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Standards [CURRENT]

SNG CEN ISO/TR 20416

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)
Edition 2020-09

Regulation

EUV 2017/2185

Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council
Edition 2017-11-23

Clinical investigation of medical devices for human subjects - Good clinical practice.

Standards [CURRENT]

BS EN 1640

Dentistry - Medical devices for dentistry - Equipment
Edition 2009-11-30

Standards [CURRENT]

BS EN ISO 10993-7+A1

Biological evaluation of medical devices. Ethylene oxide sterilization residuals
Edition 2008-12-31

Standards [CURRENT]

BS EN 1642

Dentistry. Medical devices for dentistry. Dental implants
Edition 2011-10-31

Standards [CURRENT]

BS EN ISO 10993-11

Biological evaluation of medical devices. Tests for systemic toxicity
Edition 2018-06-18

Standards [CURRENT]

BS EN ISO 14155

Clinical investigation of medical devices for human subjects. Good clinical practice
Edition 2020-08-19

Biological evaluation of medical devices - Part 13: identification and quantification of degradation products from polymeric medical devices
Edition 2010-09-01

Medical devices - Information to be provided by the manufacturer
Edition 2021-05-05

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