National foreword

This British Standard is the UK implementation of EN 13060:2025. It supersedes BS EN 13060:2014+A1:2018, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization and Associated Equipment and Processes.

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.

This publication has been prepared under a mandate given to the European Standards Organizations by the European Commission and the European Free Trade Association. It is intended to support requirements of the EU legislation detailed in the European Foreword. A European Annex, usually Annex ZA or ZZ, describes how this publication relates to that EU legislation.

For the Great Britain market (England, Scotland and Wales), if UK Government has designated this publication for conformity with UKCA marking (or similar) legislation, it may contain an additional National Annex. Where such a National Annex exists, it shows the correlation between this publication and the relevant UK legislation. If there is no National Annex of this kind, the relevant Annex ZA or ZZ in the body of the European text will indicate the relationship to UK regulation applicable in Great Britain. References to EU legislation may need to be read in accordance with the UK designation and the applicable UK law. Further information on designated standards can be found at www.bsigroup.com/standardsandregulation.

For the Northern Ireland market, UK law will continue to implement relevant EU law subject to periodic confirmation. Therefore Annex ZA/ZZ in the European text, and references to EU legislation, are still valid for this market.

UK Government is responsible for legislation. For information on legislation and policies relating to that legislation, consult the relevant pages of www.gov.uk.

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 August 2025.

This European Standard was approved by CEN on 23 June 2025.

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, Czechia, 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, Türkiye and United Kingdom.

European foreword

This document (EN 13060:2025) has been prepared by Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is held by DIN.

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 February 2026, and conflicting national standards shall be withdrawn at the latest by February 2026.

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.

This document supersedes EN 13060:2014+A1:2018.

In comparison with the previous edition, the following technical modifications have been made:

the structure of the main text has been widely adopted to the structure of ISO/TS 22421:2021;
update of normative references;
update of terms and definitions to align with EN ISO 11139:2018 and EN ISO 11139:2018/A1:2024;
for requirement on non-condensable gases test, reference is made to EN 285:2015+A1:2021;
considerations of aspect of standardization in moist heat sterilization to align with EN ISO 17665:2024.

This document has been prepared under a standardization request addressed to CEN by the European Commission. The Standing Committee of the EFTA States subsequently approves these requests for its Member States.

For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this document.

In this document, the following verbal forms are used:

“shall” indicates a requirement;
“should” indicates a recommendation;
“may” indicates a permission;
“can” indicates a possibility or capability; and
“must” is used to express an external constraint.

In this document notes are used for giving additional information intended to assist the understanding or use of the text of document. The document shall be usable without the notes.

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

According to the CEN-CENELEC Internal Regulations, the national standards organisations 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, Türkiye and the United Kingdom.

Introduction

Small steam sterilizers are widely used for medical purposes, e.g. in general medical practice, dentistry, podiatry, facilities for personal hygiene and beauty care and also veterinary practice. They are also used for materials and equipment which are likely to come into contact with blood or bodily fluids, e.g. implements used by beauty therapists, tattooists, body piercers and hairdressers. The specific nature of such loads used within these fields of application call for different performance requirements for the sterilization cycles and hence different corresponding test methods.

This document provides minimum requirements for small steam sterilizers and associated test methods. Performance is defined by reference to standard test loads. These are used to define a basic minimum performance and are not necessarily related to specific medical devices. It is the responsibility of the user and the manufacturer of the device to be sterilized to determine that any particular cycle is suitable for sterilizing a particular device. The performance tests specified in this document can also be used by the manufacturer of the device to be sterilized to specify the appropriate performance for decontamination processes according to the requirements for information to be given by medical device manufacturers according to EN ISO 17664‑1. This will enable users to identify the specific sterilizer performance required to safely process their devices.

The performance requirements specified in this document are not intended for the process to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. However, some national regulations require the use of modified steam processes as part of a general prion decontamination programme.

It is essential that the sterilizer and ancillary equipment is used only for the sterilization of the type of products for which it is designed. The choice of sterilizer, sterilization cycle or quality of services provided can be inappropriate for a particular product. Therefore, the suitability of a sterilization procedure for a particular product is verified by validation, see EN ISO 17665. Conformance with these requirements for development, validation and routine control of sterilization process ensures that the sterilization process is both reliable and reproducible so that predictions can be made, with reasonable confidence, that there is low probability of there being a viable microorganism present on a health care product after sterilization.

1 Scope

This document specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.

This document applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.

This document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).

The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).

This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.

This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).

This document does not specify requirements for the validation and routine control of sterilization by moist heat.

NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665.

This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

2 Normative references

3 Terms and definitions

4 General

4.1 Product definition

4.2 Equipment development

4.3 Calibration

5 Equipment design and construction

5.1 Safety and security

5.2 Chamber

5.3 Materials

5.4 Interlocks

5.5 Test connections

5.6 Vibration

5.7 User interfaces

5.8 Transport

6 Indicating, monitoring, controlling and recording

6.1 General

6.2 Automatic control

6.3 Software

6.4 Control and monitoring system

6.5 Failure

6.6 Instrumentation

6.7 Indicating devices

6.8 Recorders

6.9 Process

7 Services and local environment

7.1 General

7.2 Sterilizing agent and sterilant

7.3 Electrical supply

7.4 Water

7.5 Steam

7.6 Vacuum

7.7 Drains

7.8 Lighting

7.9 Compressed air

7.10 Air and inert gases

7.11 Ventilation

8 Emissions

8.1 Electromagnetic emissions

8.2 Noise

8.3 Heat emission

9 Test instrumentation

9.1

9.2

9.3

9.4

9.5

9.6

10 Performance and assessment

10.1 General

10.2 Chamber integrity

10.3 Attainment of conditions

10.4 Performance verification

10.5 Drying

10.6 Microbiological performance

10.7 Pressure change

11 Information supplied by the manufacturer

11.1 General

11.2 Information to be made available prior to purchase

11.3 Marking

11.4 Label

11.5 Instructions for use

11.6 Technical description

Bibliography

BS EN 13060:2025

Sterilizers for medical purposes. Small steam sterilizers. Requirements and testing

Current

Published:

31 Aug 2025