Source: https://shop.standards.ie/en-ie/Standards/BS-ISO-16142-2-2017-293227_SAIG_BSI_BSI_680127/
Timestamp: 2020-07-02 06:08:58
Document Index: 800411337

Matched Legal Cases: ['ART 2', 'ART 2', 'ART 1', 'ART 2', 'ART 2', 'ART 2']

BS ISO 16142-2 : 2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL S | NSAI
BS ISO 16142-2 : 2017
4 Essential principles of safety and performance of
5 Use of standards and guides in support of the essential
6 Essential principles and references to relevant standards
Annex B (normative) - Table relating essential principles
Annex C (informative) - Website listings of other standards
suitable for the medical device sector and for assessment
Annex D (informative) - Reference to the essential principles
Annex E (informative) - Terminology - Alphabetized index
of defined terms
Specifies the six general essential principles of safety and performance that apply to all medical devices, including IVD medical devices (in vitro diagnostic).
Committee CH/210
15/30328959 DC : 0
16/30346073 DC : 0
ISO 16142-2 : 2017 Identical
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ISO TR 24971 : 2013 MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 14971
ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
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