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CSA Z8637 : 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
Available format(s)

Hardcopy , PDF

Superseded date

01-03-2012

Language(s)

English

Published date

01-01-2008

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 Performance characteristics
  4.6 Expiration date
5 Test methods
  5.1 General
  5.2 Biological safety
  5.3 Sterility
  5.4 Nonpyrogenicity
  5.5 Mechanical characteristics
  5.6 Performance characteristics
  5.7 Expiration date
6 Labelling
  6.1 Labelling on the device
  6.2 Labelling on the unit containers
  6.3 Labelling on the outer containers
  6.4 Accompanying documentation
Bibliography

Specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use for humans.

DevelopmentNote
Supersedes CSA Z364.1.1. (04/2008) Supersedes CSA Z364.1.1-Z364.1.2. (06/2008)
DocumentType
Standard
Pages
42
PublisherName
Canadian Standards Association
Status
Superseded
Supersedes

CSA Z8638 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS

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
CSA C22.2 No. 60601.2.16 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
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
CSA Z364.2.2 : 2003 WATER TREATMENT EQUIPMENT AND WATER QUALITY REQUIREMENTS FOR HEMODIALYSIS
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
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 Z8638 : 2008 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
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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