Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
Abstract
ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
DIN EN ISO 11607-2:2006-07 (E)
Packaging for terminally sterilized medical devices – Part 2: Validation requirements
for forming, sealing and assembly processes (ISO 11607-2:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….2
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..5
4 General requirements ……………………………………………………………………………………………………..8
4.1 Quality systems ………………………………………………………………………………………………………………8
4.2 Sampling ………………………………………………………………………………………………………………………..8
4.3 Test methods ………………………………………………………………………………………………………………….8
4.4 Documentation ……………………………………………………………………………………………………………….9
5 Validation of packaging processes ………………………………………………………………………………….9
5.1 General …………………………………………………………………………………………………………………………..9
5.2 Installation qualification (IQ) ………………………………………………………………………………………….10
5.3 Operational qualification (OQ) ……………………………………………………………………………………….10
5.4 Performance qualification (PQ) ……………………………………………………………………………………..11
5.5 Formal approval of the process validation ……………………………………………………………………..12
5.6 Process control and monitoring …………………………………………………………………………………….12
5.7 Process changes and revalidation …………………………………………………………………………………12
6 Packaging system assembly …………………………………………………………………………………………12
7 Use of reusable sterile barrier systems ………………………………………………………………………….13
8 Sterile fluid-path packaging …………………………………………………………………………………………..13
Annex A (informative) Process development …………………………………………………………………………………14
Bibliography …………………………………………………………………………………………………………………………………15
ANNEX ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices …………………………………………16