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PD CEN ISO/TS 16775:2021 - TC Tracked Changes. Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2, 2022
- 30447897
- A-30421958 [Go to Page]
- National foreword
- European foreword
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Guidance on Clauses 1-4 of ISO 11607‑1:2019 and ISO 11607‑2:2019 [Go to Page]
- 4.1 Scope (ISO 11607‑1:2019, Clause 1 and ISO 11607‑2:2019, Clause 1) [Go to Page]
- 4.1.1 Intent
- 4.1.2 Guidance
- 4.2 Normative references (ISO 11607‑1:2019, Clause 2 and ISO 11607‑2:2019, Clause 2) [Go to Page]
- 4.2.1 Intent
- 4.2.2 Guidance
- 4.3 Terms and definitions (ISO 11607‑1:2019, Clause 3 and ISO 11607‑2:2019, Clause 3) [Go to Page]
- 4.3.1 Intent
- 4.3.2 Guidance
- 4.4 Quality and risk management (ISO 11607‑1:2019, 4.1, 4.2 and ISO 11607‑2:2019, 4.1, 4.2) [Go to Page]
- 4.4.1 Intent
- 4.4.2 Guidance
- 4.5 Sampling (ISO 11607‑1:2019, 4.3 and ISO 11607‑2:2019, 4.3) [Go to Page]
- 4.5.1 Intent
- 4.5.2 Guidance
- 4.6 Test methods (ISO 11607‑1:2019, 4.4 and ISO 11607‑2:2019, 4.4) [Go to Page]
- 4.6.1 Intent
- 4.6.2 Guidance
- 4.7 Documentation (ISO 11607‑1:2019, 4.5 and ISO 11607‑2:2019, 4.5) [Go to Page]
- 4.7.1 Intent
- 4.7.2 Guidance
- 5 Guidance on Clauses 5-11 of ISO 11607‑1:2019 [Go to Page]
- 5.1 General requirements for materials, preformed sterile barrier systems and sterile barrier systems (ISO 11607‑1:2019, 5.1.1 and 5.1.2) [Go to Page]
- 5.1.1 Intent
- 5.1.2 Guidance
- 5.2 Conditions for production and handling (ISO 11607‑1:2019, 5.1.3 and 5.1.4) [Go to Page]
- 5.2.1 Intent
- 5.2.2 Guidance
- 5.3 Source, history and traceability of materials (ISO 11607‑1:2019, 5.1.5) [Go to Page]
- 5.3.1 Intent
- 5.3.2 Guidance
- 5.4 Properties to be evaluated (ISO 11607‑1:2019, 5.1.6) [Go to Page]
- 5.4.1 Intent
- 5.4.2 Guidance
- 5.5 General performance requirements for materials (ISO 11607‑1:2019, 5.1.7 and 5.1.8) [Go to Page]
- 5.5.1 Intent
- 5.5.2 Guidance
- 5.6 Additional requirements for sterile barrier systems and preformed sterile barrier systems (ISO 11607‑1:2019, 5.1.9) [Go to Page]
- 5.6.1 Intent
- 5.6.2 Guidance
- 5.7 Reusable sterile barrier systems (ISO 11607‑1:2019, 5.1.10, 5.1.11 and 5.1.12) [Go to Page]
- 5.7.1 Intent
- 5.7.2 Guidance
- 5.8 Microbial barrier properties (ISO 11607‑1:2019, 5.2) [Go to Page]
- 5.8.1 Intent
- 5.8.2 Guidance
- 5.9 Compatibility with the sterilization process (ISO 11607‑1:2019, 5.3) [Go to Page]
- 5.9.1 Intent
- 5.9.2 Guidance
- 5.10 Labelling system (ISO 11607‑1:2019, 5.4) [Go to Page]
- 5.10.1 Intent
- 5.10.2 Guidance
- 5.11 Storage and transport of materials and preformed sterile barrier systems (ISO 11607‑1:2019, 5.5) [Go to Page]
- 5.11.1 Intent
- 5.11.2 Guidance
- 5.12 Design and development (ISO 11607‑1:2019, 6.1.1) [Go to Page]
- 5.12.1 Intent
- 5.12.2 Guidance
- 5.13 Aseptic presentation (ISO 11607‑1:2019, 6.1.2) [Go to Page]
- 5.13.1 Intent
- 5.13.2 Guidance
- 5.14 Physical protection (ISO 11607‑1:2019, 6.1.3 and 6.1.4) [Go to Page]
- 5.14.1 Intent
- 5.14.2 Guidance
- 5.15 Sterilization compatibility (ISO 11607‑1:2019, 6.1.5) [Go to Page]
- 5.15.1 Intent
- 5.15.2 Guidance
- 5.16 Maintenance of Sterility (ISO 11607‑1:2019, 6.1.6 and 6.1.7) [Go to Page]
- 5.16.1 Intent
- 5.16.2 Guidance
- 5.17 Requirements for multi-layer packaging (ISO 11607‑1:2019, 6.1.8) [Go to Page]
- 5.17.1 Intent
- 5.17.2 Guidance
- 5.18 Packaging families (ISO 11607‑1:2019, 6.1.9) [Go to Page]
- 5.18.1 Intent
- 5.18.2 Guidance
- 5.19 Design process (ISO 11607‑1:2019, 6.2.1) [Go to Page]
- 5.19.1 Intent
- 5.19.2 Guidance
- 5.20 Design inputs (ISO 11607‑1:2019, 6.2.2 and 6.2.3) [Go to Page]
- 5.20.1 Intent
- 5.20.2 Guidance
- 5.21 Sterile fluid path (ISO 11607‑1:2019, 6.2.4, 6.2.5) [Go to Page]
- 5.21.1 Intent
- 5.21.2 Guidance
- 5.22 Usability evaluation for aseptic presentation (ISO 11607‑1:2019, 7.1, 7.2 and 7.3) [Go to Page]
- 5.22.1 Intent
- 5.22.2 Guidance
- 5.23 Leveraging usability evaluations (ISO 11607‑1:2019, 7.4) [Go to Page]
- 5.23.1 Intent
- 5.23.2 Guidance
- 5.24 Usability evaluation failures (ISO 11607‑1:2019, 7.5) [Go to Page]
- 5.24.1 Intent
- 5.24.2 Guidance
- 5.24.3 Guidance on formative and summative studies
- 5.25 Packaging system performance and stability (ISO 11607‑1:2019, 8.1) [Go to Page]
- 5.25.1 Intent
- 5.25.2 Guidance
- 5.26 Packaging system performance testing (ISO 11607‑1:2019, 8.2) [Go to Page]
- 5.26.1 Intent
- 5.26.2 Guidance
- 5.27 Stability testing (ISO 11607‑1:2019, 8.3) [Go to Page]
- 5.27.1 Intent
- 5.27.2 Guidance
- 5.28 Packaging system validation and changes (ISO 11607‑1:2019, 9.1) [Go to Page]
- 5.28.1 Intent
- 5.28.2 Guidance
- 5.29 Change control (ISO 11607‑1:2019, 9.2) [Go to Page]
- 5.29.1 Intent
- 5.29.2 Guidance
- 5.30 Revalidations (ISO 11607‑1:2019, 9.3, 9.4, and 9.5) [Go to Page]
- 5.30.1 Intent
- 5.30.2 Guidance
- 5.31 Inspection immediately prior to aseptic presentation (ISO 11607‑1:2019, Clause 10) [Go to Page]
- 5.31.1 Intent
- 5.31.2 Guidance
- 5.32 Information to be provided (ISO 11607‑1:2019, Clause 11) [Go to Page]
- 5.32.1 Intent
- 5.32.2 Guidance
- 6 Guidance on Clauses 5-8 of ISO 11607‑2:2019 [Go to Page]
- 6.1 General Clauses 1-4 of ISO 11607‑2:2019
- 6.2 Validation of packaging processes – general requirements (ISO 11607‑2:2019, 5.1.1 and 5.1.2) [Go to Page]
- 6.2.1 Intent
- 6.2.2 Guidance
- 6.3 Process specification (ISO 11607‑2:2019, 5.1.3) [Go to Page]
- 6.3.1 Intent
- 6.3.2 Guidance
- 6.4 Process validation of packaging families (ISO 11607‑2:2019, 5.1.4) [Go to Page]
- 6.4.1 Intent
- 6.4.2 Guidance
- 6.5 Installation qualification (ISO 11607‑2:2019, 5.2) [Go to Page]
- 6.5.1 Intent
- 6.5.2 Guidance
- 6.6 Operational qualification (ISO 11607‑2:2019, 5.3) [Go to Page]
- 6.6.1 Intent
- 6.6.2 Guidance
- 6.7 Performance qualification (ISO 11607‑2:2019, 5.4) [Go to Page]
- 6.7.1 Intent
- 6.7.2 Guidance
- 6.8 Formal approval of the process validation (ISO 11607‑2:2019, 5.5) [Go to Page]
- 6.8.1 Intent
- 6.8.2 Guidance
- 6.9 Process control and monitoring (ISO 11607‑2:2019, 5.6) [Go to Page]
- 6.9.1 Intent
- 6.9.2 Guidance
- 6.10 Process changes and revalidation (ISO 11607‑2:2019, 5.7) [Go to Page]
- 6.10.1 Intent
- 6.10.2 Guidance
- 6.11 Assembly (ISO 11607‑2:2019, Clause 6) [Go to Page]
- 6.11.1 Intent
- 6.11.2 Guidance
- 6.12 Use of reusable sterile barrier systems (ISO 11607‑2:2019, Clause 7) [Go to Page]
- 6.12.1 Intent
- 6.12.2 Guidance
- 6.13 Sterile fluid path packaging (ISO 11607‑2:2019, Clause 8) [Go to Page]
- 6.13.1 Intent
- 6.13.2 Guidance
- Bibliography
- Annex A (informative) Design and development for packaging systems – guidance for industry
- Annex B (informative) Guidance on the application of the ISO 11607 series in healthcare facilities
- Annex C (informative) Risk analysis tools — Guidance for industry and healthcare facilities
- Annex D (informative) Considerations for sampling plans – Guidance for healthcare facilities
- Annex E (informative) Guidance on establishing process parameters – guidance for industry
- Annex F (informative) Sterilization considerations – Guidance for industry and healthcare facilities
- Annex G (informative) Use of contract packagers – Guidance for industry and healthcare facilities
- Annex H (informative) Example of a handling, distribution and storage checklist – Guidance for healthcare facilities for selecting a sterile barrier system
- Annex I (informative) Investigating failure – Guidance for industry and healthcare facilities
- Annex J (informative) Validation summary – Guidance for healthcare facilities
- Annex K (informative) Validation for wrapping process — Guidance for healthcare facilities
- Annex L (informative) Validation for reusable container process – Guidance for healthcare facilities
- Annex M (informative) Validation for heat sealing process for preformed sterile barrier systems (PSBS) – Guidance for healthcare facilities [Go to Page]
