NBR 16634 : 2017
Superseded
Superseded
View Superseded by
IMPLANTS FOR BODY-CONTOURING - TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS
Published date
11-14-2017
Publisher
Superseded date
04-23-2022
Superseded by
Sorry this product is not available in your region.
| Committee |
CB-026
|
| DocumentType |
Standard
|
| PublisherName |
Brazilian Standards
|
| Status |
Superseded
|
| SupersededBy |
| NBR 16380 : 2015 | IMPLANTS FOR BODY-COUNTORING - FACIAL IMPLANTS - PARTICULAR REQUIREMENTS FOR SILICONE ELASTOMER COMPONENTS |
| NBR ISO 11607-1 : 2013 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIAL, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
| NBR 16288-1 : 2014 | IMPLANTS FOR ORTHOPEDICS - SILICONE ELASTOMERS - PART 1: SPECIFICATIONS AND GENERAL REQUIREMENTS |
| NBR 16379 : 2015 | IMPLANTS FOR BODY-COUNTOURING - SOFT-TISSUE EXPANDER DEVICES - SPECIFICATION FOR SILICONE ELASTOMER COMPONENTS |
| ISO 34-1:2015 | Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle and crescent test pieces |
| ISO/TR 14283:2004 | Implants for surgery — Fundamental principles |
| NBR ISO 14971 : 2009 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| NBR ISO 11607-2 : 2013 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
| NBR ISO 10993-1 : 2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| NBR ISO 14630 : 2013 ERRATA 1 2013 | NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| NBR 16341 : 2015 | BODY-CONTOURING IMPLANTS - REQUIREMENTS FOR BREAST IMPLANT |
Summarise
Sorry this product is not available in your region.