Standard: AAMI SPVVQ

BASIC CONCEPTS IN STERILIZATION PROCESSES VERIFICATION, VALIDATION, AND QUALIFICATION

This standard is available for individual purchase.

or unlock this standard with a subscription to IHS Standards Expert

IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).

FEATURES & BENEFITS
  • Maximize product development and R&D with direct access to over 1.6 million standards
  • Discover new markets: Identify unmet needs and discover next-generation technologies
  • Improve quality by leveraging consistent standards to meet customer and market requirements
  • Minimize risk: Mitigate liability and better understand compliance regulations
  • Boost efficiency: Speed up research, capture and reuse expertise
For additional product information, visit the IHS Standards Expert page.

HOW TO SUBSCRIBE
For more information or a custom quote, visit the IHS Contact Us page for regional contact information.
Scope:

Introduction

Healthcare sterile processing and medical device manufacturing professionals of today need a comprehensive understanding of sterilization processes and how to produce sterile product. Device manufacturers are required to provide information to the Food and Drug Administration (FDA) on how they will address the manufacturing of all products and how reusable products are to be cleaned and sterilized by the end user or sterile processing professional. For device manufacturers to fulfill this obligation, an understanding of the cleaning and sterilization processes used in health care is required. Sterile processing professionals must ensure that

a) their sterilization processes meet quality assurance standards;

b) they are adhering to these processes;

c) the methods used for the products that they process are verified; and

d) the processes used for the sterile products they create are validated.

This book is intended to be used as a textbook by medical device manufacturers, healthcare sterile processing professionals, and students of sterilization. It explains concepts and provides examples and definitions for sterilization science, quality management, validation theory, and cleaning and sterilization practices, focusing on steam sterilization as a model process for hospital application and on product quality assurance testing methods used in U.S. hospitals.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami spvvq
Publish Date: 2014-01-01
Page Count: 132
Change Type: NEW ADDITION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active
Advertisement
Advertisement
Advertisement
Advertisement