Transcription of COMPLIANCE TO EN ISO 11607-1:2006/ AMD 1:2014
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COMPLIANCE TO EN ISO 11607-1:2006/ AMD 1:2014
Sterilisation Wrap COMPLIANCE TO. EN ISO 11607 -1:2006/. AMD 1:2014 . 1. The manufacturer, Halyard Health, does not accept any responsibility for the incorrect choice or misuse of the product shown in this brochure. All information contained in this brochure is as accurate as possible at the time of publication, however legislation and regulations are under constant review and may change in the lifetime of this brochure. Accordingly the specification for the product may be subject to change.. 2 3. TABLE OF CONTENTS HALYARD* STERILISATION WRAP. (NUMBERING FOLLOWS THE ORDER OF EN ISO 11607 -1:2006) LIST OF USED ACRONYMS AND ABBREVIATIONS. INTRODUCTION. 4. GENERAL REQUIREMENTS. Quality Systems Sampling Test Methods Documentation 5. MATERIALS AND PREFORMED STERILE BARRIER SYSTEMS C : Degree Celsius l: Liter General Requirements AAMI : Association for the Advancement of Medical Instrumentation lbs : Pounds AATCC : American Association of Textile Chemists and Colorists LPS : Laser Particle Counter Microbial Barrier Properties ANSI : American National Standards Institute m2 : Square meter Compatibility With The Sterilisation Process ASP : Advanced Sterilisation Products mbar : Millibar Compatibility With The Labelling System ASTM : American Society for Testing and Materials MD tear : Machine Direction Storage and Transport AVG BW : Average Basis Weight mg : Milligram BFE : Bacterial Filtration Efficiency ml.
6 7 HALYARD* STERILISATION WRAP COMPLIANCE TO EN ISO 11607-1:2006 INTRODUCTION Dear Customer, In July 2014, the technical committee ISO/TC 198 (Sterilisation of health care products)
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