ДСТУ CEN ISO/TS 16775:2019 Паковання для термічно стерилізованих медичних виробів. Настанова щодо застосування ІSO 11607-1 та ІSO 11607-2 (CEN ISO/TS 16775:2014, IDT; ISO/TS 16775:2014, IDT)

ДСТУ CEN ISO/TS 16775:2019
(CEN ISO/TS 16775:2014, IDT; ISO/TS 16775:2014, IDT)

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

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

Contents

Foreword

Introduction

1 Scope

2 Terms and definitions

3 Guidance for health care facilities

3.1 Test methods

3.2 Guidance for conformance to ISO 11607-1

3.3 Guidance on conformance to ISO 11607-2, Validation requirements for forming, sealing and assembly processes

3.4 Quality system

4 Guidance for industry

4.1 General guidance

4.2 Design inputs

4.3 Selection and evaluation of materials

4.4 Sterile barrier system and protective packaging design (packaging system development)

4.5 Packaging process feasibility evaluation

4.6 Sterile barrier system design feasibility evaluation

4.7 Validation of sterile barrier system manufacturing process

4.8 Packaging system design validation

4.9 Revalidation

Annex A (informative) Selection, evaluation and testing of packaging materials and sterile barrier systems — Guidance for industry and health care facilities

Annex B (informative) Sterilization considerations — Guidance for industry and health care facilities

Annex C (informative) Examples of wrapping methods — Guidance for health care facilities

Annex D (informative) Validation plan documents — Guidance for health care facilities

Annex E (informative) Installation qualification documentation — Guidance for health care facilities

Annex F (informative) Operational qualification documentation — Guidance for health care facilities

Annex G (informative) Performance qualification documentation — Guidance for health care facilities

Annex H (informative) Addressing worst-case requirements — Guidance for industry and health care facilities

Annex I (informative) Generating a final packaging system validation protocol — Guidance for industry

Annex J (informative) Design inputs — Medical device attributes — Guidance for industry

Annex K (informative) Risk analysis tools — Guidance for industry and health care facilities

Annex L (informative) Considerations for sampling plans — Guidance for health care facilities

Annex M (informative) Stability testing (ISO 11607-1:2006, 6.4) — Guidance for industry

Annex N (informative) Use of the Internet — Guidance for industry and health care facilities

Annex O (informative) Test method validation — Guidance for industry

Annex P (informative) Use of contract packagers — Guidance for industry and health care facilities

Annex Q (informative) Guidance on establishing process parameters — Guidance for industry

Annex R (informative) Investigation failure — Guidance for industry and health care facilities

Annex S (informative) Packaging manufacturing process and packaging system design feasibility evaluation — Guidance for industry

Bibliography