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CSA Z8638 : 2008

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
Available format(s)

Hardcopy , PDF

Superseded date

03-01-2012

Language(s)

English

Published date

01-01-2008

Publisher

Canadian Standards Association

1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 Biological safety
  4.2 Sterility
  4.3 Nonpyrogenicity
  4.4 Mechanical characteristics
  4.5 Expiration date
  4.6 Tubing compliance
5 Test methods
  5.1 General
  5.2 Biological safety
  5.3 Sterility
  5.4 Nonpyrogenicity
  5.5 Mechanical characteristics
  5.6 Expiration date
  5.7 Tubing compliance
6 Labelling
  6.1 Labelling on the device
  6.2 Labelling on the unit container
  6.3 Labelling on the outer container
  6.4 Accompanying documentation
Bibliography

Specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.

DevelopmentNote
Supersedes CSA Z364.1.2. (04/2008) Supersedes CSA Z364.1.1-Z364.1.2. (06/2008)
DocumentType
Standard
Pages
36
PublisherName
Canadian Standards Association
Status
Superseded
Supersedes

CSA Z8637 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS

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
CSA ISO 10993-11 : 0 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TEST FOR SYSTEMIC TOXICITY
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 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
CSA ISO 11134 : 0 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
CSA ISO 11135 : 1998:R2003 MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
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
CSA ISO 10993-7 : 1998 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
CSA ISO 10993-4 : 1997 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
CSA Z8637 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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