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Standards [CURRENT]

SN EN 62366-1+AC

Medical devices - Part 1: Application of usability engineering to medical devices
Edition 2015-04

Standards [CURRENT]

SN EN 62366-1+AC+A1

Medical devices – Part 1: Application of usability engineering to medical devices
Edition 2020-08

Standards [CURRENT]

DIN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
Edition 2017-09

Standards [CURRENT]

SN EN 15986

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Edition 2011-07

Draft standard

DIN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024
Edition 2024-06

Technical rule [CURRENT]

VDI 5702 Blatt 1

Medical device software - Medical SPICE Process assessment model
Edition 2017-04

Technical rule [CURRENT]

VDI-MT 5702 Blatt 2

Medical device software - Medical SPICE - Qualification of developers and assessors
Edition 2023-03

Standards [CURRENT]

SN EN ISO 17664-2

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
Edition 2024-01

Standards [CURRENT]

SN EN 556-2

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Edition 2015-11

Standards [New]

SN EN 556-1

Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
Edition 2024-07

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