AAMI ST81 : 2004 : R2010

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Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES

Publisher: Association for the Advancement of Medical Instrumentation

Published:

Available Formats: PDF - English - DRM, Hardcopy - English
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Glossary of equivalent standards Committee representation Foreword Introduction 1 Scope 2 Terms and definitions 3 Information to be provided by the   medical device manufacturer 4 Presentation of the information 5 Validation of the reprocessing   information provided 6 Risk analysis Annexes A - Commonly utilized reprocessing methods B - An example of reprocessing instructions     for reusable medical devices C - Bibliography D - Background of the development of     ANSI/AAMI ST81 and rationale for     national deviations to EN ISO 17664

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Describes the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the processor.

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Published
Document Type	Standard
Status	Superseded
Publisher	Association for the Advancement of Medical Instrumentation
ProductNote	Reconfirmed 2010
Pages
ISBN
Superseded By	AAMI ISO 17664 : 2017

Standards Referencing This Book - (Show below) - (Hide below)

ISO 11134 : 1994	STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
EN ISO 14937 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 15223 : 2000	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED
EN 285 : 2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
ISO 11135 : 2014	STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 7000 : 2014	GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - REGISTERED SYMBOLS
ISO 11607 : 2003	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

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