17/30351720 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
Hardcopy , PDF
English
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Validation of packaging processing
6 Packaging system assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
Annex A (informative) - Process development
Annex B (informative) - Draft guidance on the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Annex C (informative) - Draft guidance on the relationship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
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