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Standards [CURRENT]

SN EN 868-3

Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
Edition 2017-04

Standards [CURRENT]

SN EN ISO 22610

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006)
Edition 2006-10

Standards [CURRENT]

SN EN ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
Edition 2008-03

Standards [CURRENT]

SN EN ISO 11137-1

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
Edition 2015-12

Standards [CURRENT]

SN EN ISO 11137-1/A2

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Revision to 4.3.4 and 1 (ISO 11137-1:2006/Amd 2:2018); Amendement A2
Edition 2020-04

Standards [CURRENT]

SN EN ISO 10993-15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
Edition 2023-05

Standards [CURRENT]

SN EN 928

In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
Edition 1996

Draft standard [New]

OENORM EN ISO 10993-17/A1

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAmd 1:2024)
Edition 2024-08-15

Pre-standard

OENORM ENV 13004

Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system
Edition 1999-10-01

Standards [CURRENT]

OENORM EN 15986

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Edition 2011-04-15

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