CAN/CSA-ISO 5833-00:2000 Edition

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Implants for Surgery – Acrylic Resin Cements

Published By	Publication Date	Number of Pages
CSA	2000-04-01	26

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, CSA

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Scope

This International Standard applies to radio-opaque and non- radio-opaque cements and specifies physical, mechanical, packaging and labelling requirements for self-curing resin cement based on poly(methacrylic acid esters), of two types intended respectively for use with a syringe or in the dough state for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation.

This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement.

All requirements apply to, and all the tests are to be performed on, the sterile product.

Published Code

CSA

Published By

Canadian Standards Association

Publication Date

2000-04-01

Pages Count

Language

English

Descriptors

Medical Equipment, Surgical Implants, Orthopaedic Implants, Bone Cements, Acrylic Resins, Specifications, Tests, Packaging, Marking Labelling