国际标准

EN ISO 20857-2013 欧盟标准

作者：未知发布时间2025-04-14

Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization/depyrogenation
12 Maintaining process effectiveness
Annex A (informative) - Guidance on the application of
this International Standard
Annex B (informative) - Process definition based on
inactivation of the microbial population in its
natural state (bioburden-based approach)
Annex C (informative) - Process definition based on the
inactivation of reference microorganisms and
knowledge of bioburden (combined bioburden/biological
indicator approach)
Annex D (informative) - Conservative process definition
based on inactivation of reference microorganisms
(overkill method)
Annex E (informative) - Process development
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable Medical
Devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZC (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 98/79/EC on in vitro diagnostic medical
devices

标准简介：Defines requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.