DIN EN ISO 7199:2014
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012); German version EN ISO 7199:2014

Standard No.

DIN EN ISO 7199:2014

Release Date

2014

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 7199:2017

DIN EN ISO 7199 E:2014-02

Latest

DIN EN ISO 7199:2023-08

Replace

DIN EN 12022:1999

DIN EN ISO 7199:2014 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 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• 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 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

DIN EN ISO 7199:2014 history

• 2023 DIN EN ISO 7199:2023-08 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO/DIS 7199:2023); German and English version prEN ISO 7199:2023 / Note: Date of issue 2023-06-30*Intended as replacement for DIN EN ISO 7199 (2020-10).
• 2020 DIN EN ISO 7199:2020-10 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016 + Amd 1:2020); German version EN ISO 7199:2017 + A1:2020
• 2020 DIN EN ISO 7199:2020 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016 + Amd 1:2020) (includes Amendment :2020)
• 1970 DIN EN ISO 7199 A1 E:2018-09
• 2017 DIN EN ISO 7199:2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016); German version EN ISO 7199:2017
• 2014 DIN EN ISO 7199:2014 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012); German version EN ISO 7199:2014
• 1999 DIN EN 12022:1999 Blood gas exchangers; German version EN 12022:1999
• 0000 DIN EN 12022:1995

DIN EN ISO 7199:2014 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012); German version EN ISO 7199:2014 has been changed from DIN EN 12022:1999 Blood gas exchangers; German version EN 12022:1999.