ДСТУ CEN ISO/TS 16775:2022 Паковання для термічно стерилізованих медичних виробів. Настанова щодо застосування ISO 11607-1 та ISO 11607-2 (CEN ISO/TS 16775:2021, IDT; ISO/TS 16775:2021, IDT)



ПІДТВЕРДЖУВАЛЬНЕ ПОВІДОМЛЕННЯ

Державне підприємство
«Український науково-дослідний і навчальний центр
проблем стандартизації, сертифікації та якості»
(ДП «УкрНДНЦ»)

Наказ від 28.12.2022 № 285

CEN ISO/TS 16775:2021

Packaging for terminally sterilized medical devices -
Guidance on the application of
ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)

прийнято як національний стандарт
методом «підтвердження» за позначенням

ДСТУ CEN ISO/TS 16775:2022
(CEN ISO/TS 16775:2021, IDT; ISO/TS 16775:2021, IDT)

Паковання для термічно стерилізованих медичних виробів.
Настанова щодо застосування ISO 11607-1 та ISO 11607-2

З наданням чинності від 2023-12-31

 

 
 
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

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

4.1 Scope (ISO 11607-1:2019, Clause 1 and ISO 11607-2:2019, Clause 1)

4.2 Normative references (ISO 11607-1:2019, Clause 2 and ISO 11607-2:2019, Clause 2)

4.3 Terms and definitions (ISO 11607-1:2019, Clause 3 and ISO 11607-2:2019, Clause 3)

4.4 Quality and risk management (ISO 11607-1:2019, 4.1, 4.2 and ISO 11607-2:2019, 4.1, 4.2)

4.5 Sampling (ISO 11607-1:2019,4.3 and ISO 11607-2:2019, 4.3)

4.6 Test methods (ISO 11607-1:2019,4.4 and ISO 11607-2:2019, 4.4)

4.7 Documentation (ISO 11607-1:2019, 4.5 and ISO 11607-2:2019, 4.5)

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)

5.2 Conditions for production and handling (ISO 11607-1:2019, 5.1.3 and 5.1.4)

5.3 Source, history and traceability of materials (ISO 11607-1:2019,5.1.5)

5.4 Properties to be evaluated (ISO 11607-1:2019, 5.1.6)

5.5 General performance requirements for materials (ISO 11607-1:2019, 5.1.7 and 5.1.8)

5.6 Additional requirements for sterile barrier systems and preformed sterile barrier systems (ISO 11607-1:2019,5.1.9)

5.7 Reusable sterile barrier systems (ISO 11607-1:2019, 5.1.10, 5.1.11 and 5.1.12)

5.8 Microbial barrier properties (ISO 11607-1:2019, 5.2)

5.9 Compatibility with the sterilization process (ISO 11607-1:2019, 5.3)

5.10 Labelling system (ISO 11607-1:2019, 5.4)

5.11 Storage and transport of materials and preformed sterile barrier systems (ISO 11607-1:2019, 5.5)

5.12 Design and development (ISO 11607-1:2019, 6.1.1)

5.13 Aseptic presentation (ISO 11607-1:2019, 6.1.2)

5.14 Physical protection (ISO 11607-1:2019, 6.1.3 and 6.1.4)

5.15 Sterilization compatibility (ISO 11607-1:2019, 6.1.5)

5.16 Maintenance of Sterility (ISO 11607-1:2019, 6.1.6 and 6.1.7)

5.17 Requirements for multi-layer packaging (ISO 11607-1:2019, 6.1.8)

5.18 Packaging families (ISO 11607-1:2019,6.1.9)

5.19 Design process (ISO 11607-1:2019, 6.2.1)

5.20 Design inputs (ISO 11607-1:2019, 6.2.2 and 6.2.3)

5.21 Sterile fluid path (ISO 11607-1:2019, 6.2.4, 6.2.5)

5.22 Usability evaluation for aseptic presentation (ISO 11607-1:2019, 7.1, 7.2 and 7.3)

5.23 Leveraging usability evaluations (ISO 11607-1:2019, 7.4)

5.24 Usability evaluation failures (ISO 11607-1:2019, 7.5)

5.25 Packaging system performance and stability (ISO 11607-1:2019, 8.1)

5.26 Packaging system performance testing (ISO 11607-1:2019, 8.2)

5.27 Stability testing (ISO 11607-1:2019,8.3)

5.28 Packaging system validation and changes (ISO 11607-1:2019, 9.1)

5.29 Change control (ISO 11607-1:2019, 9.2)

5.30 Revalidations (ISO 11607-1:2019, 9.3, 9.4, and 9.5)

5.31 Inspection immediately prior to aseptic presentation (ISO 11607-1:2019, Clause 10)

5.32 Information to be provided (ISO 11607-1:2019, Clause 11)

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)

6.3 Process specification (ISO 11607-2:2019, 5.1.3)

6.4 Process validation of packaging families (ISO 11607-2:2019, 5.1.4)

6.5 Installation qualification (ISO 11607-2:2019, 5.2)

6.6 Operational qualification (ISO 11607-2:2019, 5.3)

6.7 Performance qualification (ISO 11607-2:2019, 5.4)

6.8 Formal approval of the process validation (ISO 11607-2:2019, 5.5)

6.9 Process control and monitoring (ISO 11607-2:2019, 5.6)

6.10 Process changes and revalidation (ISO 11607-2:2019, 5.7)

6.11 Assembly (ISO 11607-2:2019, Clause 6)

6.12 Use of reusable sterile barrier systems (ISO 11607-2:2019, Clause 7)

6.13 Sterile fluid path packaging (ISO 11607-2:2019, Clause 8)

Annex A (informative) Design and development for packaging systems - guidance for industry

Annex В (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 К (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

Annex N (informative) Evaluation of sterile packaging by end users — Guidance for healthcare facilities

Bibliography