17/30351717 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials, preformed sterile barrier systems and
sterile barrier systems
6 Design and development for packaging systems
7 Usability evaluation for aseptic presentation
8 Packaging system performance and stability
9 Design changes and revalidation
10 Inspection of sterile medical devices packages
immediately prior to aseptic presentation
11 Information to be provided
Annex A (informative) - Guidance on medical
packaging
Annex B (informative) - Standardized test methods,
guides and procedures that may be used to demonstrate
compliance with the requirements of this part of ISO 11607
Annex C (normative) - Test method for defining impermeable
materials to the passage of air
Annex D (informative) - Environmental aspects
Annex E (informative) - Draft guidance on the relationship
between this standard and the general safety and
performance requirements of Regulation (EU) 2017/745
of the European Parliament and of the Council of
5 April 2017 on medical devices, amending Directive
2001/83/EC, Regulation (EC) No 178/2002 and
Regulation (EC) No 1223/2009 and repealing Council
Directives 90/385/EEC and 93/42/EEC
Annex F (informative) - Draft guidance on the relationship
between this standard and general safety and performance
requirements of Regulation (EU) 2017/746 of the European
Parliament and of the Council of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive
98/79/EC and Commission Decision 2010/227/EU
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
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.