ISO 8637:2010
Withdrawn
Withdrawn
View Superseded by
Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
Amended by
Available format(s)
Hardcopy , PDF
Published date
06-28-2010
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
ISO 8637:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
| Committee |
ISO/TC 150/SC 2
|
| DevelopmentNote |
Supersedes ISO/DIS 8637. (06/2010)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| AAMI ISO 8637 : 2010 | Identical |
| NF EN ISO 8637 : 2014 | Identical |
| NBN EN ISO 8637 : 2014 | Identical |
| NEN EN ISO 8637 : 2014 | Identical |
| NS EN ISO 8637 : 2014 | Identical |
| I.S. EN ISO 8637:2014 | Identical |
| PN EN ISO 8637 : 2014 | Identical |
| BIS IS/ISO 8637 : 2012 | Identical |
| BS EN ISO 8637:2014 | Identical |
| EN ISO 8637:2014 | Identical |
| DIN EN ISO 8637:2014-03 | Identical |
| NEN-EN-ISO 8637-1:2020 en | Identical |
| GOST R ISO 8637 : 1999 | Identical |
| NEN ISO 8637 : 2010 AMD 1 2013 | Identical |
| UNE-EN ISO 8637:2014 | Identical |
| AAMI RD16 : 2007 | Identical |
| BS 7297-1:1990 | Identical |
| AAMI RD17 : 2007 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
| DIN EN ISO 8638:2014-03 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
| BS EN ISO 8638:2014 | Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| DIN EN ISO 7199:2015-06 (Draft) | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) (ISO 7199:2016) |
| ANSI/AAMI/ISO 15674:2016 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
| ISO 15675:2016 | Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 8638:2010 | Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| EN ISO 8638:2014 | Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010) |
| ISO 13960:2010 | Cardiovascular implants and extracorporeal systems — Plasmafilters |
| ANSI/AAMI/ISO 15675:2016 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
| 08/30179586 DC : DRAFT MAR 2008 | BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| BS EN ISO 7199:2017 | Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) |
| 15/30321712 DC : 0 | BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
| 15/30321957 DC : 0 | BS EN ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| BS ISO 18241:2016 | Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps |
| BS ISO 15674:2009 | Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
| 15/30290736 DC : 0 | BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
| AAMI ISO 8638 : 2010 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
| AAMI ISO 8638 : 2010 : R2015 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
| ISO 7199:2016 | Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 18241:2016 | Cardiovascular implants and extracorporeal systems — Cardiopulmonary bypass systems — Venous bubble traps |
| ANSI/AAMI/ISO 18241:2016 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| I.S. EN ISO 8638:2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
| EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| 01/561789 DC : DRAFT APR 2001 | BS ISO 13960 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - PLASMAFILTERS |
| BS EN ISO 10993-4:2017 | Biological evaluation of medical devices Selection of tests for interactions with blood |
| 02/565260 DC : DRAFT DEC 2002 | ISO 8638 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
| ISO 15674:2016 | Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags |
| BS 7297-2:1990 | Haemodialysers and related equipment Specification for extracorporeal circuits for use with haemodialysers, haemofilters and haemoconcentrators |
| 13/30255554 DC : 0 | BS EN ISO 80369-7 - SMALL BORE CONNECTORS FOR LIQUIDS AND GASES IN HEALTHCARE APPLICATIONS - PART 7: CONNECTORS WITH 6% (LUER) TAPER FOR INTRAVASCULAR OR HYPODERMIC APPLICATIONS |
| AAMI ISO 7199 : 2009 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| 08/30179589 DC : DRAFT MAR 2008 | BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
| AAMI RD5 : 2003 | HEMODIALYSIS SYSTEMS |
| BS ISO 7199 : 2009 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
| 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) |
| UNE-EN ISO 10993-4:2018 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| 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 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/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| ISO 8638:2010 | Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
| 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 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 11137-3:2017 | Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO/TS 11135-2:2008 | Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| 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 |
Summarise
US$96.00
Excluding Tax where applicable
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