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 “sterile field” or transport of contaminated items, other regulatory standards will apply.

PDF Catalog

PDF Pages	PDF Title
2	National foreword
4	European foreword
9	Foreword
10	Introduction
11	1 Scope 2 Normative references 3 Terms and definitions
12	4 Guidance on Clauses 1-4 of ISO 11607‑1:2019 and ISO 11607‑2:2019 4.1 Scope (ISO 11607‑1:2019, Clause 1 and ISO 11607‑2:2019, Clause 1) 4.1.1 Intent 4.1.2 Guidance
13	4.2 Normative references (ISO 11607‑1:2019, Clause 2 and ISO 11607‑2:2019, Clause 2) 4.2.1 Intent 4.2.2 Guidance
14	4.3 Terms and definitions (ISO 11607‑1:2019, Clause 3 and ISO 11607‑2:2019, Clause 3) 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) 4.4.1 Intent 4.4.2 Guidance
16	4.5 Sampling (ISO 11607‑1:2019, 4.3 and ISO 11607‑2:2019, 4.3) 4.5.1 Intent 4.5.2 Guidance
17	4.6 Test methods (ISO 11607‑1:2019, 4.4 and ISO 11607‑2:2019, 4.4) 4.6.1 Intent 4.6.2 Guidance
19	4.7 Documentation (ISO 11607‑1:2019, 4.5 and ISO 11607‑2:2019, 4.5) 4.7.1 Intent 4.7.2 Guidance
20	5 Guidance on Clauses 5-11 of ISO 11607‑1:2019 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) 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) 5.2.1 Intent 5.2.2 Guidance
21	5.3 Source, history and traceability of materials (ISO 11607‑1:2019, 5.1.5) 5.3.1 Intent 5.3.2 Guidance
22	5.4 Properties to be evaluated (ISO 11607‑1:2019, 5.1.6) 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) 5.5.1 Intent
23	5.5.2 Guidance
26	5.6 Additional requirements for sterile barrier systems and preformed sterile barrier systems (ISO 11607‑1:2019, 5.1.9) 5.6.1 Intent 5.6.2 Guidance
27	5.7 Reusable sterile barrier systems (ISO 11607‑1:2019, 5.1.10, 5.1.11 and 5.1.12) 5.7.1 Intent 5.7.2 Guidance 5.8 Microbial barrier properties (ISO 11607‑1:2019, 5.2) 5.8.1 Intent 5.8.2 Guidance
28	5.9 Compatibility with the sterilization process (ISO 11607‑1:2019, 5.3) 5.9.1 Intent 5.9.2 Guidance
29	5.10 Labelling system (ISO 11607‑1:2019, 5.4) 5.10.1 Intent 5.10.2 Guidance
31	5.11 Storage and transport of materials and preformed sterile barrier systems (ISO 11607‑1:2019, 5.5) 5.11.1 Intent 5.11.2 Guidance
32	5.12 Design and development (ISO 11607‑1:2019, 6.1.1) 5.12.1 Intent 5.12.2 Guidance
33	5.13 Aseptic presentation (ISO 11607‑1:2019, 6.1.2) 5.13.1 Intent 5.13.2 Guidance
34	5.14 Physical protection (ISO 11607‑1:2019, 6.1.3 and 6.1.4) 5.14.1 Intent 5.14.2 Guidance
35	5.15 Sterilization compatibility (ISO 11607‑1:2019, 6.1.5) 5.15.1 Intent 5.15.2 Guidance 5.16 Maintenance of Sterility (ISO 11607‑1:2019, 6.1.6 and 6.1.7) 5.16.1 Intent 5.16.2 Guidance
36	5.17 Requirements for multi-layer packaging (ISO 11607‑1:2019, 6.1.8) 5.17.1 Intent 5.17.2 Guidance
37	5.18 Packaging families (ISO 11607‑1:2019, 6.1.9) 5.18.1 Intent 5.18.2 Guidance
38	5.19 Design process (ISO 11607‑1:2019, 6.2.1) 5.19.1 Intent
39	5.19.2 Guidance 5.20 Design inputs (ISO 11607‑1:2019, 6.2.2 and 6.2.3) 5.20.1 Intent 5.20.2 Guidance
41	5.21 Sterile fluid path (ISO 11607‑1:2019, 6.2.4, 6.2.5) 5.21.1 Intent 5.21.2 Guidance
42	5.22 Usability evaluation for aseptic presentation (ISO 11607‑1:2019, 7.1, 7.2 and 7.3) 5.22.1 Intent 5.22.2 Guidance
43	5.23 Leveraging usability evaluations (ISO 11607‑1:2019, 7.4) 5.23.1 Intent 5.23.2 Guidance 5.24 Usability evaluation failures (ISO 11607‑1:2019, 7.5) 5.24.1 Intent 5.24.2 Guidance
44	5.24.3 Guidance on formative and summative studies
45	5.25 Packaging system performance and stability (ISO 11607‑1:2019, 8.1) 5.25.1 Intent 5.25.2 Guidance
47	5.26 Packaging system performance testing (ISO 11607‑1:2019, 8.2) 5.26.1 Intent 5.26.2 Guidance
48	5.27 Stability testing (ISO 11607‑1:2019, 8.3) 5.27.1 Intent 5.27.2 Guidance
50	5.28 Packaging system validation and changes (ISO 11607‑1:2019, 9.1) 5.28.1 Intent 5.28.2 Guidance 5.29 Change control (ISO 11607‑1:2019, 9.2) 5.29.1 Intent 5.29.2 Guidance 5.30 Revalidations (ISO 11607‑1:2019, 9.3, 9.4, and 9.5) 5.30.1 Intent 5.30.2 Guidance
51	5.31 Inspection immediately prior to aseptic presentation (ISO 11607‑1:2019, Clause 10) 5.31.1 Intent 5.31.2 Guidance 5.32 Information to be provided (ISO 11607‑1:2019, Clause 11) 5.32.1 Intent 5.32.2 Guidance
52	6 Guidance on Clauses 5-8 of ISO 11607‑2:2019 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) 6.2.1 Intent 6.2.2 Guidance
53	6.3 Process specification (ISO 11607‑2:2019, 5.1.3) 6.3.1 Intent 6.3.2 Guidance 6.4 Process validation of packaging families (ISO 11607‑2:2019, 5.1.4) 6.4.1 Intent 6.4.2 Guidance
54	6.5 Installation qualification (ISO 11607‑2:2019, 5.2) 6.5.1 Intent
55	6.5.2 Guidance 6.6 Operational qualification (ISO 11607‑2:2019, 5.3) 6.6.1 Intent
56	6.6.2 Guidance 6.7 Performance qualification (ISO 11607‑2:2019, 5.4) 6.7.1 Intent 6.7.2 Guidance
57	6.8 Formal approval of the process validation (ISO 11607‑2:2019, 5.5) 6.8.1 Intent 6.8.2 Guidance
58	6.9 Process control and monitoring (ISO 11607‑2:2019, 5.6) 6.9.1 Intent 6.9.2 Guidance 6.10 Process changes and revalidation (ISO 11607‑2:2019, 5.7) 6.10.1 Intent 6.10.2 Guidance
59	6.11 Assembly (ISO 11607‑2:2019, Clause 6) 6.11.1 Intent 6.11.2 Guidance
61	6.12 Use of reusable sterile barrier systems (ISO 11607‑2:2019, Clause 7) 6.12.1 Intent 6.12.2 Guidance 6.13 Sterile fluid path packaging (ISO 11607‑2:2019, Clause 8) 6.13.1 Intent 6.13.2 Guidance
62	Bibliography
67	Annex A (informative) Design and development for packaging systems – guidance for industry
75	Annex B (informative) Guidance on the application of the ISO 11607 series in healthcare facilities
106	Annex C (informative) Risk analysis tools — Guidance for industry and healthcare facilities
108	Annex D (informative) Considerations for sampling plans – Guidance for healthcare facilities
110	Annex E (informative) Guidance on establishing process parameters – guidance for industry
116	Annex F (informative) Sterilization considerations – Guidance for industry and healthcare facilities
123	Annex G (informative) Use of contract packagers – Guidance for industry and healthcare facilities
124	Annex H (informative) Example of a handling, distribution and storage checklist – Guidance for healthcare facilities for selecting a sterile barrier system
126	Annex I (informative) Investigating failure – Guidance for industry and healthcare facilities
130	Annex J (informative) Validation summary – Guidance for healthcare facilities
132	Annex K (informative) Validation for wrapping process — Guidance for healthcare facilities
138	Annex L (informative) Validation for reusable container process – Guidance for healthcare facilities
144	Annex M (informative) Validation for heat sealing process for preformed sterile barrier systems (PSBS) – Guidance for healthcare facilities

Published By	Publication Date	Number of Pages
BSI	2021	154


PDF Format	Searchable	Printable	Preview Now

Status	Definitive
Pages	154
Publication Date	2021-11-26
ISBN	978 0 539 14192 4
Standard Number	PD CEN ISO/TS 16775:2021
Title	Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
Identical National Standard Of	CENISO/TS 16775, ISO/TS 16775
Replaces	PD CEN ISO/TS 16775:2014
Descriptors	Sterilization (hygiene), Acceptance (approval), Medical instruments, Sterile equipment, Packaging processes, Test methods, Quality assurance systems, Seals, Performance, Packages, Wrapping, Sealing processes, Compatibility, Verification, Design, Medical equipment, Packaging materials, Quality, Performance testing, Packaging
Publisher	BSI
Committee	CH/198
ICS Codes	11.080.30 - Sterilized packaging

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