Recognized standard
20857 First edition 2010-08-15 20857:2010/(R)2015
FDA recognition 14-340 · ISO · Sterility
Key facts
| Recognition number | 14-340 |
|---|---|
| Designation | 20857 First edition 2010-08-15 20857:2010/(R)2015 |
| Title | Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and… |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: