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Standards [CURRENT]

OENORM EN ISO 81060-3

Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
Edition 2023-07-01

Standards [CURRENT]

OENORM EN ISO 28057

Clinical dosimetry - Dosimetry with solid thermoluminescence detectors for photon and electron radiations in radiotherapy (ISO 28057:2019)
Edition 2021-06-01

Standards [CURRENT]

OENORM EN ISO 8596

Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (ISO 8596:2017 + Amd1:2019) (consolidated version)
Edition 2020-06-01

Standards [CURRENT]

OENORM EN ISO 81060-2

Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018 + Amd 1:2020) (consolidated version)
Edition 2020-12-01

Regulation

EUV 2017/556

Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council
Edition 2017-03-24

Regulation

EUV 2020/1043

Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19)
Edition 2020-07-15

Standards [CURRENT]

SN EN ISO 8596

Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation (ISO 8596:2017)
Edition 2018-07

Standards [CURRENT]

SN EN ISO 11953

Dentistry - Implants - Clinical performance of hand torque instruments (ISO 11953:2010)
Edition 2010-09

Administrative provision

2005/28/EG

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
Edition 2005-04-08

Regulation [New]

EUV 2024/1381

Commission Implementing Regulation (EU) 2024/1381 of 23 May 2024 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medicinal products for human use at Union level, as well as templates for those joint clinical assessments
Edition 2024-05-23

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