NBR ISO 14971 : 2009
Withdrawn
Withdrawn
View Superseded by
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
Published date
01-12-2013
Publisher
Withdrawn date
07-17-2020
Superseded by
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| Committee |
CB-26
|
| DocumentType |
Standard
|
| PublisherName |
Brazilian Standards
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| ISO 14971:2007 | Identical |
| NBR IEC 60601-1-6 : 2011 ERRATA 1 2013 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY - COLLATERAL STANDARD: USABILITY |
| NBR 16379 : 2015 | IMPLANTS FOR BODY-COUNTOURING - SOFT-TISSUE EXPANDER DEVICES - SPECIFICATION FOR SILICONE ELASTOMER COMPONENTS |
| 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 ISO 10993-1 : 2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| NBR 15743-1 : 2017 | ORTHOPAEDIC IMPLANTS - TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS - PART 1: GENERAL PROVISIONS |
| NBR 16634 : 2017 | IMPLANTS FOR BODY-CONTOURING - TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS |
| NBR ISO 15223-1 : 2015 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| NBR IEC 60601-1-10 : 2010 AMD 1 2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS |
| 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 IEC 80601-2-35 : 2013 ERRATA 4 2018 | MEDICAL ELECTRICAL EQUIPMENT - PART 2:35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS OR MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE |
| NBR 16672-1 : 2017 | IMPLANTS FOR SURGERY - ABSORBABLE IMPLANTS DESIGN - PART 1: PROCESS REQUIREMENTS AND PRE-CLINICAL ASSESSMENT OF POLYMERIC IMPLANTS |
| NBR IEC 60601-1-2 : 2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| 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 16061 : 2016 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENT |
| NBR ISO 5367 : 2017 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS |
Summarise
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