NEN EN ISO 11137-1 : 2015
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
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 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 Process
6.2 Equipment
7 Product definition
8 Process definition
8.1 Establishing the maximum acceptable dose
8.2 Establishing the sterilization dose
8.3 Specifying the maximum acceptable dose and the
sterilization dose
8.4 Transference of maximum acceptable, verification
or sterilization dose between radiation sources
9 Validation
9.1 Installation qualification
9.2 Operational qualification
9.3 Performance qualification
9.4 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
12.1 Demonstration of continued effectiveness
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification of equipment
12.5 Assessment of change
Annex A (informative) Guidance
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/EEC concerning in vitro diagnostic
medical devices
Bibliography
Defines requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
DevelopmentNote |
Supersedes NEN EN 552. (05/2006) NEW CHILD AMD 2 IS NOW ADDED
|
DocumentType |
Standard
|
ProductNote |
NEW CHILD AMD 2 IS NOW ADDED
|
PublisherName |
Netherlands Standards
|
Status |
Current
|
Standards | Relationship |
ISO 11137-1:2006 | Identical |
UNI EN ISO 11137-1 : 2013 | Identical |
NF EN ISO 11137-1 : 2016 | Identical |
DIN EN ISO 11137-1:2015-11 | Identical |
I.S. EN ISO 11137-1:2015 | Identical |
UNE-EN ISO 11137-1:2015 | Identical |
EN ISO 11137-1:2015 | Identical |
SN EN ISO 11137-1 : 2015 | Identical |
BS EN ISO 11137-1:2015 | Identical |
NS EN ISO 11137-1 : 2015 | Identical |
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.