ДСТУ EN ISO 5366:2019 Анестезиологическое и респираторное оборудование. Трахеостомические трубки и соединители (EN ISO 5366:2016, IDT; ISO 5366:2016, IDT)



ДСТУ EN ISO 5366:2019
(EN ISO 5366:2016, IDT; ISO 5366:2016, IDT)

Анестезіологічне та респіраторне обладнання.
Трахеостомічні трубки та з’єднувачі

 

 
   
 
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 General requirements for tracheostomy tubes and connectors

5 Materials

6 Design requirements for tracheostomy tubes and connectors

6.1 General design requirements

6.2 Size designation and dimensions

6.3 Design

7 Requirements for tracheostomy tubes supplied sterile

7.1 Sterility assurance

7.2 Packaging for tracheostomy tubes supplied sterile

8 Information supplied by the manufacturer

8.1 General

8.2 Marking of neck-plate

8.3 Marking on the inflation indicator

8.4 Marking of tracheostomy tube connectors

8.5 Additional labelling of unit packs

8.6 Labelling of inner tube unit packs

8.7 Labelling of tracheostomy tube inserts

Annex A (informative) Rationale

Annex B (normative) Test method for the security of attachment of a fitted connector and neck-plate to the tracheostomy tube

Annex C (normative) Test method for determining the diameter of the cuff

Annex D (normative) Test method for cuff herniation

Annex E (normative) Test method for determining kink resistance

Annex F (informative) Guidance on materials and design

Annex G (informative) Hazard identification for risk assessment

Bibliography