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ANSI/AAMI/ISO 16142-1:2016

Current
Current

The latest, up-to-date edition.

MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

07-07-2016

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 16142-1:2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential principles of safety and performance
  of medical devices
5 Use of standards and guides in support of the
  essential principles
6 Essential principles and references to relevant
  standards and guides
Annex A (informative) - Rationale and guidance
Annex B (normative) - Table relating essential principles
        to standards
Annex C (informative) - Website listings of other standards
        suitable for the medical device sector and for
        assessment purposes
Annex D (informative) - Reference to the essential principles
        by International Standards
Annex E (informative) - Terminology - alphabetized index
        of defined terms
Bibliography

Gives significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential principles that when met, indicate a medical device is safe and performs as intended.

DevelopmentNote
Supersedes AAMI ISO TIR 16142. (08/2017)
DocumentType
Standard
ISBN
1-57020-616-3
Pages
62
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

Standards Relationship
ISO 16142-1:2016 Identical

ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
ISO 5364:2016 Anaesthetic and respiratory equipment — Oropharyngeal airways
ISO 5360:2016 Anaesthetic vaporizers Agent-specific filling systems
ISO 7376:2009 Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
ISO 5367:2014 Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
ISO 5362:2006 Anaesthetic reservoir bags
ISO 6474-1:2010 Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina
ISO 3107:2011 Dentistry — Zinc oxide/eugenol cements and zinc oxide/non-eugenol cements
ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 7153-1:2016 Surgical instruments Materials Part 1: Metals
ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 7197:2006 Neurosurgical implants Sterile, single-use hydrocephalus shunts and components
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols

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