations and Norms, biological equipment

ZA-SANS, biological equipment

  • SANS 10993-11:2008 Biological evaluation of medical devices Part 11: Tests for systemic toxicity

German Institute for Standardization, biological equipment

  • DIN 13279:2022 Biotechnology - Requirements for sample containers for storing biological materials in biobanks
  • DIN 13279:2022-05 Biotechnology - Requirements for sample containers for storing biological materials in biobanks

RU-GOST R, biological equipment

  • GOST 27543-1987 Confectionery. Equipment, materials, reagents and culture media for microbiological analyses

国家食品药品监督管理局, biological equipment

  • YY/T 1532-2017 Medical device biological evaluation nanomaterials hemolysis test
  • YY/T 1562-2017 Guidelines for Cell Activity Testing of Biomaterial Scaffolds for Tissue Engineering Medical Device Products
  • YY/T 1616-2018 Performance and Testing Guidelines for Biomaterial Scaffolds for Tissue Engineering Medical Device Products

Group Standards of the People's Republic of China, biological equipment

  • T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices

British Standards Institution (BSI), biological equipment

  • PD ISO/TR 10993-22:2017 Biological evaluation of medical devices. Guidance on nanomaterials
  • BS EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Determination of a population of microorganisms on products
  • PD ISO/TS 10993-19:2020 Biological evaluation of medical devices. Physico-chemical, morphological and topographical characterization of materials

American Society for Testing and Materials (ASTM), biological equipment

  • ASTM F1251-89(2003) Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
  • ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
  • ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

Professional Standard - Medicine, biological equipment

  • YY/T 1295-2015 Biological evaluation of medical devices.Nanomaterial: Endotoxin test
  • YY/Y 1576-2017 Implantation Test of Absorbable Biomaterials for Tissue Engineering Medical Devices

VN-TCVN, biological equipment

  • TCVN 7391-18-2007 Biological evaluation of medical devices.Part 18: Chemical characterization of materials

TH-TISI, biological equipment

  • TIS 2395.18-2008 Biological evaluation of medical devices.part 18: chemical characterization of materials

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, biological equipment

  • GB/T 16886.18-2011 Biological evaluation of medical devices.Part 18: Chemical characterization of materials

American National Standards Institute (ANSI), biological equipment

  • ANSI/AAMI BE83-2006 Biological evaluation of medical devices - Part 18: Chemical characterization of materials

Korean Agency for Technology and Standards (KATS), biological equipment





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