BS EN ISO 11607-1 : 2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
Hardcopy , PDF
05-15-2018
English
01-01-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials and preformed sterile barrier systems
6 Design and development requirements for packaging
systems
7 Information to be provided
Annex A (informative) - Guidance on medical packaging
Annex B (informative) - Standardized test methods and
procedures that may be used to demonstrate
compliance with the requirements of this part
of ISO 11607
Annex C (normative) - Test method for resistance of
impermeable materials to the passage of air
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices
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.