NBR ISO 14630 : 2013 ERRATA 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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
Published date
12-01-2013
Publisher
Superseded date
13-01-2026
Superseded by
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| Committee |
CB-026
|
| DocumentType |
Standard
|
| PublisherName |
Brazilian Standards
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| ISO 14630:2012 | Identical |
| NBR 16379 : 2015 | IMPLANTS FOR BODY-COUNTOURING - SOFT-TISSUE EXPANDER DEVICES - SPECIFICATION FOR SILICONE ELASTOMER COMPONENTS |
| NBR 16499-1 : 2016 | NON-ACTIVE SURGICAL IMPLANTS - EFFECTS IN MAGNETIC RESONANCE IMAGING ENVIRONMENT - PART 1: TEST METHOD FOR CHARACTERIZATION OF IMAGE ARTIFACTS |
| NBR 16664-1 : 2017 | NEUROSURGICAL IMPLANTS - HYDROCEPHALUS SHUNT - PART 1: GENERAL PROVISIONS |
| NBR 16499-3 : 2016 | NON-ACTIVE SURGICAL IMPLANTS - EFFECTS IN MAGNETIC RESONANCE IMAGING ENVIRONMENT - PART 3: TEST METHOD FOR DISPLACEMENT FORCE MAGNETICALLY INDUCED ASSESSMENT |
| NBR ISO 7439 : 2014 | COPPER-BEARING CONTRACEPTIVE INTRAUTERINE DEVICES - REQUIREMENTS AND TESTS |
| NBR 15719 : 2016 | IMPLANTS FOR ORTHOPEDICS - HIP JOINT PROSTHESES - SPECIFICATION FOR ACETABULAR PROSTHESES |
| NBR 15727 : 2018 | IMPLANTS FOR ORTHOPAEDICS - REQUIREMENTS FOR METALLIC STRANDS AND CABLES |
| NBR ISO 21536 : 2014 | NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS |
| NBR 15743-1 : 2017 | ORTHOPAEDIC IMPLANTS - TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS - PART 1: GENERAL PROVISIONS |
| NBR 16499-2 : 2016 | NON-ACTIVE SURGICAL IMPLANTS - EFFECTS IN MAGNETIC RESONANCE IMAGING ENVIRONMENT - PART 2: TEST METHOD FOR MAGNETICALLY INDUCED TORQUE ASSESSMENT |
| NBR 16634 : 2017 | IMPLANTS FOR BODY-CONTOURING - TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS |
| NBR ISO 9713 : 2017 | NEUROSURGICAL IMPLANTS - SELF-CLOSING INTRACRANIAL ANEURYSM CLIPS |
| 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 16610 : 2017 | ORTHOPAEDIC IMPLANTS DESIGN - IDENTIFICATION AND CHARACTERIZATION OF ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE |
| NBR 12932 : 2017 | IMPLANTS FOR SURGERY - MARKING AND PREPARATION OF UNCOATED SURFACE OF METALLIC COMPONENTS - REQUIREMENTS AND METHODS |
| NBR 16672-1 : 2017 | IMPLANTS FOR SURGERY - ABSORBABLE IMPLANTS DESIGN - PART 1: PROCESS REQUIREMENTS AND PRE-CLINICAL ASSESSMENT OF POLYMERIC IMPLANTS |
| NBR 16380 : 2015 | IMPLANTS FOR BODY-COUNTORING - FACIAL IMPLANTS - PARTICULAR REQUIREMENTS FOR SILICONE ELASTOMER COMPONENTS |
| NBR 15165 : 2017 | IMPLANTS FOR SURGERY - REQUIREMENTS FOR MARKING, PACKAGING AND LABELLING |
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 80000-4:2006 | Quantities and units — Part 4: Mechanics |
| IEC 80000-6:2008 | Quantities and units - Part 6: Electromagnetism |
| ISO 14160:2011 | Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| ISO 80000-9:2009 | Quantities and units — Part 9: Physical chemistry and molecular physics |
| ISO 14937:2009 | Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| ISO 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 80000-3:2006 | Quantities and units — Part 3: Space and time |
| ISO 80000-8:2007 | Quantities and units — Part 8: Acoustics |
| ISO 80000-2:2009 | Quantities and units — Part 2: Mathematical signs and symbols to be used in the natural sciences and technology |
| ISO 8601:2004 | Data elements and interchange formats — Information interchange — Representation of dates and times |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| 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 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 80000-11:2008 | Quantities and units — Part 11: Characteristic numbers |
| IEC 80000-14:2008 | Quantities and units - Part 14: Telebiometrics related to human physiology |
| ISO 80000-12:2009 | Quantities and units — Part 12: Solid state physics |
| IEC 80000-13:2008 | Quantities and units - Part 13: Information science and technology |
| ISO 80000-1:2009 | Quantities and units — Part 1: General |
| NBR ISO 10993-1 : 2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 80000-7:2008 | Quantities and units — Part 7: Light |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 17664:2017 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 80000-5:2007 | Quantities and units — Part 5: Thermodynamics |
| ISO 80000-10:2009 | Quantities and units — Part 10: Atomic and nuclear physics |
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