Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact).
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a) preparation before processing;
b) cleaning;
c) disinfection;
d) drying;
e) inspection and maintenance;
f) packaging;
g) storage;
h) transportation.
This document excludes processing of:
1) critical and semi-critical medical devices;
2) medical devices intended to be sterilized;
3) textile medical devices used in patient draping systems or surgical clothing;
4) medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device.
Please first log in with a verified email before subscribing to alerts.
Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click “alert me”.
Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click “alert me”.
ADD ALERT
Already Subscribed to this document.
Your Alert Profile lists the documents that will be monitored. If the document is revised or amended, you will be notified by email. You may delete a document from your Alert Profile at any time. To add a document to your Profile Alert, search for the document and click “alert me”.
PDF DOCUMENT FORMAT
Documents sold on the ANSI Webstore are in electronic Adobe Acrobat PDF format.
DRM PROTECTED DOCUMENTS
Some PDF files are protected by Digital Rights Management (DRM) at the request of the copyright holder. You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server. Some copyright holders may impose other restrictions that limit document printing and copy/paste of documents.
NON PRINTABLE DOCUMENTS
Those documents cannot be printed at the request of the copyright holder.
CONTENT PROVIDER International Organization for Standardization [iso]
We have no amendments or corrections for this standard.
Are the documents at the ANSI Webstore in electronic Adobe Acrobat PDF format only?
Documents sold on the ANSI Standards Store are in electronic Adobe Acrobat PDF format.
STANDARDS SUBSCRIPTIONS
This standard is also available to be included in Standards Subscriptions. Standards Subscriptions from ANSI provides a money-saving, multi-user solution for accessing standards.
Subscription pricing is determined by: the specific standard(s) or collections of standards, the number of locations accessing the standards, and the number of employees that need access.