BS EN ISO 8638:2014
Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

Standard No.

BS EN ISO 8638:2014

Release Date

2014

Published By

British Standards Institution (BSI)

Status

Be replaced 2018-10

Replace By

BS EN ISO 8637-2:2018

Latest

BS EN ISO 8637-2:2018

Replace

BS EN 1283:1996

BS EN ISO 8638:2014 Referenced Document

• 93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood*， 2017-04-01 Update
• ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
• ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4*， 2018-11-08 Update
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
• ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*， 2017-06-01 Update
• ISO 14937 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 15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1
• ISO 15223-2 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
• ISO 17665-1 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 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
• ISO 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update
• ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods*， 2016-08-01 Update
• ISO 8637 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators - Amendment 1: Revision to Figure 2 - Main fitting dimensions of dialysis fluid inlet and outlet ports
• ISO/TS 11135-2 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1; Technical Corrigendum 1

BS EN ISO 8638:2014 history

• 2014 BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
• 1996 BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits

BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters was changed to BS EN ISO 8637-2:2018 Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters.