I.S. EN ISO 11607-1:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014)
Hardcopy , PDF
23-01-2020
06-08-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
European foreword
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
Directive 93/42/EEC [OJ L 169] aimed to be
covered
Annex ZB (informative) - Relationship between this European
Standard and the essential requirements of
Directive 90/385/EEC [OJ L 189] aimed to be
covered
Annex ZC (informative) - Relationship between this European
Standard and the essential requirements of
Directive 98/79/EC [OJ L 331] aimed to be
covered
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