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NBR 16380 : 2015

Withdrawn

Withdrawn

View Superseded by

IMPLANTS FOR BODY-COUNTORING - FACIAL IMPLANTS - PARTICULAR REQUIREMENTS FOR SILICONE ELASTOMER COMPONENTS

Published date

06-09-2015

Withdrawn date

02-20-2020

Superseded by

ABNT NBR 16380:2020

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Committee
CB-026
DocumentType
Standard
PublisherName
Brazilian Standards
Status
Withdrawn
SupersededBy

NBR 16634 : 2017 IMPLANTS FOR BODY-CONTOURING - TESTING SELECTION, INFORMATION AND REQUIREMENTS TO PROVIDE SAFETY AND EFFECTIVENESS

ISO 7619-1:2010 Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness)
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
ISO 34-1:2015 Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle and crescent test pieces
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
ISO 37:2017 Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
NBR ISO 14630 : 2013 ERRATA 1 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS

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