17/30338806 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Hardcopy , PDF
English
Foreword
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
12 Maintaining process effectiveness
Annex A (normative) - Process definition based on
inactivation of reference microorganisms And
knowledge of bioburden on product items to
be sterilized
Annex B (normative) - Process definition based on
inactivation of reference microorganisms
Annex C (informative) - Guidance on application of this
International Standard
Annex D (informative) - Environmental aspects regarding
development, validation and routine control of Low
Temperature Steam and Formaldehyde processes
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 90/385/EEC on active implantable
medical devices
Bibliography
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.