SFS-EN ISO 10524-1:2019:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

ISO 10524-1:2018 specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
ISO 10524-1:2018 applies to pressure regulators:
a) intended to be connected to cylinders by the operator;
b) with integral flow-metering devices intended to be connected to cylinders by the operator;
c) that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators).
A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable or pre-set.
pressure regulators are intended to be fitted to refillable cylinders with a working pressure up to 30 000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the medical gas delivered.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements

5.1 Safety
5.2 Usability
5.3 Alternative construction
5.4 Materials

6 Design requirements

6.1 General
6.2 Indicator for cylinder pressure or cylinder content
6.3 Integrated electronic device
6.4 Connections
6.5 * Requirements for outlet pressure
6.6 Flow-metering device
6.7 Flow control and indication
6.8 Pressure-adjusting device
6.9 * Filtration
6.10 * Pressure-relief device
6.11 Leakage
6.12 Mechanical strength
6.13 * Resistance to ignition
6.14 Requirements for pressure regulators with flowmeters
6.15 Requirements for PRESSURE REGULATORS fitted with flowgauges
6.16 Requirements for pressure regulators fitted with fixed orifices
6.17 Endurance

7 Construction requirements

7.1 * Cleanliness
7.2 Lubricants
7.3 Loosening torques

8 Test methods for type tests

8.1 General conditions
8.2 Test schedule
8.3 Test methods for outlet pressure
8.4 Test method for a pressure-relief device
8.5 Test methods for leakage
8.6 Test method for mechanical strength
8.7 Test method for resistance to ignition
8.8 Test method for accuracy of flow of pressure regulators fitted with flowmeters or flowgauges
8.9 Test method for the stability of flow of pressure regulator fitted with flowmeters or flowgauges
8.10 Test method for stability and accuracy of flow of pressure regulators fitted with fixed orifices
8.11 Test method for flow setting and loosening torques
8.12 Test method for durability of markings and colour coding
8.13 *Flow selector endurance test
8.14 Pressure regulator endurance test

9 Marking, colour coding, and packaging

9.1 Marking
9.2 Colour coding
9.3 Packaging

10 Information to be supplied by the manufacturer

Annex A Rationale (informative)
Annex B Reported regional and national deviations of colour coding and nomenclature for medical gases (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements

5.1 Safety
5.2 Usability
5.3 Alternative construction
5.4 Materials

6 Design requirements

6.1 General
6.2 Indicator for cylinder pressure or cylinder content
6.3 Integrated electronic device
6.4 Connections
6.5 * Requirements for outlet pressure
6.6 Flow-metering device
6.7 Flow control and indication
6.8 Pressure-adjusting device
6.9 * Filtration
6.10 * Pressure-relief device
6.11 Leakage
6.12 Mechanical strength
6.13 * Resistance to ignition
6.14 Requirements for pressure regulators with flowmeters
6.15 Requirements for PRESSURE REGULATORS fitted with flowgauges
6.16 Requirements for pressure regulators fitted with fixed orifices
6.17 Endurance

7 Construction requirements

7.1 * Cleanliness
7.2 Lubricants
7.3 Loosening torques

8 Test methods for type tests

8.1 General conditions
8.2 Test schedule
8.3 Test methods for outlet pressure
8.4 Test method for a pressure-relief device
8.5 Test methods for leakage
8.6 Test method for mechanical strength
8.7 Test method for resistance to ignition
8.8 Test method for accuracy of flow of pressure regulators fitted with flowmeters or flowgauges
8.9 Test method for the stability of flow of pressure regulator fitted with flowmeters or flowgauges
8.10 Test method for stability and accuracy of flow of pressure regulators fitted with fixed orifices
8.11 Test method for flow setting and loosening torques
8.12 Test method for durability of markings and colour coding
8.13 *Flow selector endurance test
8.14 Pressure regulator endurance test

9 Marking, colour coding, and packaging

9.1 Marking
9.2 Colour coding
9.3 Packaging

10 Information to be supplied by the manufacturer

Annex A Rationale (informative)
Annex B Reported regional and national deviations of colour coding and nomenclature for medical gases (informative)

Bibliography

Tuoteryhmä(t)

11.040.10 Anestesia-, hengitys- ja elvytyskoneet »

Sidokset

Velvoittavat viittaukset

EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
EN 837-1:1996 Pressure gauges - Part 1: Bourdon tube pressure gauges - Dimensions, metrology, requirements and testing
IEC 60601-1:2005

Tekninen komitea

CEN/TC 215 Respiratory and anaesthetic equipment »

Vahvistuspäivä

08.02.2019

Julkaisupäivä

12.02.2019

Painos

2

Sivumäärä

40

Julkaisun kieli

englanti