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AAMI RD17 : 2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
Available format(s)

Hardcopy , PDF

Superseded date

09-03-2010

Language(s)

English

Published date

01-01-2007

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 8638:2004
U.S. deviations to ISO 8638:2004
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
  4.1 Biological safety
  4.2 Sterility
  4.3 Nonpyrogenicity
  4.4 Mechanical characteristics
      4.4.1 Structural integrity
      4.4.2 Connection to hemodialyzer, hemodiafilter,
             or hemofilter
      4.4.3 Connection to vascular access device
      4.4.4 Connection to ancillary components
      4.4.5 Color coding
      4.4.6 Access ports
      4.4.7 Blood pathway volume
      4.4.8 Air-capture chamber fill level
      4.4.9 Transducer protectors
      4.4.10 Blood pathway flow dynamics
      4.4.11 Pump segment performance
  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
      5.5.1 Structural integrity test
      5.5.2 Connectors to hemodialyzer, hemodiafilter,
             or hemofilter
      5.5.3 Connector to vascular access device
      5.5.4 Connectors to ancillary components
      5.5.5 Color coding
      5.5.6 Access ports
      5.5.7 Blood pathway volume
      5.5.8 Air-capture chamber fill level
      5.5.9 Transducer protectors
      5.5.10 Blood pathway flow dynamics
      5.5.11 Pump segment performance
  5.6 Expiration date
  5.7 Tubing compliance
6 Labeling
  6.1 Labeling on the device
  6.2 Labeling on the unit container
  6.3 Labeling on the outer container
  6.4 Accompanying documentation
Annex A (informative) - Rationale for the development
                        and provisions of this standard
Bibliography

Describes the requirements for single-use extracorporeal blood circuit (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration, and hemofiltration.

Committee
RD
DocumentType
Standard
Pages
37
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

Standards Relationship
ISO 8638:2010 Identical

AAMI RD5 : 2003 HEMODIALYSIS SYSTEMS

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 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
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
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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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