ДСТУ EN ISO 81060-1:2015 Приборы неинвазивные для измерения кровяного давления. Часть 1. Общие требования и методы испытаний для моделей с неавтоматическим типом измерений (EN ISO 81060-1:2012, IDT; ISO 81060...

ДСТУ EN ISO 81060-1:2015
(EN ISO 81060-1:2012, IDT; ISO 81060-1:2007, IDT)

Прилади неінвазивні для вимірювання кров’яного тиску.
Частина 1. Загальні вимоги і методи випробування щодо моделей
з неавтоматичним типом вимірювання

 
   
 
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 Identification and marking

4.1 Units of measurement

4.2 Legibility of markings

4.3 Durability of markings

4.4 Marking of non-automated sphygmomanometer

4.5 Usability of reading

4.6 Marking of the cuff

4.7 Marking of the non-automated sphygmomanometer packaging

5 General requirements for testing non-automated sphygmomanometers

5.1 Type tests

5.2 Representative sample

5.3 Environmental conditions

5.4 Repairs and modifications

5.5 Humidity preconditioning treatment

6 General requirements

6.1 General

6.2 Electrical safety

6.3 Mechanical safety

6.4 Mechanical strength

7 Requirements

7.1 Pressure indicating means

7.2 Pneumatic system

7.3 Tamper proofing or unauthorized access

7.4 Dynamic response in normal use

8 Additional requirements for non-automated sphygmomanometer with mercury manometer

8.1 Internal diameter of the tube containing mercury

8.2 Portable non-automated sphygmomanometer

8.3 Prevention of mercury spillage during transport

8.4 Prevention of mercury spillage in normal use

8.5 Quality of the mercury

9 Non-automated sphygmomanometers with aneroid manometer

9.1 Scale mark at zero

9.2 Zero

9.3 Hysteresis error

9.4 Construction and materials

10 Cleaning, sterilization and disinfection

10.1 Reusable non-automated sphygmomanometer and parts

10.2 Non-automated sphygmomanometer and parts requiring processing before use

10.3 Non-automated sphygmomanometer and parts delivered sterile

11 Biocompatibility

12 Information supplied by the manufacturer

12.1 Accompanying document

12.2 Instructions for use

12.3 Technical description

Annex A (informative) Rationale and guidance

Annex B (informative) Advice regarding non-automated sphygmomanometers with a mercury manometer

Annex C (informative) Environmental aspects

Annex D (informative) Reference to the essential principals

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

Bibliography