ДСТУ EN ISO 21976:2022 Упаковка. Функции проверки целостности упаковки лекарственных средств (EN ISO 21976:2020, IDT; ISO 21976:2020, IDT)

ДСТУ EN ISO 21976:2022
(EN ISO 21976:2020, IDT; ISO 21976:2020, IDT)

Упаковка. Функції перевірки цілісності упаковки лікарських засобів

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

Contents

European foreword

Foreword

Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 General requirements

4.1 Tamper verification features

4.2 Purpose of tamper verification features

4.3 Application and use of tamper verification features

4.4 Check of tamper verification features

5 Categories of tamper verification features

5.1 General

5.2 Folding boxes closed with glue

5.2.1 Description

5.2.2 Criteria of tamper verification

5.2.3 Verification

5.3 Specially constructed folding boxes

5.3.1 Description

5.3.2 Criteria of tamper verification

5.3.3 Verification

5.4 Sealing labels and tapes

5.4.1 Description

5.4.2 Criteria of tamper verification

5.4.3 Verification

5.5 Film wrappers

5.5.1 Description

5.5.2 Criteria of tamper verification

5.5.3 Verification

5.6 Sleeves

5.6.1 Description

5.6.2 Criteria of tamper verification

5.6.3 Verification

5.7 Breakable or tear-away closure

5.7.1 Description

5.7.2 Criteria of tamper verification

5.7.3 Verification

5.8 Container inner seal or membrane

5.8.1 Description

5.8.2 Criteria of tamper verification

5.8.3 Verification

5.9 Display blister pack

5.9.1 Description

5.9.2 Criteria of tamper verification

5.9.3 Verification

5.10 Flexible packaging

5.10.1 Description

5.10.2 Criteria of tamper verification

5.10.3 Verification

5.11 Blow-fill-and-seal-container (BFS)

5.11.1 Description

5.11.2 Criteria of tamper verification

5.11.3 Verification

5.12 New and emerging technologies

Annex A (informative) Additional information regarding tamper verification features

Bibliography