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STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Canadian Standards Association
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Availability date: 10/28/2021
Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Quality management system elements<br>5 Sterilizing agent characterization<br>6 Process and equipment characterization<br>7 Product definition<br>8 Process definition<br>9 Validation<br>10 Routine monitoring and control<br>11 Product release from sterilization<br>12 Maintaining process effectiveness<br>Annex A (informative) - Guidance<br>Annex B (informative) - Process definition based on <br> inactivation of the microbial population in its <br> natural state (bioburden-based method)<br>Annex C (informative) - Process definition based on the <br> inactivation of a reference microorganism and a <br> knowledge of bioburden on product items to be <br> sterilized (combined bioburden/biological <br> indicator based method)<br>Annex D (informative) - Conservative process definition <br> based on inactivation of reference microorganisms <br> (overkill method)<br>Annex E (informative) - Operating cycles<br>Bibliography
Describes requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Published | |
Document Type | Standard |
Status | Current |
Publisher | Canadian Standards Association |
ProductNote | Reconfirmed EN |
Pages | |
ISBN |