ISO 8637-1:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
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English, French
28-11-2017
31-05-2024
ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply to:
- extracorporeal blood circuits;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
- reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.
| Committee |
ISO/TC 150/SC 2
|
| DevelopmentNote |
Supersedes ISO/DIS 8637-1 and ISO 8637. (11/2017)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes | |
| UnderRevision |
| Standards | Relationship |
| NF EN ISO 8637-1:2020 | Identical |
| DIN EN ISO 8637-1:2020-10 | Identical |
| EN ISO 8637-1:2020 | Identical |
| I.S. EN ISO 8637-1:2020 | Identical |
| BS EN ISO 8637-1:2020 | Identical |
| NS-EN ISO 8637-1:2020 | Identical |
| ÖNORM EN ISO 8637-1:2020 10 01 | Identical |
| IS/ISO 8637 : Part 1 : 2017 | Identical |
| ANSI/AAMI/ISO 8637-1:2017 | Identical |
| UNE-EN ISO 8637-1:2020 | Identical |
| CEI EN IEC 60601-2-16:2019 | Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| 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 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/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| 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 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 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications |
| ISO 7000:2014 | Graphical symbols for use on equipment — Registered symbols |
| 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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