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Standards [CURRENT]

BS EN ISO 15883-7

Washer-disinfectors. Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
Edition 2016-03-31

Standards [CURRENT]

BS EN ISO 15883-6

Washer-disinfectors. Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
Edition 2015-09-30

Standards [CURRENT]

BS EN ISO 11135+A1

Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2014-07-31

Standards [CURRENT]

OENORM EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Edition 2017-06-15

Medical devices - Quality management systems - Requirements for regulatory purposes
Edition 2016-04-30

Washer-disinfectors - Part 6: requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
Edition 2016-03-03

Washer-disinfectors - Part 7: requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
Edition 2016-07-01

Draft standard

OENORM EN ISO 11135

Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2024)
Edition 2024-02-01

Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
Edition 2004-02-01

Standards [CURRENT]

ISO 10993-5

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Edition 2009-06

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