BSI PD CEN ISO/TS 16775:2021 – TC:2022 Edition
$280.87
Tracked Changes. Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
| Published By | Publication Date | Number of Pages |
| BSI | 2022 | 422 |
This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2 . It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2 . This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities.
The guidance can be used to better understand the requirements of ISO 11607-1 and ISO 11607-2 and illustrates the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate conformity with them.
Guidance is given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given.
This document provides information for both healthcare facilities and the medical devices industry for terminally sterilized medical devices.
This document does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a โsterile fieldโ or transport of contaminated items, other regulatory standards will apply.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 30447897 |
| 269 | A-30421958 |
| 270 | National foreword |
| 272 | European foreword |
| 277 | Foreword |
| 278 | Introduction |
| 279 | 1 Scope 2 Normative references 3 Terms and definitions |
| 280 | 4 Guidance on Clauses 1-4 of ISO 11607โ1:2019 and ISO 11607โ2:2019 4.1 Scope (ISO 11607โ1:2019, Clause 1 and ISO 11607โ2:2019, Clause 1) 4.1.1 Intent 4.1.2 Guidance |
| 281 | 4.2 Normative references (ISO 11607โ1:2019, Clause 2 and ISO 11607โ2:2019, Clause 2) 4.2.1 Intent 4.2.2 Guidance |
| 282 | 4.3 Terms and definitions (ISO 11607โ1:2019, Clause 3 and ISO 11607โ2:2019, Clause 3) 4.3.1 Intent 4.3.2 Guidance 4.4 Quality and risk management (ISO 11607โ1:2019, 4.1, 4.2 and ISO 11607โ2:2019, 4.1, 4.2) 4.4.1 Intent 4.4.2 Guidance |
| 284 | 4.5 Sampling (ISO 11607โ1:2019, 4.3 and ISO 11607โ2:2019, 4.3) 4.5.1 Intent 4.5.2 Guidance |
| 285 | 4.6 Test methods (ISO 11607โ1:2019, 4.4 and ISO 11607โ2:2019, 4.4) 4.6.1 Intent 4.6.2 Guidance |
| 287 | 4.7 Documentation (ISO 11607โ1:2019, 4.5 and ISO 11607โ2:2019, 4.5) 4.7.1 Intent 4.7.2 Guidance |
| 288 | 5 Guidance on Clauses 5-11 of ISO 11607โ1:2019 5.1 General requirements for materials, preformed sterile barrier systems and sterile barrier systems (ISO 11607โ1:2019, 5.1.1 and 5.1.2) 5.1.1 Intent 5.1.2 Guidance 5.2 Conditions for production and handling (ISO 11607โ1:2019, 5.1.3 and 5.1.4) 5.2.1 Intent 5.2.2 Guidance |
| 289 | 5.3 Source, history and traceability of materials (ISO 11607โ1:2019, 5.1.5) 5.3.1 Intent 5.3.2 Guidance |
| 290 | 5.4 Properties to be evaluated (ISO 11607โ1:2019, 5.1.6) 5.4.1 Intent 5.4.2 Guidance 5.5 General performance requirements for materials (ISO 11607โ1:2019, 5.1.7 and 5.1.8) 5.5.1 Intent |
| 291 | 5.5.2 Guidance |
| 294 | 5.6 Additional requirements for sterile barrier systems and preformed sterile barrier systems (ISO 11607โ1:2019, 5.1.9) 5.6.1 Intent 5.6.2 Guidance |
| 295 | 5.7 Reusable sterile barrier systems (ISO 11607โ1:2019, 5.1.10, 5.1.11 and 5.1.12) 5.7.1 Intent 5.7.2 Guidance 5.8 Microbial barrier properties (ISO 11607โ1:2019, 5.2) 5.8.1 Intent 5.8.2 Guidance |
| 296 | 5.9 Compatibility with the sterilization process (ISO 11607โ1:2019, 5.3) 5.9.1 Intent 5.9.2 Guidance |
| 297 | 5.10 Labelling system (ISO 11607โ1:2019, 5.4) 5.10.1 Intent 5.10.2 Guidance |
| 299 | 5.11 Storage and transport of materials and preformed sterile barrier systems (ISO 11607โ1:2019, 5.5) 5.11.1 Intent 5.11.2 Guidance |
| 300 | 5.12 Design and development (ISO 11607โ1:2019, 6.1.1) 5.12.1 Intent 5.12.2 Guidance |
| 301 | 5.13 Aseptic presentation (ISO 11607โ1:2019, 6.1.2) 5.13.1 Intent 5.13.2 Guidance |
| 302 | 5.14 Physical protection (ISO 11607โ1:2019, 6.1.3 and 6.1.4) 5.14.1 Intent 5.14.2 Guidance |
| 303 | 5.15 Sterilization compatibility (ISO 11607โ1:2019, 6.1.5) 5.15.1 Intent 5.15.2 Guidance 5.16 Maintenance of Sterility (ISO 11607โ1:2019, 6.1.6 and 6.1.7) 5.16.1 Intent 5.16.2 Guidance |
| 304 | 5.17 Requirements for multi-layer packaging (ISO 11607โ1:2019, 6.1.8) 5.17.1 Intent 5.17.2 Guidance |
| 305 | 5.18 Packaging families (ISO 11607โ1:2019, 6.1.9) 5.18.1 Intent 5.18.2 Guidance |
| 306 | 5.19 Design process (ISO 11607โ1:2019, 6.2.1) 5.19.1 Intent |
| 307 | 5.19.2 Guidance 5.20 Design inputs (ISO 11607โ1:2019, 6.2.2 and 6.2.3) 5.20.1 Intent 5.20.2 Guidance |
| 309 | 5.21 Sterile fluid path (ISO 11607โ1:2019, 6.2.4, 6.2.5) 5.21.1 Intent 5.21.2 Guidance |
| 310 | 5.22 Usability evaluation for aseptic presentation (ISO 11607โ1:2019, 7.1, 7.2 and 7.3) 5.22.1 Intent 5.22.2 Guidance |
| 311 | 5.23 Leveraging usability evaluations (ISO 11607โ1:2019, 7.4) 5.23.1 Intent 5.23.2 Guidance 5.24 Usability evaluation failures (ISO 11607โ1:2019, 7.5) 5.24.1 Intent 5.24.2 Guidance |
| 312 | 5.24.3 Guidance on formative and summative studies |
| 313 | 5.25 Packaging system performance and stability (ISO 11607โ1:2019, 8.1) 5.25.1 Intent 5.25.2 Guidance |
| 315 | 5.26 Packaging system performance testing (ISO 11607โ1:2019, 8.2) 5.26.1 Intent 5.26.2 Guidance |
| 316 | 5.27 Stability testing (ISO 11607โ1:2019, 8.3) 5.27.1 Intent 5.27.2 Guidance |
| 318 | 5.28 Packaging system validation and changes (ISO 11607โ1:2019, 9.1) 5.28.1 Intent 5.28.2 Guidance 5.29 Change control (ISO 11607โ1:2019, 9.2) 5.29.1 Intent 5.29.2 Guidance 5.30 Revalidations (ISO 11607โ1:2019, 9.3, 9.4, and 9.5) 5.30.1 Intent 5.30.2 Guidance |
| 319 | 5.31 Inspection immediately prior to aseptic presentation (ISO 11607โ1:2019, Clause 10) 5.31.1 Intent 5.31.2 Guidance 5.32 Information to be provided (ISO 11607โ1:2019, Clause 11) 5.32.1 Intent 5.32.2 Guidance |
| 320 | 6 Guidance on Clauses 5-8 of ISO 11607โ2:2019 6.1 General Clauses 1-4 of ISO 11607โ2:2019 6.2 Validation of packaging processes โ general requirements (ISO 11607โ2:2019, 5.1.1 and 5.1.2) 6.2.1 Intent 6.2.2 Guidance |
| 321 | 6.3 Process specification (ISO 11607โ2:2019, 5.1.3) 6.3.1 Intent 6.3.2 Guidance 6.4 Process validation of packaging families (ISO 11607โ2:2019, 5.1.4) 6.4.1 Intent 6.4.2 Guidance |
| 322 | 6.5 Installation qualification (ISO 11607โ2:2019, 5.2) 6.5.1 Intent |
| 323 | 6.5.2 Guidance 6.6 Operational qualification (ISO 11607โ2:2019, 5.3) 6.6.1 Intent |
| 324 | 6.6.2 Guidance 6.7 Performance qualification (ISO 11607โ2:2019, 5.4) 6.7.1 Intent 6.7.2 Guidance |
| 325 | 6.8 Formal approval of the process validation (ISO 11607โ2:2019, 5.5) 6.8.1 Intent 6.8.2 Guidance |
| 326 | 6.9 Process control and monitoring (ISO 11607โ2:2019, 5.6) 6.9.1 Intent 6.9.2 Guidance 6.10 Process changes and revalidation (ISO 11607โ2:2019, 5.7) 6.10.1 Intent 6.10.2 Guidance |
| 327 | 6.11 Assembly (ISO 11607โ2:2019, Clause 6) 6.11.1 Intent 6.11.2 Guidance |
| 329 | 6.12 Use of reusable sterile barrier systems (ISO 11607โ2:2019, Clause 7) 6.12.1 Intent 6.12.2 Guidance 6.13 Sterile fluid path packaging (ISO 11607โ2:2019, Clause 8) 6.13.1 Intent 6.13.2 Guidance |
| 330 | Bibliography |
| 335 | Annex A (informative) Design and development for packaging systems โ guidance for industry |
| 343 | Annex B (informative) Guidance on the application of the ISO 11607 series in healthcare facilities |
| 374 | Annex C (informative) Risk analysis tools โ Guidance for industry and healthcare facilities |
| 376 | Annex D (informative) Considerations for sampling plans โ Guidance for healthcare facilities |
| 378 | Annex E (informative) Guidance on establishing process parameters โ guidance for industry |
| 384 | Annex F (informative) Sterilization considerations โ Guidance for industry and healthcare facilities |
| 391 | Annex G (informative) Use of contract packagers โ Guidance for industry and healthcare facilities |
| 392 | Annex H (informative) Example of a handling, distribution and storage checklist โ Guidance for healthcare facilities for selecting a sterile barrier system |
| 394 | Annex I (informative) Investigating failure โ Guidance for industry and healthcare facilities |
| 398 | Annex J (informative) Validation summary โ Guidance for healthcare facilities |
| 400 | Annex K (informative) Validation for wrapping process โ Guidance for healthcare facilities |
| 406 | Annex L (informative) Validation for reusable container process โ Guidance for healthcare facilities |
| 412 | Annex M (informative) Validation for heat sealing process for preformed sterile barrier systems (PSBS) โ Guidance for healthcare facilities |
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