This document references:
21 CFR PART 801 - LABELING
Published by HHS
on
April 1, 2014
A description is not available for this item.
This document references:
21 CFR PART 812 - INVESTIGATIONAL DEVICE EXEMPTIONS
Published by HHS
on
April 1, 2018
(a) The purpose of this part is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices...
This document references:
21 CFR PART 820 - QUALITY SYSTEM REGULATION
Published by FAA
on
April 1, 2020
(a) Applicability. (1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the...
This document references:
21 CFR PART 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES
Published by HHS
on
April 1, 2018
(a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation...
This document references:
AAMI ST8 - Hospital steam sterilizers
Published by AAMI
on
January 1, 2013
General This standard applies to steam sterilizers that are intended for use in hospitals and other health care facilities and that have a volume greater than 56.63 liters (L) (2 cubic feet [ft3])....
This document references:
AAMI ST8 - Hospital steam sterilizers
Published by AAMI
on
January 1, 2013
General This standard applies to steam sterilizers that are intended for use in hospitals and other health care facilities and that have a volume greater than 56.63 liters (L) (2 cubic feet [ft3])....
This document is referenced by:
CSA Z8000 - Canadian health care facilities
Published by CSA
on
July 1, 2018
General This Standard describes essential elements and specific requirements for the planning, design, and construction of HCFs. It applies to all facilities, public or private, that provide health...