Glossary of equivalent standards
lowing annexes (J and K) after Annex I.
Committee representation
Acknowledgments
Foreword
1 Scope
2 Applicability and use
3 Normative references
4 Definitions
5 General requirements
5.1 Quality systems
5.2 Test methods
5.3 Sampling
6 Design inputs
7 Selection and evaluation of materials
7.1 Sterilization requirements (ANSI/AAMI/ISO11607-1:
2006, 5.1.6(e) and 5.3))
7.2 Safety requirements (ANSI/AAMI/ISO 11607-1:2006,
5.1.5 and 5.1.6)
7.3 Barrier requirements. (ANSI/AAMI/ISO 11607-1:2006,
5.1.4 and 5.1.6)
7.4 Visibility and appearance requirements
7.5 Durability requirements (ANSI/AAMI/ISO 11607-1:
2006, 5.1.6(c), 5.1.7(e), and 6.3.2)
7.6 Heat sealability requirements (ANSI/AAMI/ISO
11607-1:2006, 5.1.6d and 5.1.8(c) )
7.7 Processing requirements (ANSI/AAMI/ISO 11607-1:
2006, 5.1.2 - 5.1.9)
7.8 Printing requirements (ANSI/AAMI/ISO 11607-1:2006,
5.4)
7.9 Cleanliness and particulate requirements (ANSI/AAMI/ISO
11607-1:2006, 5.1.7(d) )
7.10 Device-packaging system interaction
7.11 Self seal peelable preformed sterile barrier system
requirements
8 Sterile barrier system and protective packaging design
(packaging System development)
8.1 Key elements in the design
8.2 Steps in packaging system design
9 Packaging process feasibility evaluation
9.1 Feasibility evaluation for initial and full-scale
packaging process
9.2 Sterile barrier system process
9.3 Equipment IQ Requirement
9.4 Process parameters
9.5 Prototype or trial runs
10 Sterile barrier system design feasibility evaluation
10.1 Sterile barrier system design feasibility evaluation
performance
10.2 Sterile barrier system test method
10.3 Worst case feasibility condition
10.4 Pass/fail status of packaging system
11 Validation of sterile barrier system manufacturing process
11.1 Development of written process validation protocol
11.2 Performance of validation activities detailed in
protocol
11.3 Assessment of validation results
11.4 Approval of process validation
11.5 Establishment of documented ongoing process control
and monitoring
12 Final packaging system design validation
12.1 Packaging system design validation
12.2 Validation protocol
12.3 Performing testing
12.4 Documenting validation results
13 Revalidation
Annexes
A - Websites and references
B - Test method validation
C - Sterilization considerations
D - Design inputs-Device attributes and requirements
E - Selection, evaluation, and testing of packaging materials
sterile barrier systems
F - Investigating failure
G - Generating a final packaging system validation protocol
H - Risk analysis tools
I - Use of contract packagers
Annex J (Informative) - Guidance for health care facilities
J.1 Overview
J.2 Materials qualification
J.3 Design and development requirements for packaging systems
J.3.1 Design and development process
J.3.2 Performance and shelf life testing
J.4 Process validation
J.4.1 Guidance on validation
J.4.2 Pouch heat sealing - general
J.4.3 Self-sealing or taped pouch assembly
Annex K (Informative) - Addressing Worst-Case Requirements
K.1 Overview
K.2 Worst-case configuration - devices
K.3 Worst-case - sterile barrier system
K.4 Worst-case configuration - sterile barrier system
manufacturing process