Standards

Standards published in 2010:
Standard Title Publication Study Commission
ABNT NBR IEC 60601-2-50:2010 (REVIEW) Electromedical equipment — Part 2-50: — Particular requirements for basic safety and essential performance of phototherapy equipment 18/11/2010 020.01
ABNT NBR IEC 60601-2-39:2010 Electromedical equipment — Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment 17/11/2010 020.01
ABNT NBR 15891-1:2010 Implants for surgery – bioabsorbable resins – Part 1: Specifications for semi crystalline resins of polymers and copolymers of poly(lactic acid) 29/10/2010 070.01
ABNT NBR ISO 7206-2:1999 Errata 2:2010 Implants for surgery – Partial and total prosthetics of hip joints – Part 2: Joint surfaces made of metallic, ceramic and plastic material 28/10/2010 070.01
ABNT NBR ISO 7207-2:1998 Errata 1:2010 Implants for surgery — Femoral and tibial components for total and partial knee joint prosthetics — Part 2: Surfaces of joints made of metallic, ceramic and plastic materials 28/10/2010 070.01
ABNT NBR ISO 5832-1:2008 Errata 1:2010 Surgical implants – Metallic materials – Part 1: Conformed stainless steel 27/10/2010 070.01
ABNT NBR 13911:2010 Errata 1:2010 Surgical instruments – Metallic material– Specifications for conformed stainless steel 27/10/2010 070.01
ABNT NBR 15628-1:2010 Errata 1:2010 Implants for surgery — Metallic components — Part 1: Specifications for stainless steel 18-chromium 12.5-nickel 2.5 molybdenum welded and solubilized by annealing 27/10/2010 070.01
ABNT NBR 15628-3:2010 Errata 1:2010 Implants for surgery — Metallic components — Part 3: Specifications for forged in an alloy made of cobalt-28 chromium-6 molybdenum 27/10/2010 070.01
ABNT NBR 15628-5:2010 Implants for surgery — Metallic components — Part 5: Requirements for stainless steel forged 27/10/2010 070.01
ABNT NBR ISO 21535:2008 Errata 1:2010 Non-active surgical implants – Implants for joint replacement – Specific requirements for hip joint replacement implants 27/10/2010 070.01
ABNT NBR 15720-5:2010 Implants for orthopedics — Ceramic materials — Part 5: Specifications for hydroxyapatite 26/10/2010 070.01
ABNT NBR 15891-4:2010 Implants for surgery – bioabsorbable resins – Part 4: Test method for evaluation of in vitro degradation of hydrolytically degradable polymeric resins and manufactured shapes 26/10/2010 070.01
ABNT NBR 15892:2010 Implants for orthopedics – Non-destructive tests – Guidance for procedure and radiographic inspection of metallic components 26/10/2010 070.01
ABNT NBR 15893-1:2010 Implants for orthopedics – Metallic materials – Part 1: Specification for conformed stainless steel wires and bars with low nickel, 11-manganese, 17-chromium and 3-molybdenum, strengthened by nitrogen (UNS S29225) 26/10/2010 070.01
ABNT NBR 15893-2:2010 Implants for orthopedics – Metallic materials – Part 2: Specification for conformed stainless steel bars with 21-chromium, 10-nickel, 3-manganese and 2.5 molybdenum, strengthened by nitrogen (UNS S31675) 26/10/2010 070.01
ABNT NBR 15893-3:2010 Implants for orthopedics – Metallic materials – Part 3: Specification for conformed stainless steel bars and wires with low nickel, 23-manganese, 21-chromium and 1-molybdenum, strengthened by nitrogen (UNS S29108) 26/10/2010 070.01
ABNT NBR 15882:2010 Gas mixer for medicinal use – Autonomous oxygen and nitrous oxide mixer for medicinal use, its construction, installation and operation 25/10/2010 060.01
ABNT NBR IEC 60601-1:2010 (REVIEW) Electromedical equipment — Part 1: General prescriptions for basic safety and essential performance 25/10/2010 020.01
ABNT NBR IEC 60601-1-2:2010 (REVIEW) Electromedical equipment — Part 1-2: General prescriptions for basic safety and essential performance — Collateral Standard: Electromagnetic compatibility – Prescriptions and tests 25/10/2010 020.01
ABNT NBR IEC 60601-1-8:2010 Electromedical equipment — Part 1-8: General prescriptions for basic safety and essential performance — Collateral standard: General prescriptions, tests and guidelines for alarm systems on electromedical equipment and electromedical systems 25/10/2010 020.01
ABNT NBR 60601-1-10:2010 Electromedical equipment – Part 1-10: General prescriptions for basic safety and essential performance – Collateral standard: Prescriptions for the development of physiologic closed-loop controllers 25/10/2010 020.01
ABNT NBR 15743-2:2009 Amendment 1:2010 Implants for orthopedics — Guidance for selection of tests and information for proof of safety and effectiveness on product projects — Part 2: Coating of products 24/09/2010 070.01
ABNT NBR 15743-2:2010 Implants for orthopedics — Guidance for selection of tests and information for proof of safety and effectiveness on product projects — Part 2: Coating of products 24/09/2010 070.01
ABNT NBR 13730:2010 (REVIEW) Anesthesia device – Continuous flow section – Requirements of performance and safety 31/08/2010 060.01
ABNT NBR ISO 8835-2:2010 Inhalation anesthesia system – Part 2 – Anesthesia respiratory system 19/07/2010 060.01
ABNT NBR IEC 60601-1-9:2010 Electromedical equipment — Part 1-9: General prescriptions for basic safety and essential performance — Collateral standard: Prescriptions for an eco-responsible project 07/07/2010 020.01
ABNT NBR ISO 15223-1:2010 (REVIEW) Health products — Symbols to be used on labeling and information to be provided of health products — Part 1: General requirements 30/06/2010 150.01
ABNT NBR ISO 15664-9:2010 Implants for orthopedics — Coating of products — Part 9: Specifications for post of unalloyed titanium and alloy of titanium 6-aluminum 4-vanadium 26/06/2010 070.01
ABNT NBR 15804-1:2010 Materiais poliméricos para aplicações médicas – Parte 1: Especificações para resinas de policarbonato 19/02/2010 070.01


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2011