CSA Z10524-1:19

(ISO 10524-1:2018, MOD)

National Standard of Canada

CSA Z10524-1:19

Pressure regulators for use with medical gases — Part 1:

Pressure regulators and pressure regulators with flow-metering devices

(ISO 10524-1:2018, MOD)

© ISO 2018. © Canadian Standards Association 2019. All rights reserved. Unauthorized reproduction is strictly prohibited.

Contents Page

Foreword v

Introduction vi

1. Scope 1

2. Normative references 1

3. Terms and definitions 2

4. Nomenclature 4

5. General requirements 4

   1. Safety 4

   2. Usability 4

1. Alternative construction 4

2. Materials 4

6 Design requirements 5

6.1 General 5

1. Indicator for cylinder pressure or cylinder content 6

   1. General 6

   2. Pressure gauges, pressure indicators, and flowgauges 6

1. Integrated electronic device 6

2. Connections 6

   1. Inlet connector 6

   2. Outlet connectors 7

3. * Requirements for outlet pressure 7

   1. Pressure outlet 7

   2. Flow outlet 8

4. Flow-metering device 8

5. Flow control and indication 8

6. Pressure-adjusting device 8

7. * Filtration 9

8. * Pressure-relief device 9

9. Leakage 9

10. Mechanical strength 10

    1. Resistance of the high-pressure side 10

    2. Resistance of the low-pressure side to pneumatic pressure 10

    3. Resistance of the low-pressure side to inlet pressure, P1 10

11. * Resistance to ignition 10

12. Requirements for pressure regulators with flowmeters 10

    1. Calibration 10

    2. Accuracy of flow 10

1. Stability of flow 11

2. Legibility 11

6.14.5 Flow control device 11

1. Requirements for PRESSURE REGULATORS fitted with flowgauges 11

   1. Calibration 11

   2. Accuracy of flow 11

      6.15.3 Stability of flow 11

2. Requirements for pressure regulators fitted with fixed orifices 12

6.16.1 Stability and accuracy of flow 12

6.16.2 * Flow setting torque 12

1. Removal of a fixed orifice 12

2. Legibility 12

1. Endurance 12

   1. Flow selector 12

   2. Pressure regulator 13

1. Construction requirements 13

   1. * Cleanliness 13

   2. Lubricants 13

   3. Loosening torques 13

2. Test methods for type tests 14

   1. General conditions 14

      1. General 14

      2. Ambient conditions 14

      3. Test gas 14

      4. Reference conditions 14

   2. Test schedule 14

   3. Test methods for outlet pressure 16

      1. Test equipment 16

      2. Test methods for determining outlet pressure limits for a pressure

         regulator fitted with a pressure outlet 17

      3. Test method for determining the outlet pressure limit for a pressure

         regulator fitted with a flow outlet 18

   4. Test method for a pressure-relief device 18

   5. Test methods for leakage 18

      1. External leakage 18

      2. Internal leakage 19

   6. Test method for mechanical strength 19

      1. Test method for the high-pressure side 19

      2. Test method for resistance of the low-pressure side to pneumatic pressure 19

      3. Test method for the resistance of the low pressure side to P1 19

   7. Test method for resistance to ignition 20

      1. General 20

      2. Test procedure for adjustable and pre-set pressure regulators 20

   8. Test method for accuracy of flow of pressure regulators fitted with

flowmeters or flowgauges 20

1. Test method for the stability of flow of pressure regulator fitted with

   flowmeters or flowgauges 20

2. Test method for stability and accuracy of flow of pressure regulators fitted

   with fixed orifices 21

3. Test method for flow setting and loosening torques 21

   8.11.1 General 21

   8.11.2 Test method for verifying no stable position between two settings 21

4. Test method for durability of markings and colour coding 21

1. *Flow selector endurance test 21

2. Pressure regulator endurance test 22

1. Marking, colour coding, and packaging 22

   1. Marking 22

   2. Colour coding 24

   3. Packaging 24

2. Information to be supplied by the manufacturer 24

Annex A (informative) Rationale 26

Annex B (informative) Reported regional and national deviations of colour coding and nomenclature for medical gases 31

Bibliography 33

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems.

This second edition cancels and replaces the first edition (ISO 10524-1:2006), which has been technically revised.

The main changes compared to the previous edition are as follows:

• the common requirements have been aligned with ISO 10524-2 and ISO 10524-3;

• thisdocumenthasbeenrestructuredaccordingtothenew ISOtemplate andassociated renumbering;

• a complete schedule has been introduced;

— all type tests have been reviewed.

A list of all parts in the ISO 10524 series can be found on the ISO website.

Introduction

Pressure regulators are used to reduce high cylinder pressure to a lower pressure suitable for use with medical equipment or for delivery of gas directly to a patient.

These functions cover a wide range of inlet and outlet pressures and flows which require specific design characteristics. It is important that the operating characteristics of pressure regulators are specified and tested in a defined manner.

A pressure regulator normally has coupled to it a device which controls the flow, such as a flow control device or a fixed orifice. The flow can be indicated by a flowmeter or by a flowgauge.

It is essential that regular inspection and maintenance be undertaken to ensure that the pressure regulator continues to meet the requirements of this document.

This document pays particular attention to

— use of suitable materials,

— safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition),

• gas specificity,

• cleanliness,

— type testing,

— marking, and

— information supplied by the manufacturer.

Annex A contains rationale statements for some of the requirements of this document. The clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale included to provide additional insight into the reasoning that led to the requirements and recommendations that have been incorporated into this document. It is considered that knowledge of the reasons for the requirements will not only facilitate the proper application of this document, but will expedite any subsequent revisions.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

that there is guidance or rationale related to that item in Annex A.

In this document, the following print types are used:

— requirements and definitions: roman type;

• informative material appearing outside of tables, such as notes, examples and references: in smaller

  type. Normative text of tables is also in a smaller type;

• test specifications: italic type;

• terms defined in clause 3 of this document or as noted: small capitals type.

Pressure regulators for use with medical gases —

Part 1:

Pressure regulators and pressure regulators with flow- metering devices

1. Scope

   This document 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.

   This document applies to pressure regulators:

   1. intended to be connected to cylinders by the operator;

   2. 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.

   
   

2. Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 32, Gas cylinders for medical use — Marking for identification of content

ISO 407, Small medical gas cylinders — Pin-index yoke-type valve connections

ISO 5145, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning

ISO 7000, Graphical symbols for use on equipment — Registered symbols

ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum

ISO 10297:2014, Gas cylinders — Cylinder valves — Specification and type testing

ISO 14971, Medical devices — Application of risk management to medical devices

ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen