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Standards [CURRENT]

CAN/CSA-IEC 62304

Medical device software - Software life cycle processes (Adopted CEI/IEC 62304:2006, first edition, 2006-05)
Edition 2014-02-01

Standards [CURRENT]

CAN/CSA-IEC 62366-1

Medical devices - Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, first edition, 2015-02)
Edition 2015-11-01

Standards [CURRENT]

CAN/CSA-ISO/TS 17665-3

Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization (Adopted ISO/TS 17665-3:2013, first edition, 2013-04-15)
Edition 2017-12-01

Standards [CURRENT]

CAN/CSA-ISO 10079-1

Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2016, third edition, 2015-11-01)
Edition 2016-07-01

Standards [CURRENT]

CAN/CSA-ISO 10079-1A AMD 1

Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Changes to requirements for operating extremes of temperature
Edition 2019

Standards [CURRENT]

CAN/CSA-ISO 10079-2

Medical suction equipment - Part 2: Manually powered suction equipment (Adopted ISO 10079-2:2014, third edition, 2014-05-01)
Edition 2014-09-01

Standards [CURRENT]

CAN/CSA-ISO 10079-3

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01)
Edition 2014-09-01

Standards [CURRENT]

CAN/CSA-ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (Adopted ISO 13485:2016, third edition, 2016-03-01)
Edition 2016-09-01

Standards [CURRENT]

CAN/CSA-ISO 14937-11

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Edition 2011-10-01

Standards [CURRENT]

CAN/CSA-ISO 15883-6

Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (Adopted ISO 15883-6:2011, first edition, 2011-04-15)
Edition 2017-08-01

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