NBR ISO 10993-1 : 2013
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
Published date
12-01-2013
Publisher
Superseded date
14-05-2022
Superseded by
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| Committee |
CB-26
|
| DocumentType |
Standard
|
| PublisherName |
Brazilian Standards
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 10993-1:2009 | Identical |
| NBR 15743-7 : 2017 | ORTHOPAEDIC IMPLANTS - TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS - PART 7: IMPLANTS MANUFACTURED OF ABSORBABLE POLYMERS |
| NBR 16379 : 2015 | IMPLANTS FOR BODY-COUNTOURING - SOFT-TISSUE EXPANDER DEVICES - SPECIFICATION FOR SILICONE ELASTOMER COMPONENTS |
| NBR 16288-1 : 2014 | IMPLANTS FOR ORTHOPEDICS - SILICONE ELASTOMERS - PART 1: SPECIFICATIONS AND GENERAL REQUIREMENTS |
| NBR 15804-3 : 2013 | POLYMERIC MATERIALS FOR MEDICAL APPLICATIONS - PART 3: GUIDE FOR ASSESSMENT OF THERMOPLASTIC POLYURETHANE SOLIDS AND SOLUTIONS |
| NBR 15804-2 : 2013 | POLYMERIC MATERIALS FOR MEDICAL APPLICATIONS - PART 2: SPECIFICATION FOR POLYETHYLENE PLASTICS FOR SHORT-TERM IMPLANTABLE DEVICES |
| NBR ISO 10993-15 : 2005 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
| NBR 15723-3 : 2010 | IMPLANTS FOR SURGERY - POLYMERIC MATERIALS - PART 3: SPECIFICATION FOR POLYARYLETHERKETONE (PAEK) POLYMERS |
| NBR ISO 25841 : 2015 | FEMALE CONDOMS - REQUIREMENTS AND TEST METHODS |
| NBR ISO 5361 : 2017 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS |
| NBR 15720-3 : 2018 | IMPLANTS FOR SURGERY - CERAMIC MATERIALS - PART 3: REQUIREMENTS FOR HEMI-DYDRATE IR DEHYDRATE CALCIUM SULFATE WITH HIGH PURITY |
| NBR 15723-9 : 2010 | IMPLANTS FOR SURGERY - POLYMERIC MATERIALS - PART 9: CRITERIA FOR DEFINITION AND DESCRIPTION OF THERMOSET EPOXY PLASTICS |
| NBR 15743-1 : 2017 | ORTHOPAEDIC IMPLANTS - TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS - PART 1: GENERAL PROVISIONS |
| NBR 15774 : NOV 2014 | IMPLANTS AND MEDICAL DEVICES FOR ORTHOPAEDIC SURGERY - GUIDANCE FOR BIOCOMPATIBILITY EVALUATION OF STERILE BARRIER SYSTEM INTENTED TO DEVICE PACKAGING |
| NBR 16634 : 2017 | IMPLANTS FOR BODY-CONTOURING - TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS |
| NBR 15723-6 : 2010 | IMPLANTS FOR SURGERY - POLYMERIC MATERIALS - PART 6: SPECIFICATION FOR POLYTETRA FLUOROETHYLENE (PTFE) POLYMERS IN SHEET, TUBE, AND ROD SHAPES |
| NBR 15804-1 : JUN 2010 | POLYMERIC MATERIALS FOR MEDICAL APPLICATIONS - PART 1: SPECIFICATION FOR POLYCARBONATE RESIN |
| NBR 15743-4 : 2017 | ORTHOPAEDIC IMPLANTS -TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS - PART 4: TOTAL INTERVERTEBRAL DISC PROSTHESIS |
| NBR 16664-1 : 2017 | NEUROSURGICAL IMPLANTS - HYDROCEPHALUS SHUNT - PART 1: GENERAL PROVISIONS |
| NBR 15743-3 : 2017 | ORTHOPAEDIC IMPLANTS -TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS - PART 3: DEVICES FOR ARTHRODESIS OF VERTEBRAL BODIES |
| NBR ISO 10993-7 : 2005 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
| NBR 16627-5 : 2018 | IMPLANTS FOR SURGERY - DESIGN OF IMPLANTS OBTAINED BY ADDITIVE MANUFACTURING - PART 5: GUIDANCE, INFORMATION AND REQUIREMENTS FOR PROVIDING SAFETY AND EFFECTIVENESS OF PRODUCTS MANUFACTURED BY THREE-DIMENSIONAL PRINTING |
| NBR 15723-12 : 2013 | IMPLANTS FOR SURGERY - POLYMERIC MATERIALS - PART 12: SPECIFICATION FOR ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE YARNS |
| NBR 15723-7 : 2013 | IMPLANTS FOR SURGERY - POLYMERIC MATERIALS - PART 7: SPECIFICATION FOR POLYETHERKETONEETHER-KETONEKETONE (PEKEKK) POLYMERS |
| NBR 16610 : 2017 | ORTHOPAEDIC IMPLANTS DESIGN - IDENTIFICATION AND CHARACTERIZATION OF ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE |
| NBR ISO 7376 : 2016 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION |
| NBR ISO 7439 : 2014 | COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS |
| NBR 16672-1 : 2017 | IMPLANTS FOR SURGERY - ABSORBABLE IMPLANTS DESIGN - PART 1: PROCESS REQUIREMENTS AND PRE-CLINICAL ASSESSMENT OF POLYMERIC IMPLANTS |
| NBR ISO 14630 : 2013 ERRATA 1 2013 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| NBR 16380 : 2015 | IMPLANTS FOR BODY-COUNTORING - FACIAL IMPLANTS - PARTICULAR REQUIREMENTS FOR SILICONE ELASTOMER COMPONENTS |
| NBR ISO 8836 : 2017 | SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT |
| NBR ISO 5367 : 2017 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
| NBR 16341 : 2015 | BODY-CONTOURING IMPLANTS - REQUIREMENTS FOR BREAST IMPLANT |
| NBR ISO 10993-15 : 2005 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-18:2005 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials |
| ISO 10993-10:2010 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| NBR ISO 10993-12 : 2016 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| NBR ISO 14971 : 2009 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
| ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
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