National foreword

This British Standard is the UK implementation of EN ISO 10079‑4:2021. It is identical to ISO 10079‑4:2021.

The UK participation in its preparation was entrusted to Technical Committee CH/121/-/4, Medical Suction Equipment.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2021.

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 of 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 www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment subcommittee SC 8, Suction devices,in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment,in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

A list of all parts in the ISO 10079 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

Previously the ISO 10079 series of medical suction equipment standards comprised parts ISO 10079‑1,^[²^] ISO 10079‑2^[³^] and ISO 10079‑3^[⁴^] which had many common requirements. It was thought that combining these common requirements into this new part 4 would prevent the inconsistencies that had resulted from developing three different parts with common requirements and would make any future revision/amendment easier to manage.

This document contains those requirements that are common to electrically, manually and gas-powered medical suction equipment.

This European Standard was approved by CEN on 26 July 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

European foreword

This document (EN ISO 10079‑4:2021) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2022, and conflicting national standards shall be withdrawn at the latest by April 2022.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 10079‑4:2021 has been approved by CEN as EN ISO 10079‑4:2021 without any modification.

1 Scope

This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series.

This document is not applicable to the following:

end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
syringes;
dental suction equipment;
anaesthetic gas scavenging systems;
laboratory suction;
autotransfusion systems;
mucus extractors including neonatal mucus extractors;
suction equipment where the collection container is downstream of the vacuum pump;
ventouse (obstetric) equipment;
suction equipment marked for endoscopic use only; and
plume evacuation systems.

2 Normative references

3 Terms and definitions

4 General requirements

4.1 Risk management

4.2 Usability

4.3 Clinical studies

4.4 Biophysical or modelling research

4.5 Test methods

5 Materials

5.1 Natural rubber latex

5.2 Cleaning, disinfection and sterilization

6 Design requirements

6.1 General

6.2 Collection containers

6.3 Connections

6.4 Suction tubing and intermediate tubing

6.5 Vacuum level indicators

6.6 Environmental conditions for transport and storage

7 Performance requirements

7.1 Operating position

7.2 Protection devices

7.3 Noise

7.4 Air leakage

7.5 Vacuum levels and free air flows

7.6 Accuracy

7.7 Pharyngeal suction equipment

8 Additional/alternative requirements for suction equipment, suction tubing and intermediate tubing designed for field use or transport use

8.1 Physical requirements

8.2 Strength

8.3 Stability

8.4 Environmental conditions during operation

8.5 Collection container capacity

9 Information supplied by the manufacturer

9.1 General

9.2 Symbols

9.3 Marking

9.4 Instructions for use

Bibliography

BS EN ISO 10079-4:2021

Medical suction equipment - General requirements

Current

Published:

31 Oct 2021