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API Technical Report TDB-6 Chapter 6 – Density

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ISO 5833:2002

ISO 5833:2002 Implants for surgery – Acrylic resin cements

CDN $233.00

SKU: b03a6c3ef5a5 Categories: ,

Description

This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, 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 tests are intended to be performed on, the sterile product.

Edition

2

Published Date

2002-06-06

Status

PUBLISHED

Pages

22

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, 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 tests are intended to be performed on, the sterile product.

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