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Cleaning, Sterilization, and Biocompatibility
In December 2005, the International Electrotechnical Commission (IEC) released a new standard for medical devices, IEC 60601-1:2005, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance, Third Edition. This edition is a major redirection as it is much less prescriptive and now relies on risk management as the tool to assure that a medical device is safe. In fact, the standard requires manufacturers to use a risk management system that complies with ISO 14971:2000, Medical devices-Application of risk management to medical devices.
In the complex world of standards, the update process for a single standard is difficult enough to monitor, but now we have a new second edition of International Organization for Standardization (ISO) 14971 expected to be released by the end of 2006. Fortunately for this discussion, we find that ISO 14971 Second Edition will not be a major redesign as was IEC 60601-1 Third Edition. Note: The American National Standard versions of these documents are ANSI/AAMI/IEC ES60601-1:2005 and ANSI/AAMI/ISO 14971:2000, respectively.
For the medical device manufacturer, there are also a series of collateral and particular standards that may apply to their device. Each of these standards is a part of the 60601 family and as the parent, 60601-1, has been extensively revised, each of the collateral and particular standards also must be revised to mesh with the new parent. The manufacturer must also determine if other standards may apply to their product, such as those covering biocompatibility and sterilization.
For our discussion, we will concentrate on the relationship between 60601-1 and 14971, or how to use risk management to comply with the general safety standard. We will pick a specific set of examples to illustrate how to use these two standards together. We will also incorporate the use of the ANSI/AAMI/ISO 10993 biocompatibility standards and the sterilization family of standards in our examples as well.
60601-1 Requirements for Sterilization, Cleaning, and Disinfection
In clause 11.6.1, the general requirement for protection against hazards, the standard states that the manufacturer shall "...ensure a sufficient degree of protection against HAZARDS caused by...cleaning, disinfection, and sterilization as well as compatibility with substances used..."
Clause 11.6.6 allows manufacturers to define cleaning and disinfection procedures, but an analysis must be performed...