SS-EN-ISO-7199 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)

SS-EN-ISO-7199 - 2014 EDITION - CURRENT


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This standard specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. This standard also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device. This standard does not apply to: ? implanted oxygenators; ? liquid oxygenators; ? extracorporeal circuits (blood tubing); ? separate heat exchangers; ? separate ancillary devices.

To find similar documents by classification:

11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)


Revised Machinery Directive

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Designation Name

SS-EN ISO 7199:2014

Revision Level

2014 EDITION

Status

Current

Publication Date

Aug. 11, 2014

Language(s)

English

Page Count

28

International Equivalent

EN ISO 7199:2014(IDT); ISO 7199:2009(IDT)