CSA ISO 7199 : 0
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS)
Hardcopy , PDF
24-06-2005
English
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1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Tests and measurements to determine compliance
with this International Standard
6 Information supplied by the manufacturer
7 Packaging
Annex A (informative) Bibliography
Requirements for sterile, single-use, extracorporeal blood-gas exhangers (oxygenators) intended to supply oxygen to, and remove carbon dioxide from, human blood are defined in this standard. Also applicable to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.
| DevelopmentNote |
Supersedes CSA Z364.3. (08/2000)
|
| DocumentType |
Standard
|
| Pages |
19
|
| PublisherName |
Canadian Standards Association
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 7199:2016 | Identical |
| 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 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| ISO 8637:2010 | Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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 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 11137:1995 | Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
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