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Guidline

Standards [CURRENT]

BS EN ISO 10993-13

Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices
Edition 2010-10-31

Regulation

EUV 2017/745Ber

Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Edition 2019-05-03

Regulation

EUV 2017/745Ber 2019

Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Edition 2019-12-27

Regulation

EUV 2017/745Ber 2021

Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Edition 2021-07-08

Standards [CURRENT]

BS EN 556-2

Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
Edition 2015-09-30

Regulation

BfArMAMDV

Verordnung über das datenbankgestützte Informationssystem über Arzneimittel des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM-Arzneimitteldatenverordnung)
Edition 2010-02-24

Draft standard

PR NF S98-107-2 ; PR NF EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: requirements for aseptically processed medical devices

Draft standard

PR NF S98-107-1 ; PR NF EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

Standards [CURRENT]

NF S98-104 ; NF EN ISO 20857:2013-07-19

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2013-07-19

Standards [CURRENT]

NF S99-015 ; NF EN 15986:2011-04-01

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Edition 2011-04-01

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