ДСТУ EN ISO 20417:2022 Медицинские изделия. Информация, предоставляемая производителем (EN ISO 20417:2021, IDT; ISO 20417:2021)



ДСТУ EN ISO 20417:2022
(EN ISO 20417:2021, IDT; ISO 20417:2021, Corrected version 2021-12, IDT)

Вироби медичні. Інформація, яку надає виробник

 

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

Contents

Foreword

Introduction

2 Normative references

3 Terms and definitions

4 General considerations

5 Information elements to be established

5.1 Units of measurement

5.2 Graphical information

5.3 Language and country identifiers

5.4 Dates

5.5 Full address

5.6 Commercial product name

5.7 Model number

5.8 Catalogue number

5.9 Production controls

5.10 Unique device identifier

5.11 Types of use/reuse

5.12 Sterile

6 Requirements for accompanying information

6.1 Requirements for information to be supplied on the label

6.2 Identification requirements for detachable components of a medical device or accessory

6.3 Legibility of the label

6.4 Durability of markings

6.5 Information to be provided on the packaging

6.6 Requirements for information in the instructions for use and technical description

7 Other information that is required to be supplied with the medical device or accessory

7.1 Importer

7.2 Distributor

7.3 Repackaging

7.4 Translation

7.5 Regulatory identification

Annex A (informative) Particular guidance and rationale

Annex В (informative) Example test method for assessing clearly legible requirements

Annex C (informative) Example test method for assessing durability

Annex D (informative) Cross reference between the document and the requirements considered

Annex E (informative) Reference to the IMDRF essential principles and labelling guidances

Annex F (informative) Reference to the essential principles

Annex G (informative) Reference to the general safety and performance requirements for medical devices

Annex H (informative) Reference to the general safety and performance requirements for IVD medical devices

Annex I (informative) Terminology — Alphabetized index of defined terms

Bibliography