ISO 15674:2016
Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

Standard No.

ISO 15674:2016

Release Date

2016

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 15674:2016/Amd 1:2020

Latest

ISO 15674:2016/Amd 1:2020

ISO 15674:2016 Referenced Document

• ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
• ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
• ISO 14937:2009 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
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
• ISO 7199:2009 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
• ISO 8637:2010 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
• ISO/TS 23810:2012 Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup

ISO 15674:2016 history

• 2020 ISO 15674:2016/Amd 1:2020 Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — Amendment 1: Connectors
• 2016 ISO 15674:2016 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
• 2009 ISO 15674:2009 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
• 2001 ISO 15674:2001 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags