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NBR ISO 14971 : 2009

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

Published date

12-01-2013

Withdrawn date

17-07-2020

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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Withdrawn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

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