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NBR ISO 16061 : 2016

Withdrawn

Withdrawn

View Superseded by

INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENT

Published date

01-12-2013

Withdrawn date

04-13-2021

Superseded by

ABNT NBR ISO 16061:2021

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Withdrawn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

Standards Relationship
ISO 16061:2015 Identical

NBR ISO 9713 : 2017 NEUROSURGICAL IMPLANTS - SELF-CLOSING INTRACRANIAL ANEURYSM CLIPS

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
NBR ISO 11607-1 : 2013 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIAL, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 8601:2004 Data elements and interchange formats — Information interchange — Representation of dates and times
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
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
ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good clinical practice

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