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BS EN ISO 11138-5 : 2017

M00020847

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BS EN ISO 11138-5 : 2017

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017)

British Standards Institution

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Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 General requirements<br>5 Test organism<br>6 Suspension<br>7 Carrier and primary packaging<br>8 Inoculated carriers and biological indicators<br>9 Population and resistance<br>Annex A (normative) - Method for determination of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;resistance to low-temperature steam and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;formaldehyde<br>Annex B (informative) - Rationale for the liquid-phase<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;test method for low-temperature steam and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;formaldehyde biological indicators<br>Bibliography

Abstract

Describes requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.

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Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/198
Supersedes
  • 04/30078111 DC : DRAFT JUL 2004
  • 15/30321514 DC : 0