NBN EN ISO 11737-1 : 2006 COR 2009
Current
The latest, up-to-date edition.
STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement - Control of
nonconforming product
5 Selection of product
5.1 General
5.2 Sample item portion (SIP)
6 Methods of determination and microbial characterization
of bioburden
6.1 Determination of bioburden
6.2 Microbial characterization of bioburden
7 Validation of method for determining bioburden
8 Routine determination of bioburden and interpretation of
data
9 Maintenance of the method of determination of bioburden
9.1 Changes to the product and/or manufacturing process
9.2 Changes to the method of determination of bioburden
9.3 Revalidation of the method of determination of bioburden
Annex A (informative) Guidance on determination of a population
of microorganisms on product
Annex B (informative) Guidance on methods of determination of
bioburden
Annex C (informative) Validation of bioburden methods
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements
of EU Directives 90/385/EEC concerning
active implantable medical devices,
93/42/EEC concerning medical devices and
98/79/EC concerning in vitro diagnostic
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.