ANSI/AAMI/ISO 16142-1:2016
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
Hardcopy , PDF
English
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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