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ISO 15675:2016

Current
Current

The latest, up-to-date edition.

Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

08-15-2016

ISO 15675:2016 specifies requirements for sterile, single-use, arterial blood line filters intended to filter and remove emboli, debris, blood clots and other potentially hazardous solid and gaseous material from the blood of humans during cardiopulmonary bypass surgery.

Committee
ISO/TC 150/SC 2
DevelopmentNote
Supersedes ISO/FDIS 15675. (08/2016) NEW CHILD AMD 1 2020 IS NOW ADDED.
DocumentType
Standard
Pages
9
ProductNote
NEW CHILD AMD 1 2020 IS NOW ADDED.
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Standards Relationship
BS ISO 15675:2009 Identical
ANSI/AAMI/ISO 15675:2016 Identical
NEN ISO 15675 : 2016 Identical

DIN EN ISO 7199:2015-06 (Draft) CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
ISO 11658:2012 Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems
ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
BS ISO 11658:2012 Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems
BS EN ISO 7199:2017 Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
15/30290736 DC : 0 BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
DIN EN ISO 7199 E : 2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
ANSI/AAMI/ISO 11658:2012 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS
EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
05/30134824 DC : 0 EN 50447 - ACTIVE IMPLANTABLE MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR HEART-LUNG MACHINES (HLM)
BS EN ISO 10993-4:2017 Biological evaluation of medical devices Selection of tests for interactions with blood
AAMI ISO 7199 : 2009 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
11/30227618 DC : 0 BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS
UNE-EN ISO 10993-4:2018 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
I.S. EN ISO 7199:2017 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016)
I.S. EN ISO 10993-4:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
EN ISO 7199:2017 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2016)

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 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
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 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
AAMI AT6 : 2013 AUTOLOGOUS TRANSFUSION DEVICES
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/TS 23810:2012 Cardiovascular implants and artificial organs Checklist for preoperative extracorporeal circulation equipment setup
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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

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