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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
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 07-07-2016
Publisher: Association for the Advancement of Medical Instrumentation
Glossary of equivalent standardsCommittee representationBackground of ANSI/AAMI adoption of ISO 16142-1:2016ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 Essential principles of safety and performance of medical devices5 Use of standards and guides in support of the essential principles6 Essential principles and references to relevant standards and guidesAnnex A (informative) - Rationale and guidanceAnnex B (normative) - Table relating essential principles to standardsAnnex C (informative) - Website listings of other standards suitable for the medical device sector and for assessment purposesAnnex D (informative) - Reference to the essential principles by International StandardsAnnex E (informative) - Terminology - alphabetized index of defined termsBibliography
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.
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